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Find Breast Cancer Clinical Trials That Are Right For You

The clinical trials listed below are open in the U.S. for people with DCIS (stage 0), stage 1, stage 2, stage 3, or stage 4 (metastatic)
breast cancer. Clinical trials are available for people who are newly diagnosed with breast cancer, currently in treatment, experiencing
breast cancer recurrence, living with metastatic disease, as well as breast cancer survivors who have completed treatment.

Use the search box and filters to find a trial that’s right for you.

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(Last updated: July 25, 2024)

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Phase I II III

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AKT

ALK

BARD1

BRCA1/2 (tumor)

BRIP1

CD205

CD70

CHEK2 or CHEK1

dMMR/MSI-H

ESR1

FGFR

HER2/ERBB2

HLA

MET or C-Met

NTRK

PALB2

PIK3CA or PI3K

PTEN

RAD51

RAF (including BRAF)

RAS (KRAS or NRAS)

ROS1

TP53

NEAREST SITE: 3 miles
Kaiser Permanente - San Francisco Medical Center
San Francisco,CA

VISITS: Coincides with targeted therapy

PHASE: II

NCT ID: NCT02693535

Choosing Targeted Therapy Based on a Tumor's Genetic Makeup for Advanced Breast Cancer (TAPUR)

A Basket Study: Targeted Agent and Profiling Utilization Registry (TAPUR) Study Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of using a tumor's genetic profile to select an FDA-approved targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with no standard treatment options. You must have results from a genomic or immunohistochemistry test approved by TAPUR. Full eligibility criteria

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You will receive an FDA-approved targeted therapy based on your tumor's genetic profile.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The targeted therapy you receive will be selected based on your tumor's genetic profile.</li> <li class="seamTextUnorderedListItem">Your treatment may include one or more of the following: Abemaciclib, Futibatinib, Nivolumab, Ipilimumab, Olaparib, Palbociclib, Pembrolizumab, Regorafenib, Sunitinib, Talazoparib, Temsirolimus, Trastuzumab, Pertuzumab, Vemurafenib, Cobimetinib</li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. Basket trials enroll people based on the kind of mutations found in their tumors.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ALK, ATM, BRAF, BRAF V600E/D/K/R, BRCA1/2, CDK4, CDK6, CDKN2A, CSF1R, FGFR1/2/3/4, HER2 (ERBB2), high mutational load and others, KIT, MET, MSI-H, mTOR, NRG1, PALB2, PDGFR, POLD1, POLE, RAF-1, RET, ROS1, TSC, VEGFR</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02693535' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.tapur.org/' target='_blank'>ASCO: TAPUR Study Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/research-and-advocacy/clinical-trials/what-tapur-study' target='_blank'>Cancer.Net (Video): What is the TAPUR Study?</a> </li><li class='seamTextUnorderedListItem'><a href='https://old-prod.asco.org/research-data/tapur-study/study-participation' target='_blank'>ASCO: TAPUR Study Participation</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.onclive.com/conference-coverage/asco-2016/dr-edward-kim-on-ascos-tapur-trial' target='_blank'>OncLive (Video): About TAPUR</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05768139

STX-478 Targeted Therapy for Advanced HR+, HER2- Breast Cancer with a PI3K Mutation

First-in-Human Study of STX-478, a Mutant-Selective PI3Kα Inhibitor as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumor Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of STX-478, an experimental PI3K inhibitor, alone or with fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with advanced (stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a PI3K mutation. You must not have a PTEN, AKT, or mTOR mutation. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STX-478</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STX-478</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">STX-478 is an experimental targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PI3K</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05768139' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.scorpiontx.com/pipeline/' target='_blank'>Scorpion Therapeutics: STX-478 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Medical Center-Mission Bay
San Francisco,CA

VISITS: Please contact research site

PHASE: II

NCT ID: NCT05564377

ComboMATCH: Targeted Therapy Directed by Genetic Testing for Advanced Breast Cancer

Molecular Analysis for Combination Therapy Choice (ComboMATCH) Scientific Title

Purpose

To use genetic testing to match people to treatments and help doctors plan better treatments.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received at least 1 line of therapy for advanced disease or who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Targeted therapy based on genetic testing</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Genetic tests look at the unique genetic material (genes) of tumor cells.</li> <li class="seamTextUnorderedListItem">People with some genetic changes or abnormalities (mutations) may benefit from treatment that targets that particular genetic mutation.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: AKT, ERK, MEK, NF1, RAF, RAS</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05564377' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/news-events/press-releases/2023/combomatch-precision-medicine-cancer-initiative' target='_blank'>National Cancer Institute: ComboMATCH</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/precision-medicine-breast-cancer/about/pac-20385240' target='_blank'>Mayo Clinic: Precision Medicine for Breast Cancer</a> </li></ul>

NEAREST SITE: 3 miles
Research Site
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05417594

AZD9574 Targeted Therapy for Advanced HER2 Negative Breast Cancer With Certain Mutations

A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (CERTIS1) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of AZD9574, an experimental PARP inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer with a tumor or inherited BRCA1, BRCA2, PALB2, RAD51C, or RAD51D mutation. You must not have received treatment with a PARP inhibitor. You must have at least 1 tumor that has not been treated with radiation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD9574, by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD9574 is an experimental targeted therapy called a PARP inhibitor. PARP inhibitors stop the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP).</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">The mutations can be inherited (also called germline) or in a tumor (also called somatic).</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, PALB2, RAD51C, RAD51D</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05417594' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://aacrjournals.org/cancerres/article/82/12_Supplement/2609/702588' target='_blank'>Abstract: AZD9574</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/parp-inhibitors/' target='_blank'>Susan G. Komen: PARP Inhibitors</a> </li></ul>

NEAREST SITE: 3 miles
University of California, San Francisco
San Francisco,CA

VISITS: 1 visit every 3 weeks

PHASE: I

NCT ID: NCT05694715

Niraparib Targeted Therapy and Irinotecan Chemotherapy for Advanced Breast Cancer with BRCA1, BRCA2, ATM, and PALB2 Mutations

Combination Therapy of Niraparib and Irinotecan in Cancers With Mutations in DNA Repair Genes Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of niraparib PARP inhibitor with irinotecan chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with a BRCA1, BRCA2, ATM, and/or PALB2 mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, 1 week on, 2 weeks off</li> <li class="seamTextUnorderedListItem">Irinotecan (Camptosar®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®) is a type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA.</li> <li class="seamTextUnorderedListItem">Irinotecan (Camptosar®) is a type of chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Niraparib (Zejula®) and irinotecan (Camptosar®) are approved to treat certain types of cancer. Their use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, ATM, PALB2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05694715' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617007.html' target='_blank'>Medline Plus: Niraparib (Zejula®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a608043.html' target='_blank'>Medline Plus: Irinotecan (Camptosar®)</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Medical Center-Mission Bay/Benioff Children's Hospital
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03990896

Talazoparib in Women With Metastatic Triple Negative or HR+, HER2- Breast Cancer with a Tumor (Not Inherited) BRCA1/2 Mutation

Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic BRCA Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial Scientific Title

Purpose

To study the anti-cancer activity of the PARP inhibitor Talazoparib (Talzenna®) in breast cancer tumors that test positive for a tumor (not inherited) BRCA 1 or BRCA 2 mutation.

Who is this for?

Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. Your tumor must test positive for a BRCA 1 or a BRCA 2 tumor (not inherited) mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a type of targeted therapy called a PARP inhibitor. It prevents the PARP protein from repairing damaged DNA in tumor cells.</li> <li class="seamTextUnorderedListItem">BRCA1/2 mutations are called germline when they are inherited. </li> <li class="seamTextUnorderedListItem">BRCA1/2 mutations are called somatic when they are not inherited.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA 1 (tumor), BRCA 2 (tumor)</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03990896' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/somatic-mutation' target='_blank'>NCI Drug Dictionary: Somatic Mutation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com/?source=google&HBX_PK=s_talazoparib&skwid=43700039109817433' target='_blank'>Pfizer Oncology: Talzenna®</a> </li><li class='seamTextUnorderedListItem'><a href='https://blog.dana-farber.org/insight/2016/07/how-do-parp-inhibitors-work-in-cancer/' target='_blank'>Dana-Farber Cancer Institue: How Do PARP Inhibitors Work In Cancer? (Video)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/publications/oncology-live/2017/vol-18-no-13/blurring-the-lines-between-germline-and-somatic-mutations-in-cancer' target='_blank'>OncLive: Blurring the Lines Between Germline and Somatic Mutations in Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/s41416-018-0127-5' target='_blank'>Journal Article: BRCA1/2 Testing: Therapeutic Implications for Breast Cancer Management</a> </li></ul>

NEAREST SITE: 3 miles
University of California San Francisco (UCSF)
San Francisco,CA

VISITS: 1 visit every week for 3-6 months

PHASE: II

NCT ID: NCT01042379

I-SPY 2: Personalized Treatment Before Surgery for Stage II-III Breast Cancer

I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of standard of care therapy compared to standard of care therapy with an experimental drug chosen based on your tumor's biomarkers.

Who is this for?

People with stage II or stage III breast cancer who have not yet received treatment and whose cancer is high-risk for recurrence. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups and receive the following before surgery: Group 1: Standard of Care <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> </ul> Group 2: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> <li class="seamTextUnorderedListItem">At least 1 experimental therapy chosen based on your tumor's biomarkers</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">4 MRIs</li> <li class="seamTextUnorderedListItem">2 biopsies</li> <li class="seamTextUnorderedListItem">Blood draws</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Targeted therapy is treatment specific to an individual's tumor type, which are called biomarkers.</li> <li class="seamTextUnorderedListItem">This clinical trial has an adaptive design. This means that experimental drugs will be added during the trial, and experimental drugs that are not more effective than standard of care therapy will be removed.</li> <li class="seamTextUnorderedListItem">At least 80% of people who enroll will receive an experimental drug.</li> <li class="seamTextUnorderedListItem">All drugs will be given before surgery (neoadjuvant therapy). This allows researchers to see how your tumor is responding to the drugs.</li> <li class="seamTextUnorderedListItem">For this trial, cancer is considered high-risk for recurrence if it tests MammaPrint Low (only if your tumor is ER- or ER+, HER2+) or MammaPrint High.</li> <li class="seamTextUnorderedListItem">MammaPrint is a genomic test that identifies genes in your tumor and gives two types of recurrence risk scores: low risk or high risk.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT01042379' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ispypatient.org/' target='_blank'>Quantum Leap Healthcare Collaborative: I-SPY Patient Website</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/screening-testing/mammaprint-test' target='_blank'>Breastcancer.org: MammaPrint</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/32701140/' target='_blank'>Journal Article: Three-Year Follow-Up Analysis for the I-SPY 2 Adaptively Randomized Clinical Trial</a> </li></ul>

NEAREST SITE: 3 miles
UCSF
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05307705

LOXO-783 Targeted Therapy for Advanced Breast Cancer with a PIK3CA Mutation

A Study of LOXO-783 Administered as Monotherapy and in Combination With Anticancer Therapies for Patients With Advanced Breast Cancer and Other Solid Tumors With a PIK3CA H1047R Mutation Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of LOXO-783, an experimental targeted therapy called a PI3Kα inhibitor, alone or with hormone therapy, targeted therapy, and/or chemotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) cancer (including breast cancer) with a PIK3CA mutation who have received up to 5 lines of treatment. If your cancer is estrogen receptor positive (ER+), you must be postmenopausal. Full eligibility criteria

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You will be assigned to 1 of 6 groups based on when you enroll: Group 1: LOXO-783 Alone at Different Doses <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li> </ul> Group 2: LOXO-783 with Hormone Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection or imlunestrant, by mouth</li> </ul> Group 3: LOXO-783 with Targeted Therapy and Hormone Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth</li> <li class="seamTextUnorderedListItem">Physician's choice of aromatase inhibitor, by mouth or fulvestrant (Faslodex®), by injection or imlunestrant, by mouth</li> </ul> Group 4: LOXO-783 with Hormone Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Group 5: LOXO-783 with Chemotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV</li> </ul> Group 6: LOXO-783 Alone <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783, by mouth</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LOXO-783 is an experimental targeted therapy called a PI3Kα inhibitor. If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated which allows cancer cells to grow. LOXO-783 may block the PI3K pathway.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) and imlunestrant are hormone therapies called selective estrogen receptor degraders (SERDs). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is approved, and imlunestrant is experimental.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes that help cancer grow.</li> <li class="seamTextUnorderedListItem">If you are in Group 2, you will receive anastrozole (Arimidex®), exemestane (Aromasin®), or letrozole (Femara®).</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors are hormone therapies that block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05307705' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.loxooncology.com/pipeline' target='_blank'>Loxo Oncology/ Eli Lilly Drug Information Page: LOXO-783 and Imlunestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://finance.yahoo.com/news/loxo-oncology-lilly-announces-details-130000189.html' target='_blank'>Eli Lilly Press Release: LOXO-783</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.newswire.ca/news-releases/lilly-announces-new-clinical-data-from-verzenio-and-oral-serd-programs-at-the-american-society-of-clinical-oncology-annual-meeting-859069920.html' target='_blank'>Eli Lilly Press Release: Imlunestrant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/taxol' target='_blank'>Breastcancer.org: Paclitaxel (Taxol®)</a> </li></ul>

NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05831995

ABM-168 Targeted Therapy for Advanced Breast Cancer with RAS, RAF, or NF-1 Mutations

A Phase I, First-In-Human, Multicenter, Open Label, Dose Escalation and Dose Expansion Study to Evaluate the Safety and Efficacy of ABM-168 Administered Orally in Adult Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of ABM-168, an experimental MEK inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with RAS, RAF, or NF-1 mutations who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABM-168, by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ABM-168 is an experimental targeted therapy called a MEK inhibitor that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05831995' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.clinicaltrialsarena.com/news/abm-first-patient-solid-tumours/' target='_blank'>ABM Therapeutics Corporation: ABM-168 Press Release</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/mek-inhibitor' target='_blank'>National Cancer Institute: MEK Inhibitor</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2022-0763.html' target='_blank'>MD Anderson Cancer Center: Trial Information Page</a> </li></ul>

NEAREST SITE: 8 miles
Epic Care Partners in Cancer Care
Emeryville,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT03994796

Genetic Testing for Choosing a Targeted Therapy for Brain Metastases that Test Positive for Certain Mutations

Genomically-Guided Treatment Trial in Brain Metastases Scientific Title

Purpose

To study the anti-cancer activity of choosing a targeted therapy for brain metastases based on the genetic mutations found in your tumors.

Who is this for?

People with metastatic (stage IV) breast cancer that has spread (metastasized) to your brain with a gene mutation or alteration in: NTRK, ROS1, CDK or PI3K. You must have already received at least one treatment for metastatic disease. Full eligibility criteria

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You will be assigned to 1 of 3 groups depending on which genetic mutations are found in your tumors: Group 1: CDK-mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, twice a day, ongoing</li> </ul> Group 2: PI3K-mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GDC-0084, by mouth, daily, ongoing</li> </ul> Group 3: NTRK or ROS1-mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Entrectinib (Rozlytrek®), by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor samples from your brain and other parts of your body will be tested for mutations. This is called genomic testing.</li> <li class="seamTextUnorderedListItem">You will be assigned a targeted therapy based on which genetic mutations are found in your tumors.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer. </li> <li class="seamTextUnorderedListItem">Targets or mutations: NTRK, ROS1, CDK, PI3K</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03994796' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://mbcn.org/brain-mets/' target='_blank'>Metastatic Breast Cancer Network: Brain Mets</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verzenio.com/hcp/patient-profiles' target='_blank'>Eli Lilly & Company Drug Information Page: Verzenio® (Abemaciclib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.rozlytrek.com' target='_blank'>Genentech USA Drug Information Page: Rozlytrek (Entrectinib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/pi3k-inhibitor-gdc-0084' target='_blank'>NCI Drug Dictionary: GDC-0084</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/targeting-sanctuary-site-options-when-breast-cancer-metastasizes-brain' target='_blank'>Journal Article: Targeting the Sanctuary Site, Options when Breast Cancer Metastasizes to the Brain</a> </li></ul>

NEAREST SITE: 15 miles
Marin Cancer Care Inc
Greenbrae,CA

VISITS: 2 visits for 1 month, then 1 visit every month

PHASE: III

NCT ID: NCT05646862

Targeted Therapy with Fulvestrant for HR+, HER2- Advanced Breast Cancer with a PIK3CA Mutation

A Phase III, Multicenter, Randomized, Open-Label Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Versus Alpelisib Plus Fulvestrant in Patients With Hormone Receptor-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Who Progressed During or After CDK4/6 Inhibitor and Endocrine Combinatio... Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of inavolisib, an experimental PI3K inhibitor, with fulvestrant (Faslodex®) hormone therapy compared to alpelisib (Piqray®) PI3K inhibitor with fulvestrant (Faslodex®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a PIK3CA mutation. You must have received treatment with a CDK 4/6 inhibitor with hormone therapy as 1 of up to 2 lines of therapy for advanced/metastatic disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), every 2 weeks for 1 month, then monthly</li> </ul> Group 2: Standard Treatment <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), every 2 weeks for 1 month, then monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib is an experimental targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05646862' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.genentechoncology.com/pipeline-molecules/inavolisib.html' target='_blank'>Genentech Drug Information Page: Inavolisib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex#:~:text=Faslodex%20(chemical%20name%3A%20fulvestrant),%2C%20HER2%2Dnegative%20breast%20cancer.' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

NEAREST SITE: 27 miles
Stanford University
Stanford,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04756765

Talazoparib PARP Inhibitor for Advanced Breast Cancer with a PALB2 Mutation

A Phase 2 Clinical Trial of Talazoparib Monotherapy for PALB2 Mutation Associated Advanced Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of talazoparib (Talzenna®) PARP inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer with a PALB2 mutation who have received 0-3 treatments for advanced/metastatic disease. You must not have a BRCA1/2 mutation or received treatment with a PARP inhibitor. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04756765' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/talzenna' target='_blank'>Breastcancer.org: Talazoparib (Talzenna®)</a> </li></ul>

NEAREST SITE: 27 miles
Stanford University School of Medicine
Stanford,CA

VISITS: 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT04300556

Experimental Antibody-Drug Conjugate MORAb-202 for Women with Metastatic Triple Negative Breast Cancer that Tests Positive for FRA

A Multicenter, Open-Label Phase 1/2 Trial Evaluating the Safety, Tolerability, and Efficacy of MORAb-202, a Folate Receptor Alpha (FRÎ±)-Targeting Antibody-drug Conjugate (ADC) in Subjects With Selected Tumor Types Scientific Title

Purpose

To study the safety, anti-cancer activity and side effects of giving the experimental antibody-drug conjugate MORAb-202.

Who is this for?

Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have already received a platinum-based chemotherapy and whose tumor tests positive for FRA. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MORAb-202, by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells. Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">MORAb-202 is an experimental ADC. </li> <li class="seamTextUnorderedListItem">Its antibody targets FAR, a protein, and it delivers an anti-cancer drug called eribulin mesylate.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling women with other types of cancer. </li> <li class="seamTextUnorderedListItem">Targets or mutations: FRA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04300556' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Getting to the Target, Antibody-Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2019.37.15_suppl.5544' target='_blank'>Journal Article Abstract: MORAb-202</a> </li></ul>

NEAREST SITE: 28 miles
Stanford University
Palo Alto,CA

VISITS: 1 visit per week, ongoing

PHASE: I-II

NCT ID: NCT04092673

eFT226 in Advanced Breast Cancer That Tests Positive for HER2, ERBB3, FGFR1, FGFR2, or KRAS Mutations

A Phase 1-2 Dose-Escalation and Cohort-Expansion Study of Intravenous eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies Scientific Title

Purpose

To evaluate the safety and effects (good and bad) of eFT226 (Zotatifin), an experimental targeted therapy that blocks eIF4A1.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer that has been treated with standard therapies and tests positive for a mutation in HER2 (ERRB2), ERBB3, FGFR1, FGFR2, or KRAS. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">eFT226 (Zotatifin), by IV, weekly, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">eFT226 (Zotatifin) is an experimental targeted therapy that blocks eIF4A1. </li> <li class="seamTextUnorderedListItem">This study also is enrolling patients with other types of solid tumors that have these mutations.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HER2 (ERBB2), ERBB3, FGFR1, FGFR2, or KRAS</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04092673' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.globenewswire.com/news-release/2019/11/05/1941103/0/en/eFFECTOR-Therapeutics-Initiates-Phase-1-2-Safety-and-Efficacy-Study-of-Zotatifin-eFT226-in-Patients-with-Advanced-Solid-Tumor-Malignancies.html' target='_blank'>Drug Company Press Release: eFT226 (Zotatifin)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/targeted-therapy-for-breast-cancer.html' target='_blank'>American Cancer Society: Targeted Therapies for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/cddis2014542' target='_blank'>Journal Article: The Malignant Phenotype in Breast Cancer is Driven by eIF4A1-mediated Changes in The Translational Landscape</a> </li></ul>

NEAREST SITE: 28 miles
Kaiser Permanente Medical Center - Vallejo
Vallejo,CA

VISITS: 1-3 visits per month

PHASE: III

NCT ID: NCT05501886

Gedatolisib pan-PI3K/mTOR Inhibitor for Advanced HR+, HER2- Breast Cancer

Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of gedatolisib, an experimental pan-PI3K and mTOR inhibitor, with fulvestrant (Faslodex®) hormone therapy, with or without palbociclib (Ibrance®) CDK 4/6 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with or without a PIK3CA mutation who have received treatment with a CDK 4/6 inhibitor with an aromatase inhibitor. You must not have received more than 1 chemotherapy for advanced disease or 2 lines of hormone therapy. Full eligibility criteria

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You will be randomly assigned to 1 of 4 groups depending on your cancer: Group 1: Experimental, with or without PIK3CA Mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> </ul> Group 2: Experimental, with or without PIK3CA Mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib, by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> </ul> Group 3: Standard of Care, without PIK3CA Mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> </ul> Group 4: Standard of Care, with PIK3CA Mutation <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gedatolisib is an experimental targeted therapy called a pan-PI3K/mTOR inhibitor. Blocking PI3K and mTOR may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) is a type of targeted therapy called a CDK 4/6 inhibitor. CDK 4/6 inhibitors block two enzymes, CDK 4 and CDK 6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05501886' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.celcuity.com/gedatolisib/' target='_blank'>Celcuity Drug Information Page: Gedatolisib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/ibrance' target='_blank'>Breastcancer.org: Palbociclib (Ibrance®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li></ul>

NEAREST SITE: 210 miles
PCR Oncology
Arroyo Grande,CA

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT05554354

Fulvestrant Alone or With Binimetinib Targeted Therapy for Metastatic HR+, HER2- Breast Cancer with a NF1 Mutation

A ComboMATCH Treatment Trial EAY191-N2: Phase 2 Trial of Fulvestrant and Binimetinib in Patients With Hormone Receptor-Positive Metastatic Breast Cancer With a Frameshift or Nonsense Mutation or Genomic Deletion in NF1 Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of fulvestrant (Faslodex®) hormone therapy alone or with binimetinib (Mektovi®) MEK inhibitor.

Who is this for?

People with metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a NF1 mutation who have received treatment with a CDK 4/6 inhibitor. You must not have received more than 1 line of chemotherapy for metastatic disease. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> <li class="seamTextUnorderedListItem">Binimetinib (Mektovi®), by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CT, MRI, or bone scan, 2 times</li> <li class="seamTextUnorderedListItem">Biopsy, 2 times</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors, which may inhibit the growth of estrogen-sensitive tumor cells.</li> <li class="seamTextUnorderedListItem">Binimetinib (Mektovi®) is a type of targeted therapy called a MEK inhibitor that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.</li> <li class="seamTextUnorderedListItem">Targets or mutations: NF1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05554354' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a618041.html' target='_blank'>Medline Plus: Binimetinib (Mektovi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex#:~:text=Faslodex%20(chemical%20name%3A%20fulvestrant),%2C%20HER2%2Dnegative%20breast%20cancer.' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

NEAREST SITE: 339 miles
University of California, Los Angeles
Santa Monica,CA

VISITS: Hospital stay may be required

PHASE: I

NCT ID: NCT05274451

LYL797 CAR T-Cell Immunotherapy for Triple Negative, ROR1 Positive Advanced Breast Cancer

A Phase 1 Study to Assess the Safety and Efficacy of LYL797, ROR1-Targeting CAR T Cells, in Adults With Relapsed and/or Refractory Solid-Tumor Malignancies Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of LYL797, an experimental type of immunotherapy called CAR T-cell therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-), ROR1 positive breast cancer that has progressed on standard treatment. You must not have received T-cell therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LYL797 CAR T-cell therapy</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires 1 biopsy</li> </ul> Please contact research site for treatment schedule. Hospital stay may be required.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">LYL797 is an experimental type of immunotherapy called CAR T-cell/CAR-T therapy.</li> <li class="seamTextUnorderedListItem">CAR-T or CAR T cell therapy is a personalized immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The cells are removed from your blood, modified with chimeric antigen receptors (CARs) that allow them to attack proteins on cancer cells, and then put back in your body.</li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy being used in this study trains the immune system to attack ROR1 positive cancer cells</li> <li class="seamTextUnorderedListItem">This study is also enrolling patients with other types of ROR1 positive cancers.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ROR1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05274451' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://lyell.com/our-pipeline' target='_blank'>Lyell Immunopharma Drug Information Page: LYL797</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/cellular-therapies-program/car-t-cell-therapy/faq-about-car-t-cell-therapy/' target='_blank'>Dana-Farber Cancer Institute: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-adoptive-cell-therapy' target='_blank'>Breastcancer.org: CAR T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li></ul>

NEAREST SITE: 339 miles
University of California, Los Angeles
Santa Monica,CA

VISITS: 2 visits per month

PHASE: I

NCT ID: NCT04890613

CX-5461 for Advanced Breast Cancer with a BRCA2 or PALB2 Mutation

Phase Ib Expansion Study of CX-5461 in Patients With Solid Tumours and BRCA2 and/or PALB2 Mutation Scientific Title

Purpose

To determine the safety and best dose of CX-5461, an experimental targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have a BRCA2 or PALB2 germline (genetic) mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-5461, by IV, 2 times per month</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-5461 is an experimental targeted therapy. </li> <li class="seamTextUnorderedListItem">It targets cells with a Homologous Recombination Deficiency (HRD) mutation. </li> <li class="seamTextUnorderedListItem">It works by slowing down the growth of cancer cells or causing cancer cells to die.</li> <li class="seamTextUnorderedListItem">This trial also is enrolling patients with other types of advanced cancers.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA2, PALB2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04890613' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/senhwa-biosciences-receives-us-fda-study-may-proceed-letter-to-treat-brca2-or-palb2-solid-tumors-with-cx-5461-301198347.html' target='_blank'>Senhwa Biosciences Press Release: CX-5461</a> </li></ul>

NEAREST SITE: 339 miles
UCLA Hematology/Oncology
Santa Monica,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05887492

TNG260 Targeted Therapy with Immunotherapy for Advanced Breast Cancer with STK11 Mutations

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of TNG260 as Single Agent and in Combination With an Anti-PD-1 Antibody In Patients With STK11 Mutated Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of TNG260, an experimental targeted therapy, with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with STK11 mutations. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TNG260, by mouth</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TNG260 is an experimental targeted therapy called a CoREST inhibitor. CoREST inhibitors may activate the immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Targets or mutations: STK11</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05887492' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tangotx.com/pipeline/' target='_blank'>Tango Therapeutics: TNG260 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.tangotx.com/programs/corest/' target='_blank'>Tango Therapeutics: CoREST Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 341 miles
Lawrence J. Ellison Institute for Transformative Medicine
Los Angeles,CA

VISITS: 1 visit every 3 weeks

PHASE: III

NCT ID: NCT05894239

Inavolisib and Phesgo for Advanced HER2 Positive Breast Cancer with a PIK3CA Mutation

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib in Combination With Phesgo Versus Placebo in Combination With Phesgo As Maintenance Therapy After First Line Induction Therapy in Participants With PIK3CA-Mutated HER2-Positive Locally Advanced or Metastatic Breast Cancer... Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of inavolisib, an experimental PI3K inhibitor, with Phesgo anti-HER2 targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer with a PIK3CA mutation who have not received treatment for advanced disease (except for hormone therapy if HR+). Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1: Experimental <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Chemotherapy</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Inavolisib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy (optional, if relevant)</li> </ul> Group 2: Control <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Chemotherapy</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for inavolisib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy (optional, if relevant)</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will first receive induction therapy (initial therapy used when treating a disease) with Phesgo and chemotherapy.</li> <li class="seamTextUnorderedListItem">Inavolisib is an experimental targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Phesgo is a combination of two anti-HER2 targeted therapies: Perjeta® (pertuzumab) and Herceptin® (trastuzumab). It also includes a protein called hyaluronidase which helps your body absorb the targeted therapies.</li> <li class="seamTextUnorderedListItem">Pertuzumab and trastuzumab are typically given by IV. With Phesgo, you can receive these therapies by injection, which shortens the length of time it takes to receive treatment.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05894239' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.gene.com/medical-professionals/pipeline/inavolisib-gdc-0077' target='_blank'>Genentech: Inavolisib Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/phesgo' target='_blank'>Breastcancer.org: Phesgo</a> </li></ul>

NEAREST SITE: 341 miles
Ellison Institute of Technology
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05252390

NUV-868 Targeted Therapy for Advanced Triple Negative Breast Cancer

Phase 1/2 Safety and Efficacy Study of NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of NUV-868, an experimental targeted therapy, alone or with olaparib (Lynparza®) or enzalutamide (Xtandi®) targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received at least 1 line of chemotherapy for advanced or metastatic disease. If you have a BRCA mutation, you must have received treatment with talazoparib (Talzenna®) or olaparib (Lynparza®). Full eligibility criteria

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You will be assigned to 1 of 3 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NUV-868, by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NUV-868, by mouth, daily</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NUV-868, by mouth, daily</li> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NUV-868 is an experimental targeted therapy called a BET inhibitor. Blocking BET may help slow or stop the growth of cancer cells.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®) is a type of targeted therapy called an androgen receptor (AR) inhibitor. It is approved to treat advanced prostate cancer.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05252390' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nuvationbio.com/pipeline/' target='_blank'>Nuvation Bio: NUV-868 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/lynparza' target='_blank'>Breastcancer.org: Olaparib (Lynparza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a612033.html' target='_blank'>MedlinePlus: Enzalutamide (Xtandi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org/' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>

NEAREST SITE: 348 miles
University of Southern California, Norris Comprehensive Cancer Center
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05683418

TOS-358 Targeted Therapy for Advanced HER2- Breast Cancer With a PIK3CA Mutation

A Study to Evaluate the Safety and Tolerability of the Covalent Phosphoinositide-3-Kinase (PI3K)-Alpha Inhibitor, TOS-358, in Adult Subjects With Select Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of TOS-358, an experimental PI3K inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer with a PIK3CA mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TOS-358, by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">TOS-358 is an experimental targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated, allowing cancer cells to grow. TOS-358 may slow or stop cancer cells from growing by blocking this pathway.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05683418' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.totusmedicines.com/pipeline' target='_blank'>Totus Medicines: TOS-358 Drug Information Page</a> </li></ul>

NEAREST SITE: 348 miles
USC Norris Comprehensive Cancer Center
Los Angeles,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04585750

Targeted Therapy for Advanced Breast Cancer With a TP53 Y220C Mutation

A Phase 1/2 Open-label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PC14586 in Patients With Advanced Solid Tumors Harboring a p53 Y220C Mutation (PYNNACLE) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of PC14586, an experimental p53 reactivator, alone or with pembrolizumab (Keytruda®) PD-1 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with a TP53 Y220C mutation who have received at least 1 line of therapy. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PC14586, by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PC14586, by mouth, daily</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PC14586 is an experimental targeted therapy called a p53 reactivator which may stop the mutated p53 protein from working and cause cancer cell death.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: TP53 Y220C</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04585750' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pmvpharma.com/pipeline/' target='_blank'>PMV Pharmaceuticals: PC14586 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li></ul>

NEAREST SITE: 348 miles
USC / Norris Comprehensive Cancer Center
Los Angeles,CA

VISITS: 1 visit every 6 months for 5 years

PHASE: III

NCT ID: NCT04711109

Denosumab to Prevent Breast Cancer in Women With an Inherited BRCA1 Mutation

BRCA-P: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, International Phase 3 Study to Determine the Preventive Effect of Denosumab on Breast Cancer in Women Carrying a BRCA1 Germline Mutation Scientific Title

Purpose

To study the safety, effects (good and bad), and ability of denosumab to prevent breast cancer.

Who is this for?

Women aged 25 to 55 who do not have breast cancer and who have an inherited BRCA1 mutation. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Denosumab, by injection, every 6 months for up to 5 years</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for denosumab, by injection, every 6 months for up to 5 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Denosumab is a targeted therapy called a RANK ligand inhibitor. It is used to reduce the risk of bone fractures in people without cancer and to reduce new bone growth in people whose cancer has spread to their bones.</li> <li class="seamTextUnorderedListItem">Denosumab may also reduce the risk of developing breast cancer in women with an inherited (germline) BRCA1 mutation.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA 1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04711109' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerpreventioninitiative.org/projects/prevention-of-breast-cancer-by-denosumab-in-women-carrying-a-brca1-or-brca2-mutation-brca-p-trial/' target='_blank'>Cancer Prevention Initiative: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a610023.html' target='_blank'>MedlinePlus: Denosumab</a> </li></ul>

NEAREST SITE: 353 miles
City of Hope National Medical Center
Duarte,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05325866

Bemarituzumab Targeted Therapy for Advanced Triple Negative Breast Cancer that Expresses FGFR2b

A Phase 1b/2, Multicenter, Open-label Basket Study Evaluating the Safety and Efficacy of Bemarituzumab Monotherapy in Solid Tumors With FGFR2b Overexpression (FORTITUDE-301) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of bemarituzumab, an experimental FGFR2b inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer that expresses FGFR2b who have received at least 1 line of therapy for advanced or metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bemarituzumab (AMG 552), by IV</li> </ul> Please contact research site
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Bemarituzumab (AMG 552) is an experimental targeted therapy called a FGFR2b inhibitor. Targeting FGFR2b may slow or stop cancer cell growth.</li> <li class="seamTextUnorderedListItem">This type of study is called a basket trial. It is enrolling people with other types of cancer based on the kind of mutations found in their tumors.</li> <li class="seamTextUnorderedListItem">Targets or mutations: FGFR2b, FGFR</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05325866' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.amgenpipeline.com/' target='_blank'>Amgen Drug Information Page: Bemarituzumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li></ul>

NEAREST SITE: 362 miles
Research Site
Long Beach,CA

VISITS: Number of visits unavailable

PHASE: III

NCT ID: NCT04964934

Camizestrant with Targeted Therapy for Advanced HR+, HER2- Breast Cancer with an ESR1 Mutation

A Phase III, Double-blind, Randomised Study to Assess Switching to AZD9833 (a Next Generation, Oral SERD) + CDK4/6 Inhibitor (Palbociclib or Abemaciclib) vs Continuing Aromatase Inhibitor (Letrozole or Anastrozole)+ CDK4/6 Inhibitor in HR+/HER2-MBC Patients With Detectable ESR1Mutation Without Disease Progression During 1L Treatment With Aromata... Scientific Title

Purpose

To compare the safety and effects (good and bad) of camizestrant (AZD9833) and a CDK4/6 inhibitor with an aromatase inhibitor and a CDK4/6 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer and an ESR1 mutation. You must not have received treatment with fulvestrant (Faslodex®) or any investigational selective estrogen receptor degrader (SERD). Full eligibility criteria

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You will be randomly assigned to 1 of 6 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily </li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Placebo, by mouth, daily</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily</li> </ul> Group 5 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li> </ul> Group 6 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Placebo for camizestrant (AZD9833), by mouth, daily</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Camizestrant (AZD9833) is an experimental type of anti-estrogen therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Palbociclib (Ibrance®) and abemaciclib (Verzenio®) are CDK4/6 inhibitors, a type of targeted therapy.</li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) and anastrozole (Arimidex®) are aromatase inhibitors, a type of hormone therapy.</li> <li class="seamTextUnorderedListItem">Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women and men will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ESR1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04964934' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/cancer/breast-cancer/treatment/hormone-therapy-for-breast-cancer.html' target='_blank'>American Cancer Society: Hormone Therapy for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/cdk4-6-inhibitors/' target='_blank'>Susan G. Komen: CDK4/6 Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/hormone-therapy/aromatase-inhibitors/' target='_blank'>Susan G. Komen: Aromatase Inhibitors</a> </li></ul>

NEAREST SITE: 381 miles
Hoag Memorial Hospital Presbyterian
Newport,CA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05455619

Evexomostat for Women with Advanced HR+, HER2- Breast Cancer with a PIK3CA Mutation and High Blood Sugar

Phase 1b/2 Study of the Safety and Efficacy of Evexomostat Plus Alpelisib and Fulvestrant in Postmenopausal Women at Risk for Hyperglycemia With Advanced Breast Cancer and a PIK3CA Mutation Following Endocrine Therapy and a CDK4/6 Inhibitor Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of evexomostat (SDX-7320), an experimental polymer drug conjugate, with fulvestrant (Faslodex®) hormone therapy and alpelisib (Piqray®) PI3K inhibitor.

Who is this for?

Women with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a PIK3CA mutation who have high blood sugar. You must have received hormone therapy and a CDK 4/6 inhibitor. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320)</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®)</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) is an experimental polymer drug conjugate (PDC), which is similar to an antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">Evexomostat (SDX-7320) releases fumagillol, a type of targeted therapy called a MetAP2 inhibitor. Blocking MetAP2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women will also be given a drug that will put women in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05455619' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.amelia1.com/' target='_blank'>SynDevRx: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/lead-compound-sdx-7320/' target='_blank'>SynDevRx Drug Information Page: Evexomostat (SDX-7320)</a> </li><li class='seamTextUnorderedListItem'><a href='https://syndevrx.com/science/polymer-drug-conjugation/' target='_blank'>SynDevRx: Polymer Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li></ul>

NEAREST SITE: 383 miles
Arrowhead Regional Medical Center
Colton,CA

VISITS: About 1 visit a week for 5 to 6 months

PHASE: II

NCT ID: NCT03412643

Chemotherapy and HER2-Targeted Therapies Before Surgery for Stage I-III, HER2 Negative Breast Cancer That Shows Other HER2 Activity

An Open-Label Phase II Trial to Evaluate the Efficacy and Safety of Neoadjuvant Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel Plus Trastuzumab and Pertuzumab in Early Stage HER2-Negative Breast Cancer Patients Selected With a Test Measuring Live Cell HER2 Signaling Transduction (FACT 1) Scientific Title

Purpose

To study the effects (good and bad) of chemotherapy combined with the anti-HER2 targeted therapies trastuzumab (Herceptin®) and pertuzumab (Perjeta®) on HER2 negative (HER2-) cancer cells that test positive for other types of HER2 activity.

Who is this for?

Women with stage II or stage III HER2 negative (HER2-) breast cancer whose cancer has HER2 activity based on the Celcuity CELx HER2 (HSF) test and who have not yet started treatment for breast cancer. Full eligibility criteria

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You will receive the following before surgery over 5-6 months: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®) and cyclophosphamide (Cytoxan®), by IV, every 2 or 3 weeks, for 2-3 months</li> </ul> followed by <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, for 3 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks, for 2 months</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks, for 2 months</li> </ul> Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 biopsy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are targeted therapies commonly used to treat HER2 positive (HER2+) breast cancer. </li> <li class="seamTextUnorderedListItem">They are not approved for use on HER2 negative (HER2-) breast cancer. Their use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">The Celcuity CELx HER2 Signaling Function (HSF) test checks breast cancer cells for activity called abnormal HER2 signaling. </li> <li class="seamTextUnorderedListItem">To be eligible for this trial, your cancer cells must test positive for abnormal HER2 signaling.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03412643' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://ww5.komen.org/BreastCancer/TumorCharacteristics.html' target='_blank'>Susan G. Komen: Tumor Characteristics</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies' target='_blank'>Breastcancer.org: Targeted Therapies</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/32036454' target='_blank'>Journal Abstract: New HER2 Negative Breast Cancer Subtype Responsive to Anti-HER2 Therapy Identified</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.oncotarget.com/article/12480/text/' target='_blank'>Journal Article: HER2 Signaling Activity Test</a> </li></ul>

NEAREST SITE: 421 miles
Comprehensive Cancer Centers of Nevada
Las Vegas,NV

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06239467

OKI-219 Targeted Therapy for Advanced HR+ Breast Cancer with PI3K Mutations

PIKture-01: First-in-Human Study of the PI3KÃŽ±H1047R Mutant-Selective Inhibitor OKI-219 as Monotherapy in Participants With Advanced Solid Tumors and in Combination With Endocrine Therapy or HER2-Targeted Therapy in Participants With Advanced Breast Cancer (PIKture-01) Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of OKI-219, an experimental PI3Kα inhibitor, with fulvestrant (Faslodex®) hormone therapy or trastuzumab (Herceptin®) anti-HER2 targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) or HER2 positive (HER2+) breast cancer with a PI3KαH1047R mutation. Full eligibility criteria

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You will be assigned to 1 of 2 groups: Group 1: HR positive, HER2 negative <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OKI-219, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Group 2: HER2 positive <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OKI-219, by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PI3KαH1047R is a common type of PI3KCA mutation.</li> <li class="seamTextUnorderedListItem">OKI-219 is an experimental targeted therapy called a PI3Kα inhibitor. If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated which allows cancer cells to grow. OKI-219 may block the PI3K pathway.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy called a selective estrogen receptor degraders (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy routinely used for HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06239467' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://onkuretherapeutics.com/pipeline/' target='_blank'>OnKure: OKI-219 Drug Information Page</a> </li></ul>

NEAREST SITE: 533 miles
Site 9280
Portland,OR

VISITS: 1 visit every 3 weeks

PHASE: I-II

NCT ID: NCT05565417

IMT-009 Targeted Therapy for Advanced Triple Negative Breast Cancer with a CD161 or CLEC2D Mutation

A Phase 1/2a, First-in-Human (FIH), Open-Label, Dose-Escalation and Dose Expansion Study of the Monoclonal Antibody IMT-009 in Patients With Advanced Solid Tumors or Lymphomas Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of IMT-009, an experimental CD161 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone receptor positive (HR+) breast cancer with a CD161 or CLEC2D mutation who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMT-009, by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMT-009 is an experimental targeted therapy called a CD161 inhibitor. Blocking CD161 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: CD161, CLEC2D</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05565417' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.healio.com/news/hematology-oncology/20220922/fda-clears-ind-application-for-cancer-therapeutic-imt009' target='_blank'>Healio: IMT-009</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/immunitas-therapeutics-receives-fda-clearance-of-ind-application-for-imt-009-in-solid-tumors-and-hematological-malignancies-301628999.html' target='_blank'>Immunitas Therapeutics Press Release: IMT-009</a> </li></ul>

NEAREST SITE: 595 miles
START Mountain Region
West Valley City,UT

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT06253130

IMP1734 PARP Inhibitor for Advanced Breast Cancer

A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation, Dose-optimization, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of PARP1 Selective Inhibitor, IMP1734, as Monotherapy in Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of IMP1734, an experimental PARP inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received chemotherapy and 0-1 lines of a PARP inhibitor. You must have a BRCA1, BRCA2, PALB2, ATM, ATR, CHEK2, FANCA, MLH1, MRE11A, NBN, RAD51C, CDK12, or other homologous recombination repair (HRR) mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMP1734, by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMP1734 is an experimental targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06253130' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.eikontx.com/#pipeline' target='_blank'>Eikon Therapeutics: IMP1734/EIK1003 Drug Information Page</a> </li></ul>

NEAREST SITE: 602 miles
University of Utah Huntsman Cancer Institute
Salt Lake City,UT

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05490472

JAB-2485 Targeted Therapy for Advanced ER+, Triple Negative, or ARID1A Mutated Breast Cancer

A Phase 1/2a, Multi-Center, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Evidence of Antitumor Activity of JAB-2485 in Adult Patients With Advanced Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of JAB-2485, an experimental Aurora A inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) ER positive (ER+), triple negative (ER-, PR-, HER2-), or ARID1A mutated breast cancer who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">JAB-2485, by mouth</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">JAB-2485 is an experimental targeted therapy called an Aurora A inhibitor. Aurora A inhibitors may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ARID1A</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05490472' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/aurora-a-kinase-inhibitor-jab-2485' target='_blank'>National Cancer Institute: JAB-2485</a> </li></ul>

NEAREST SITE: 681 miles
Site 32 - Swedish Medical Center, Swedish Cancer Institute (SCI),Cherry Hill Campus
Seattle,WA

VISITS: 1-2 visits every month

PHASE: I-II

NCT ID: NCT05963997

Samuraciclib CDK7 Inhibitor with Elacestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer with TP53 and ESR1 Mutations

A Phase 1b/2 Open-label Study of Samuraciclib in Combination With Elacestrant in Participants With Metastatic or Locally Advanced Hormone Receptor-positive and Human Epidermal Growth Factor Receptor 2-negative Breast Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of elacestrant (Orserdu®) hormone therapy with samuraciclib, an experimental CDK7 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with TP53 and ESR1 mutations who are receiving or most recently received an aromatase inhibitor with a CDK4/6 inhibitor. You must not have received more than 1 line of hormone therapy for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Samuraciclib, by mouth, daily</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Samuraciclib is an experimental targeted therapy called a CDK7 inhibitor. CDK7 inhibitors may block the CDK7 enzyme that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Elacestrant (Orserdu®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs work by binding to and breaking down estrogen receptors.</li> <li class="seamTextUnorderedListItem">If you are premenopausal or perimenopausal, you will also receive a drug that will put you in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: TP53, ESR1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05963997' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.carricktherapeutics.com/pipeline/cdk7-inhibitor' target='_blank'>Carrick Therapeutics: Samuraciclib Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/orserdu' target='_blank'>Breastcancer.org: Elacestrant (Orserdu®)</a> </li></ul>

NEAREST SITE: 752 miles
The University of Arizona Cancer Center
Tucson,AZ

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05216432

RLY-2608 Alone and With Fulvestrant for Advanced Breast Cancer with a PIK3CA Mutation

A First-in-Human Study of Mutant-selective PI3Kα Inhibitor, RLY-2608, as a Single Agent in Advanced Solid Tumor Patients and in Combination With Fulvestrant in Patients With Advanced Breast Cancer Scientific Title

Purpose

To study the safety, best dose, and effects (good and bad) of RLY-2608 alone and in combination with fulvestrant (Faslodex®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer with a PIK3CA mutation. Full eligibility criteria

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You will be assigned to 1 of 2 groups based on when you enroll: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RLY-2608, by mouth</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RLY-2608, by mouth</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> Additional procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">May require a biopsy</li> </ul> Please contact research site for treatment schedule.
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">RLY-2608 is an experimental targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">If there is a mutation in the PIK3CA gene, the PI3K pathway can become overactivated which allows cancer cells to grow.</li> <li class="seamTextUnorderedListItem">RLY-2608 may block the PI3K pathway.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a hormone therapy approved to treat postmenopausal women with advanced breast cancer.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD).</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05216432' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://ir.relaytx.com/news-releases/news-release-details/relay-therapeutics-announces-dosing-first-patient-first-human-0' target='_blank'>Relay Therapeutics Press Release: RLY-2608</a> </li></ul>

NEAREST SITE: 941 miles
University of Colorado Cancer Center
Aurora,CO

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05230810

Targeted Therapy for Metastatic HER2+ Breast Cancer with a PIK3CA Mutation

This is a Multicenter, Single Arm, Open-label, run-in Phase Ib / Roll-over Phase II Study of Tucatinib in Combination With Alpelisib in Subjects With PIK3CA-mutant HER2-positive Locally Advanced Unresectable or Metastatic Breast Cancer. Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of alpelisib (Piqray®) PI3K inhibitor and tucatinib (Tukysa) anti-HER2 targeted therapy with or without fulvestrant (Faslodex®) hormone therapy.

Who is this for?

People with metastatic (stage IV) HER2 positive (HER2+) breast cancer with a PIK3CA mutation who have received 2+ anti-HER2 targeted therapies. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa), by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection (for people with HR positive breast cancer)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of anti-HER2 targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps HER2+ cancer cells grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors. You will only receive fulvestrant (Faslodex®) if you have HR+ (ER+ and/or PR+) breast cancer.</li> <li class="seamTextUnorderedListItem">Premenopausal and perimenopausal women with HR+ breast cancer will also be given a drug that will put women in temporary menopause.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05230810' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/tukysa' target='_blank'>Breastcancer.org: Tucatinib (Tukysa)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

NEAREST SITE: 948 miles
Sarah Cannon Research Institute at HealthONE
Denver,CO

VISITS: 1 visit a week, ongoing

PHASE: I-II

NCT ID: NCT04561362

Immunotherapy and BT8009 for Metastatic Breast Cancer that Expresses Nectin-4

Phase I/II Study of the Safety, Pharmacokinetics, and Preliminary Clinical Activity of BT8009 in Patients With Nectin-4 Expressing Advanced Malignancies Scientific Title

Purpose

To study the safety, anti-cancer activity, and effects (good and bad) of giving the experimental therapy BT8009 alone or in combination with the PD-1 inhibitor nivolumab (Opdivo®).

Who is this for?

People with metastatic (stage IV) breast cancer that expresses Nectin-4 and who have no standard treatment options available. Full eligibility criteria

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You will be assigned to 1 of 2 groups and receive the following: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT8009, by IV, once a week, ongoing</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT8009, by IV, once a week, ongoing</li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®), by IV, every 2 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BT8009 is an experimental therapy that targets Nectin-4, a protein expressed in some breast cancer cells, and delivers a drug that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Nectin-4 is often expressed in triple negative (ER-, PR-, HER2-) breast cancer. </li> <li class="seamTextUnorderedListItem">Nivolumab (Opdivo®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). It has been approved to treat certain types of cancer. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Targets or mutations: Nectin-4</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04561362' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://investors.bicycletherapeutics.com/news-releases/news-release-details/bicycle-therapeutics-announces-first-patient-dosed-phase-iii-0' target='_blank'>Press Release: BT8009</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bicycletherapeutics.com/programs/' target='_blank'>Bicycle Therapeutics Drug Information Page: BT8009</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/nivolumab' target='_blank'>NCI Drug Dictionary: Nivolumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Nectin' target='_blank'>Wikipedia: Nectin</a> </li></ul>

NEAREST SITE: 1251 miles
Hays Medical Center Dreiling-Schmidt Cancer Institute
Hays,KS

VISITS: 1 visit

PHASE: NA

NCT ID: NCT02302742

A Registry for People with Triple Negative or ER Low, HER2- Breast Cancer or an Inherited BRCA1/2 or Certain Other Mutations

PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations (PROGECT) Scientific Title

Purpose

To learn more about the relationship between genetic mutations and cancer outcomes.

Who is this for?

People with inherited BRCA1/2 mutations or certain other genetic mutations (see list below) and people with stage I, stage II, stage III, or stage IV triple negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer. Full eligibility criteria

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This is a data collection (registry) study. You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 blood test</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER Low breast cancer.</li> <li class="seamTextUnorderedListItem">Studies have found a relationship between triple negative breast cancer and inherited BRCA1 and BRCA2 mutations. </li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, PTEN, P53, and PALB2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02302742' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.net/cancer-types/hereditary-breast-and-ovarian-cancer' target='_blank'>ASCO: Hereditary Breast and Ovarian Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://ww5.komen.org/BreastCancer/InheritedGeneticMutations.html' target='_blank'>Susan G. Komen: Inherited Gene Expressions</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://ghr.nlm.nih.gov/condition/breast-cancer' target='_blank'>NIH Genetics Home Reference: Breast Cancer</a> </li></ul>

NEAREST SITE: 1387 miles
Stephenson Cancer Center - Oncology
Oklahoma City,OK

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05898399

ART6043 Targeted Therapy for Advanced HER2- Breast Cancer with a BRCA Mutation

A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART6043 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of ART6043, an experimental DNA polymerase theta inhibitor, with olaparib (Lynpara®) or talazoparib (Talzenna®) PARP inhibitor compared to a PARP inhibitor alone.

Who is this for?

People with advanced (stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer with a BRCA1/2 mutation who have received treatment with paclitaxel (Taxol®), docetaxel (Taxotere®), or cabazitaxel (Jevtana®) chemotherapy. You must not have received more than 3 lines of chemotherapy including antibody drug conjugates (ADC) for advanced disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ART6043, by mouth</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) or talazoparib (Talzenna®)</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) or talazoparib (Talzenna®)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ART6043 is an experimental targeted therapy called a DNA polymerase theta inhibitor. DNA polymerase theta inhibitors work by blocking the action of DNA polymerase theta, an enzyme that helps cancer cells repair DNA.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynpara®) and talazoparib (Talzenna®) are types of targeted therapy called PARP inhibitors. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps cancer cells repair DNA.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05898399' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.artios.com/pipeline/' target='_blank'>Artios Pharma: ART6043 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/lynparza' target='_blank'>Breastcancer.org: Olaparib (Lynparza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/talzenna' target='_blank'>Breastcancer.org: Talazoparib (Talzenna®)</a> </li></ul>

NEAREST SITE: 1387 miles
University of Oklahoma Health Sciences Center
Oklahoma City,OK

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04550494

PARP Inhibitor Talazoparib for Advanced Breast Cancer that Tests Positive for Certain DNA Repair Mutations

A Pharmacodynamics-Driven Trial of Talazoparib, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage Response Scientific Title

Purpose

To study and compare the anti-cancer activity of giving the PARP inhibitor talazoparib (Talzenna®) to people who have already received a PARP inhibitor to people who have never received a PARP inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer whose disease progressed on at least one standard of care therapy for advanced disease and who have inherited (or whose tumor tests positive for) one of the several targets or mutations listed below. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a PARP inhibitor that is approved to treat people with advanced or metastatic HER2 negative (HER2-) breast cancer and an inherited BRCA1 or BRCA2 mutation, but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ATM, BACH1 (BRIP1), BARD1, BRCA1/2 (tumor or inherited), CDK12, CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCJ, FANCL, FANCM and FANCN</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04550494' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/targeted-cancer-drugs/types/PARP-inhibitors' target='_blank'>Cancer Research UK: PARP Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com/?source=google&HBX_PK=s_talazoparib&skwid=43700051780449266' target='_blank'>Pfizer Oncology Drug Information Page: Talzenna® (Talazoparib)</a> </li></ul>

NEAREST SITE: 1418 miles
University of Nebraska Medical Center
Omaha,NE

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04762979

Alpelisib and Anti-Hormone Therapy for Advanced HR+, HER2- Breast Cancer with a PIK3CA Mutation

A Phase II, Single Arm, Non-randomized Study of Alpelisib (BYL719) in Combination With Continued Endocrine Therapy Following Progression on Endocrine Therapy in Hormone Receptor Positive, HER2 Negative, PIK3CA Mutant Metastatic Breast Cancer Scientific Title

Purpose

To study the anti-cancer activity, safety, and side effects of giving the targeted therapy alpelisib (Piqray®) with an anti-hormone therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) hormone-positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer that tests positive for a PIK3CA mutation. In addition, you must have already received a CDK 4/6 inhibitor, and you must not have received more than two anti-hormone therapies for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Your doctor's choice of anti-hormone therapy, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a targeted therapy called a PI3K inhibitor.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04762979' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/lines-of-therapy-mbc/' target='_blank'>Metastatic Trial Talk: Lines of Therapy for MBC</a> </li></ul>

NEAREST SITE: 1454 miles
The Center for Cancer and Blood Disorders
Fort Worth,TX

VISITS: 1-2 visits every month

PHASE: II

NCT ID: NCT05963984

Samuraciclib CDK7 Inhibitor with Fulvestrant Hormone Therapy for Advanced ER+, HER2- Breast Cancer with TP53 Mutations

An Open-label, Interventional, Multicenter, Randomized, Phase 2 Study of Fulvestrant With or Without Samuraciclib in Participants With Metastatic or Locally Advanced Hormone Receptor (HR) Positive and Human Epidermal Growth Factor Receptor (HER)2-Negative Breast Cancer (BC) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of fulvestrant (Faslodex®) hormone therapy with or without samuraciclib, an experimental CDK7 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with TP53 mutations who are receiving or most recently received an aromatase inhibitor with a CDK4/6 inhibitor. You must not have received more than 1 line of hormone therapy for advanced disease. Full eligibility criteria

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You will be randomly assigned to 1 of 2 groups: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times within 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Samuraciclib, by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, 2 times within 1 month, then monthly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Samuraciclib is an experimental targeted therapy called a CDK7 inhibitor. CDK7 inhibitors may block the CDK7 enzyme that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">If you are premenopausal or perimenopausal, you will also receive a drug that will put you in temporary menopause.</li> <li class="seamTextUnorderedListItem">Targets or mutations: TP53</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05963984' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.carricktherapeutics.com/pipeline/cdk7-inhibitor' target='_blank'>Carrick Therapeutics: Samuraciclib Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li></ul>

NEAREST SITE: 1481 miles
Next Oncology
San Antonio,TX

VISITS: 1 visit every week

PHASE: I-II

NCT ID: NCT06257758

VIO-01 Targeted Therapy for Advanced HER2- Breast Cancer with HRR or HRD Mutations

A Phase 1/2 Study of VIO-01 in Participants With Recurrent Solid Tumors Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of VIO-01, an experimental targeted therapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer who have received 0-1 lines of therapy for advanced disease. You must have a BRCA1, BRCA2, PALB2, ATM, ATR, CHEK2, FANCA, MLH1, MRE11A, NBN, RAD51C, CDK12, or other homologous recombination repair (HRR) or homologous recombination deficiency (HRD) mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VIO-01, by IV, weekly</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VIO-01 is an experimental targeted therapy called a DNA decoy drug. VIO-01 may prevent tumor cells from repairing tumor DNA which helps cancer grow.</li> <li class="seamTextUnorderedListItem">BRCA1, BRCA2, PALB2, ATM, ATR, CHEK2, FANCA, MLH1, MRE11A, NBN, RAD51C, CDK12, are types of homologous recombination repair (HRR) or homologous recombination deficiency (HRD) mutations.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06257758' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://valeriotx.com/our-science/#pipeline' target='_blank'>Valerio Therapeutics: VIO-01 Drug Information Page</a> </li></ul>

NEAREST SITE: 1643 miles
The University of Texas MD Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05514717

XMT-2056 ADC for Advanced HER2+ or HER2 Mutated Breast Cancer

A Phase 1, First in Human, Dose Escalation and Expansion, Multicenter Study of XMT-2056 in Participants With Advanced/Recurrent Solid Tumors That Express HER2 Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of XMT-2056, an experimental antibody drug conjugate (ADC).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer or breast cancer with a HER2 mutation who have received standard treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XMT-2056, by IV</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XMT-2056 is an experimental antibody drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate (ADC) is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">XMT-2056's antibody targets HER2, a protein that is expressed by some breast cancer cells, and it delivers an anti-cancer drug called Immunosynthen.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HER2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05514717' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mersana.com/pipeline/overview/' target='_blank'>Mersana Therapeutics Drug Information Page: XMT-2056</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mersana.com/our-technology-platforms/about-adcs/' target='_blank'>Mersana Therapeutics: About ADCs</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mersana.com/our-technology-platforms/immunosynthen/' target='_blank'>Mersana Therapeutics: Immunosynthen</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li></ul>

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT06130254

Adagrasib Targeted Therapy for Advanced Breast Cancer with KRAS G12C Mutations

Phase Ib Trial of the KRAS G12C Inhibitor Adagrasib (MRTX849) in Combination With the PARP Inhibitor Olaparib in Patients With KRAS G12C Mutated Advanced Solid Tumors, With a Focus on Gynecological, Breast, Pancreatic and KEAP1 Mutated Non-small Cell Lung Cancers Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of adagrasib (MRTX849), an experimental KRAS G12C inhibitor, with olaparib (Lynparza®) PARP inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer with a KRAS G12C mutation who have received at least 1 line of therapy for advanced disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Adagrasib (MRTX849), by mouth, daily</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Adagrasib (MRTX849) is an experimental targeted therapy called a KRAS G12C inhibitor. Blocking KRAS G12C may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06130254' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mirati.com/science/pipeline/' target='_blank'>Mirati Therapeutics: Adagrasib (MRTX849) Drug Information Page</a> </li></ul>

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05243641

Targeted Therapy for Metastatic HER2- Breast Cancer with Abnormal HER-family and c-Met Signaling Activity

Neratinib and Capmatinib Combination (Phase Ib/II) in Metastatic Breast Cancer and Inflammatory Breast Cancer Patients With Abnormal HER2 and c-Met Pathway Activity as Measured by the CELsignia Signaling Analysis Test Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of neratinib (Nerlynx®) anti-HER2 targeted therapy and capmatinib (Tabrecta®) MET/c-MET inhibitor.

Who is this for?

Phase Ib: People with metastatic (stage IV) breast cancer with any ER, PR, and HER2 status who have received 1-6 lines of therapy for metastatic disease. Phase IIb: People with metastatic (stage IV) HER2 negative (HER2-) breast cancer with abnormal HER-family and c-Met signaling activity who have received 1-6 lines of therapy for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth</li> <li class="seamTextUnorderedListItem">Capmatinib (Tabrecta®), by mouth</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is a type of anti-HER2 targeted therapy used to treat early-stage and metastatic HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Capmatinib (Tabrecta®) is a type of targeted therapy called a MET/c-Met inhibitor. Blocking MET/c-Met may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Your HER-family and c-Met signaling activity will be determined by CELsignia MP Test results.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with inflammatory breast cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HER-family, c-Met</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05243641' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/nerlynx' target='_blank'>Breastcancer.org: Neratinib (Nerlynx®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/drugs-supplements/capmatinib-oral-route/side-effects/drg-20488162?p=1' target='_blank'>Mayo Clinic: Capmatinib (Tabrecta®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/patients-family/diagnosis-treatment/clinical-trials/clinical-trials-index/clinical-trials-detail.ID2020-0198.html' target='_blank'>MD Anderson Cancer Center Trial Information Page</a> </li></ul>

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: I

NCT ID: NCT05092373

Tumor Treating Fields Device for Advanced Breast Cancer

Phase I Study of Tumor Treating Fields (TTF) in Combination With Cabozantinib, or With Atezolizumab and Nab-Paclitaxel in Patients With Advanced Solid Tumors Involving the Abdomen or Thorax Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of Tumor Treating Fields (TTF), an experimental wearable device, with targeted therapy or chemotherapy and immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer. Full eligibility criteria

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You will be assigned to 1 of 2 groups based on your type of cancer: Group 1: TTF with Targeted Therapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor Treating Fields (TTF), daily</li> <li class="seamTextUnorderedListItem">Cabozantinib (Cabometyx® or Cometriq®), by mouth, daily</li> </ul> Group 2: TTF with Chemotherapy and Immunotherapy <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor Treating Fields (TTF), daily</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®), by IV, weekly, 3 weeks on, 1 week off</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®), by IV, every 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tumor Treating Fields (TTF) consists of experimental wearable devices that use electrical fields at different frequencies to stop the growth of tumor cells by interrupting cancer cells' ability to divide.</li> <li class="seamTextUnorderedListItem">Cabozantinib (Cabometyx® or Cometriq®) is a type of targeted therapy called a tyrosine kinase inhibitor. Tyrosine kinase inhibitors work by blocking proteins that signal cancer cells to multiply, which may help keep cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Atezolizumab (Tecentriq®) is a type of immunotherapy called a PD-L1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-L1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Nab-paclitaxel (Abraxane®) is a type of chemotherapy drug.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05092373' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.verywellhealth.com/tumor-treating-fields-ttf-4584149' target='_blank'>Verywell Health: Tumor Treating Fields (TTF)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a616037.html' target='_blank'>MedlinePlus: Cabozantinib (Cabometyx® or Cometriq®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/abraxane' target='_blank'>Breastcancer.org: Nab-paclitaxel (Abraxane®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/tecentriq' target='_blank'>Breastcancer.org: Atezolizumab (Tecentriq®)</a> </li></ul>

NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT04771520

Targeted Therapy Avapritinib for Advanced Breast Cancer with a CKIT or PDGFRA Mutation

Phase 2 Study of Avapritinib in Patients With CKIT or PDGFRA Mutation-Positive Malignant Solid Tumors Scientific Title

Purpose

To study the safety, side effects and anti-cancer activity of the targeted therapy avapritinib (Ayvakit).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer whose tumor tests positive for a CKIT or a PDGFRA mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Avapritinib (Ayvakit), by mouth, daily, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Avapritinib (Ayvakit) is an experimental type of targeted therapy called a tyrosine kinase inhibitor. It works by targeting certain CKIT and PDGFRA kinases.</li> <li class="seamTextUnorderedListItem">Avapritinib (Ayvakit) is approved for use in some people with advanced GIST cancer, but its use in breast cancer is considered experimental. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancers that test positive for CKIT or PDGFRA.</li> <li class="seamTextUnorderedListItem">Targets or mutations: CKIT, PDGFRA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04771520' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/drugs/avapritinib' target='_blank'>NCI A to Z List of Cancer Drugs: Avapritinib (Ayvakit)</a> </li><li class='seamTextUnorderedListItem'><a href='https://ayvakit.com' target='_blank'>Blueprint Medicines Drug Information Page: Ayvakit (Avapritinib)</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopost.com/issues/january-25-2020/fda-approves-avapritinib-for-pdgfra-mutated-gastrointestinal-stromal-tumor/' target='_blank'>The ASCO Post: FDA Approves Avapritinib for the Treatment of PDGFRA-Mutated Gastrointestinal Stromal Tumor</a> </li></ul>

NEAREST SITE: 1678 miles
University of Wisconsin Carbone Cancer Center
Madison,WI

VISITS: 1 visit every 3 to 4 weeks, ongoing

PHASE: NA

NCT ID: NCT04174352

Imaging to Personalize Amount of Tamoxifen in Advanced, ER+, HER2- Breast Cancer With a ESR1 Mutation

A Pilot Study of FES Imaging to Optimize Tamoxifen Dose for Metastatic Breast Cancer Patients With ESR1 Mutations Scientific Title

Purpose

To study if FES-PET/CT scans can help find a personalized dose of tamoxifen (Nolvadex®).

Who is this for?

People with advanced (some stage III) or metastatic (stage IV), estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer that tests positive for a ESR1 mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">FES PET/CT scan, every 3 to 4 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is an anti-estrogen therapy used to treat hormone-sensitive breast cancer.</li> <li class="seamTextUnorderedListItem">ESR1 mutations in breast cancer may affect how well tamoxifen works against tumor cells. </li> <li class="seamTextUnorderedListItem">Tracers are chemicals that are used to find cancer cells in the body during a PET scan. The imaging trial will use the tracer fluoroestradiol (FES)--it finds estrogen receptors in breast tumors. </li> <li class="seamTextUnorderedListItem">The FES tracer may also show how tamoxifen is affecting your tumors. Researchers may use this information to increase your dose of tamoxifen.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ESR1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04174352' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.net/research-and-advocacy/asco-care-and-treatment-recommendations-patients/hormonal-therapy-metastatic-breast-cancer' target='_blank'>ASCO Cancer.net: Hormonal Therapy for Metastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal/serms/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/more-effective-therapies-needed-for-patients-with-esr1mutated-breast-cancer' target='_blank'>Targeted Oncology: More Effective Therapies Needed For Patients With ESR1-Mutated Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.karger.com/Article/FullText/481428' target='_blank'>Journal Article: Are We Ready to Use ESR1 Mutations in Clinical Practice</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ijcem.com/files/ijcem0076055.pdf' target='_blank'>Journal Article: The Role of PET Imaging Probes for Early Monitoring the Response to Tamoxifen</a> </li></ul>

NEAREST SITE: 1832 miles
Froedtert Hospital & Medical College of Wisconsin
Milwaukee,WI

VISITS: 1 visit a week for 5 months

PHASE: II

NCT ID: NCT04243616

Checkpoint Inhibitor Cemiplimab and Chemotherapy Before Surgery in Women with Stage I-III HER2- Breast Cancer That is PD-1/PD-L1 Positive

Phase II Study of PD-1 Inhibition With Cemiplimab in Locally Advanced Hormone Receptor (HR) Positive HER2 Negative or Triple-Negative Breast Cancer Patients Undergoing Standard Neoadjuvant Chemotherapy Scientific Title

Purpose

To study the anti-cancer activity of combining the immunotherapy cemiplimab (Libtayo®) with chemotherapy when they are given together before surgery (neoadjuvant therapy).

Who is this for?

Women with stage I, stage II, or stage III HER2 negative (HER2-) breast cancer planning to have chemotherapy before surgery (neoadjuvant chemotherapy) whose tumor tests positive for PD-1/PD-L1. Full eligibility criteria

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You will receive the following before surgery: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cemiplimab (Libtayo®), by IV, every 3 weeks, for 1.5 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every week, for 3 months</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) (optional; as determined by your doctor), by IV, every 3 weeks, for 3 months</li> </ul> followed by <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Doxorubicin (Adriamycin®) and Cyclophosphamide (Cytoxan®), by IV, every 2 weeks, for 2 months</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cemiplimab (Libtayo®) is a type of immunotherapy called a checkpoint inhibitor. It gets the immune system to go after cancer cells by blocking a protein called PD-1 (programmed cell death 1). </li> <li class="seamTextUnorderedListItem">Cemiplimab has been approved to treat certain types of cancer, but its use in breast cancer is considered experimental.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04243616' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.libtayo.com/?utm_source=google&utm_medium=cpc&utm_campaign=BrandedGeneral&utm_content=Cemiplimab&gclid=Cj0KCQjw7sz6BRDYARIsAPHzrNKtR1hl8qa7fjF-zydhegx9TDEoFUKDu-9FaUiBalzV8Xpjl8Xk6C0aArWHEALw_wcB' target='_blank'>Regeneron Pharmaceuticals Drug Information Page: Libtayo® (Cemiplimab)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/immune-checkpoint-inhibitor' target='_blank'>NCI Dictionary of Cancer Terms: Checkpoint Inhibitor</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancertherapyadvisor.com/home/cancer-topics/breast-cancer/breast-cancer-addition-immunotherapy-standard-neoadjuvant-chemotherapy/' target='_blank'>Cancer Therapy Advisor: Addition of Immunotherapy to Standard Neoadjuvant Chemotherapy Yields Promising Results in HER2-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.lbbc.org/learn/treatments-and-research/chemotherapy/common-chemotherapy-regimens/ac-t-doxorubicin-and' target='_blank'>Living Beyond Breast Cancer: AC-T Regimen</a> </li></ul>

NEAREST SITE: 2013 miles
University of Alabama at Birmingham
Birmingham,AL

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT04711824

Targeted Therapy, Radiation, Chemotherapy, and Immunotherapy for Metastatic Triple Negative or HER2-, BRCA Mutated Breast Cancer with Brain Metastases

Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (Olaparib) Followed by Adjuvant Combination of Durvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of olaparib (Lynparza®) PARP inhibitor, stereotactic radiosurgery, chemotherapy, and durvalumab (Imfinzi®) PD-L1 inhibitor.

Who is this for?

Postmenopausal women or men with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer or HER2 negative (HER2-) breast cancer that has spread to the brain (brain metastasis). If you have HER2- breast cancer, you must also have a germline (inherited) or somatic (tumor) BRCA mutation. You must have at least 1 brain tumor that has not been treated with radiation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily for 1 month</li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS), 1-5 times</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy: Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), eribulin (Halaven®), carboplatin (Paraplatin®), cisplatin (Platinol®), capecitabine (Xeloda®), or gemcitabine (Gemzar®)</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), eribulin (Halaven®), carboplatin (Paraplatin®), cisplatin (Platinol®), capecitabine (Xeloda®), or gemcitabine (Gemzar®) are chemotherapy drugs that slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-L1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04711824' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/lynparza' target='_blank'>Breastcancer.org: Olaparib (Lynparza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/stereotactic-radiosurgery/about/pac-20384526' target='_blank'>Mayo Clinic: Stereotactic Radiosurgery</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617030.html' target='_blank'>MedlinePlus: Durvalumab (Imfinzi®)</a> </li></ul>

NEAREST SITE: 2139 miles
Emory Winship Cancer Institute
Atlanta,GA

VISITS: Number of visits unavailable

PHASE: I-II

NCT ID: NCT05735080

INX-315 CDK2 Inhibitor for Advanced ER+, HER2- or CCNE1 Amplified Breast Cancer

A Phase 1/2, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of INX-315 in Patients With Advanced Cancer Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of INX-315, an experimental CDK2 inhibitor, alone or with other anti-cancer therapies.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer who have received treatment with a CDK4/6 inhibitor or CCNE1 amplified breast cancer with no standard treatment options available. Full eligibility criteria

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You will be assigned to 1 of 2 groups based on your type of cancer: Group 1: CCNE1 Amplified Breast Cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INX-315, by mouth</li> </ul> Group 2: ER Positive, HER2 Negative Breast Cancer <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INX-315, by mouth</li> <li class="seamTextUnorderedListItem">Selective estrogen receptor degrader (SERD) hormone therapy (standard of care)</li> <li class="seamTextUnorderedListItem">CDK 4/6 inhibitor (standard of care)</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">INX-315 is an experimental targeted therapy called a CDK2 inhibitor. CDK2 inhibitors block the enzyme/protein CDK2 that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Selective estrogen receptor degraders (SERD) are a type of hormone therapy that bind to and break down estrogen receptors. </li> <li class="seamTextUnorderedListItem">CDK4/6 inhibitors are a type of targeted therapy that block two proteins, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: CCNE1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05735080' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://incyclixbio.com/our-science/' target='_blank'>Incyclix Bio Drug Information Page: INX-315</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy and SERDs</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/cdk-inhibitor-updates/' target='_blank'>Metastatic Trial Talk: The Latest Research on CDK 4/6 Inhibitors</a> </li></ul>

NEAREST SITE: 2383 miles
Mayo Clinic in Florida
Jacksonville,FL

VISITS: 1 visit

PHASE: NA

NCT ID: NCT06349642

Registry to Predict Response to Immune Checkpoint Inhibitors for People with Stage I-IV Breast Cancer

Observational Basket Study to Predict Response to Immune Checkpoint Inhibitors Across Solid Tumors Using a Live Tumor Diagnostic Platform (CYBRID-04) Scientific Title

Purpose

To create a registry to predict response to treatment with immune checkpoint inhibitors.

Who is this for?

People with stage I, stage II, stage III, or stage IV (metastatic) triple negative (ER-, PR-, HER2-) breast cancer or breast cancer with TMB, MSI-H, or dMMR mutations who are planning to receive pembrolizumab (Keytruda®) or dostarlimab (Jemperli®). If you have stage I, stage II, or stage III breast cancer, you must have not yet received treatment. Full eligibility criteria

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You will provide the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Biopsy sample</li> <li class="seamTextUnorderedListItem">Blood sample</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Immunotherapy may help the body's immune system attack cancer and may reduce the ability of tumor cells to grow and spread.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) and dostarlimab (Jemperli®) are types of immunotherapy called PD-1 inhibitors, which are a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">MSI-H and dMMR mutations include MLH1, MSH2, MSH6, and PMS2.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: TMB, MSI-H, dMMR, MLH1, MSH2, MSH6, PMS2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06349642' target='_blank'>ClinicalTrials.gov</a> </li></ul>

NEAREST SITE: 2385 miles
Duke University Medical Center
Durham,NC

VISITS: 6 visits over 2 months

PHASE: I

NCT ID: NCT04270149

ESR1 Peptide Vaccine for Stage II-III, ER+ Breast Cancer That Tests Positive for HLA

A Phase I Study of Cancer Peptides Plus GM-CSF and Adjuvant Following Completion of Prescribed Systemic Therapy of Estrogen Receptor Positive Breast Cancer Scientific Title

Purpose

To study the safety and the effects on the immune system of receiving a vaccine along with two other immunotherapies.

Who is this for?

People with stage II or stage III estrogen receptor positive (ER+) breast cancer whose tumor was at least 5 cm and tested positive for HLA, and who are within two years of having completed treatment. Full eligibility criteria

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You will receive the following 6 times over 7 weeks: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ESR1 peptide vaccine, by injection</li> <li class="seamTextUnorderedListItem">Montanide, by injection</li> <li class="seamTextUnorderedListItem">GM-CSF, by injection</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The experimental vaccine used in this trial is an ESR1 peptide vaccine.</li> <li class="seamTextUnorderedListItem">Montanide and GM-CSF are immunotherapies researchers believe will make the ESR1 peptide vaccine more effective.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HLA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04270149' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.dukecancerinstitute.org/clinical-trial/pro00104868' target='_blank'>Duke Cancer Institute Study Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/montanide-isa-720' target='_blank'>NCI Drug Dictionary: Montanide</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/gm-csf' target='_blank'>NCI Dictionary of Cancer Terms: GM-CSF</a> </li><li class='seamTextUnorderedListItem'><a href='https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.3135' target='_blank'>ASCO Abstract: ESR1 Mutations Provide Novel Targets for Breast Cancer Immunotherapy</a> </li></ul>

NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT05694364

PRGN-3007 CAR T Cell Therapy for Advanced Triple Negative, ROR-1 Positive Breast Cancer

A Phase 1/1b Dose Escalation/Dose Expansion Study of PRGN-3007 UltraCAR-T Cells in Patients With Advanced Hematologic and Solid Tumor Malignancies Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of PRGN-3007 CAR T-cells, an experimental immunotherapy.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-), ROR-1 positive breast cancer. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRGN-3007 CAR T-cells</li> </ul> Please contact research site for treatment schedule
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">PRGN-3007 CAR-T or CAR T cells are an experimental personalized immunotherapy made from your white blood cells. The white blood cells are removed from your body and then modified with chimeric antigen receptors (CARs) so they can attack specific proteins. These white blood cells are then infused into your body.</li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy used in this study trains the immune system to attack cancer cells that test positive for the protein ROR-1.</li> <li class="seamTextUnorderedListItem">Before you receive PRGN-3007 T-cells, you will be given the chemotherapy drug cyclophosphamide (Cytoxan®) to prepare your immune system to receive the immunotherapy.</li> <li class="seamTextUnorderedListItem">Leukapheresis is a procedure to collect your white blood cells to make your personalized CAR T-cell therapy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ROR-1</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05694364' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://precigen.com/pipeline/' target='_blank'>Precigen: PRGN-3007 Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/cytoxan' target='_blank'>Breastcancer.org: Cyclophosphamide (Cytoxan®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapies/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies for MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/immunotherapy/car-t-cell1.html' target='_blank'>American Cancer Society: CAR T-Cell Therapy</a> </li></ul>

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: Requires hospitalization for 3-4 weeks

PHASE: I

NCT ID: NCT06253520

T Cell Therapy with a Vaccine for Metastatic Breast Cancer with KRAS Mutations

A Phase Ib Clinical Trial to Evaluate the Administration of Autologous T-cells Genetically Engineered to Express Receptors Reactive Against KRAS Mutations in Conjunction With a Vaccine Directed Against These Antigens in Participants With Metastatic Cancer Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of an experimental T cell therapy using a person's own modified white blood cells with an experimental vaccine.

Who is this for?

People with stage IV (metastatic) breast cancer with a KRAS mutation who have received at least 2 lines of therapy. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®), by IV, 5 days</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, 2 days</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aldesleukin, by IV, 1-4 days</li> <li class="seamTextUnorderedListItem">T cells, by IV, 1 time</li> <li class="seamTextUnorderedListItem">Vaccine, by injection, 3-4 times</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Many cancer cells produce substances (antigens) that are unique to each cancer and stimulate the body's immune responses.</li> <li class="seamTextUnorderedListItem">Taking disease-fighting white blood cells (T cells) from a person, changing those cells so they will target the specific proteins (antigens) from the cancer cells, and returning them to that person's blood is a form of gene therapy.</li> <li class="seamTextUnorderedListItem">A vaccine may help these modified white cells work better.</li> <li class="seamTextUnorderedListItem">Leukapheresis is when blood is removed from the body, white blood cells are separated, and the remaining blood is returned to the body.</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®) and cyclophosphamide (Cytoxan®) are chemotherapy drugs that make the T cells more effective in fighting cancer cells.</li> <li class="seamTextUnorderedListItem">Aldesleukin is a drug that stimulates the growth and development of T cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06253520' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/adoptive-cell-therapy-2-2/' target='_blank'>Metastatic Trial Talk: Adoptive Cell Therapies: A Type of Immunotherapy for MBC</a> </li></ul>

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: Hospital stay for at least 1 week; follow-up visits for 2 years

PHASE: I-II

NCT ID: NCT02830724

CAR T-Cell Immunotherapy for Metastatic Breast Cancer That Tests Positive for CD70

A Phase I/II Study Administering Peripheral Blood Lymphocytes Transduced With a CD70-Binding Chimeric Antigen Receptor to Patients With CD70 Expressing Cancers Scientific Title

Purpose

To study the safety and effects (good and bad) of using a new type of CAR T-cell immunotherapy.

Who is this for?

People with metastatic (stage IV) breast cancer that tests positive for CD70 who have already received at least one standard therapy. Full eligibility criteria

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You will receive the following: Hospital stay (at least 1-week): <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis (blood draw for the collection of cells)</li> <li class="seamTextUnorderedListItem">Cyclophosphamide, by IV, once a day, for 2 days</li> <li class="seamTextUnorderedListItem">Fludarabine, by IV, once a day, for 5 days</li> <li class="seamTextUnorderedListItem">Aldesleukin, by IV, 3 times a day, for 3 days</li> <li class="seamTextUnorderedListItem">Anti-hCD70 CAR T-cells, by IV, one time</li> </ul> Post-hospital stay: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Antibiotic for 6 months</li> <li class="seamTextUnorderedListItem">Repeat Leukapheresis (blood draw for the collection of cells)</li> <li class="seamTextUnorderedListItem">1-2 day hospital visits (for lab tests, imaging studies, and a physical exam), every 1-3 months for the 1st year after treatment, every 6 months for the 2nd year, and then as determined by your doctor</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CAR T-cell is a personalized immunotherapy made from your white blood cells. </li> <li class="seamTextUnorderedListItem">After your blood cells are removed, they are modified with chimeric antigen receptors (CARs) so they can attack specific proteins. </li> <li class="seamTextUnorderedListItem">The CAR T-cells are then infused back into you while you are hospitalized. </li> <li class="seamTextUnorderedListItem">The CAR T-cell therapy used in this study is designed to get the immune system to see and kill cancer cells that are CD70+. </li> <li class="seamTextUnorderedListItem">Along with the CAR-T immunotherapy, you will receive the chemotherapy drugs fludarabine and cyclophosphamide. These drugs are given to deplete the lymph cells. </li> <li class="seamTextUnorderedListItem">You will also receive aldesleukin, a drug that stimulates the growth and development of T cells.</li> <li class="seamTextUnorderedListItem">Targets or mutations: CD70</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02830724' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.drsusanloveresearch.org/videos/chimeric-antigen-receptor-t-cell-car-t-therapy' target='_blank'>Dr Susan Love Research Foundation: CAR-T Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ncbi.nlm.nih.gov/pubmed/25368676' target='_blank'>Journal Article Abstract: CD70, A Potential Target in Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/search?contains=false&q=Aldesleukin' target='_blank'>NCI Drug Dictionary: Aldesleukin</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/what-is-car-t-therapy/' target='_blank'>Metastatic Trial Talk: What is CAR-T Therapy?</a> </li></ul>

NEAREST SITE: 2432 miles
National Institutes of Health Clinical Center
Bethesda,MD

VISITS: Requires hospitalization

PHASE: I

NCT ID: NCT05035407

Gene Therapy for KK-LC-1 Positive Metastatic Breast Cancer with a HLA Mutation

A Phase I Trial of T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung and Other KK-LC-1 Positive Epithelial Cancers Scientific Title

Purpose

To study the safety and best dose of gene therapy with KK-LC-1 TCR T cells, an experimental immunotherapy.

Who is this for?

People with KK-LC-1 positive (KK-LC-1+) metastatic (stage IV) breast cancer with a HLA mutation that has progressed on standard treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis procedure</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®), by IV, daily, 2 days</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®), by IV, daily, 5 days</li> <li class="seamTextUnorderedListItem">KK-LC-1 TCR T cells, by injection, 1 session</li> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2), by IV, daily, 4 days</li> </ul> Additional Procedures <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Requires hospitalization for 3-4 weeks</li> <li class="seamTextUnorderedListItem">May require follow-up visits every 3-6 months for up to 5 years</li> <li class="seamTextUnorderedListItem">May require questionnaires for up to 15 years</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Gene therapy is a treatment that inserts genetic material (DNA or RNA) directly into your cells to prevent or fight disease.</li> <li class="seamTextUnorderedListItem">Gene therapy with KK-LC-1 T cell receptor (TCR) T cells is an experimental type of immunotherapy that trains the immune system to attack KK-LC-1 positive cancer cells.</li> <li class="seamTextUnorderedListItem">About 75% of triple negative breast cancer is KK-LC-1 positive.</li> <li class="seamTextUnorderedListItem">Leukapheresis is the removal of blood by a machine to collect specific immune cells called T cells that will be modified to target cancer cells.</li> <li class="seamTextUnorderedListItem">The T cells will be grown in a lab, modified, and given back to you through an injection into your tumor.</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and fludarabine (Fludara®) are chemotherapy drugs. The main purpose of chemotherapy drugs in this trial is to make the T cells more effective in fighting cancer cells.</li> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2) may help the T cells live longer in your body.</li> <li class="seamTextUnorderedListItem">Targets or mutations: HLA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05035407' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/genetics/understanding/therapy/genetherapy/#:~:text=Gene%20therapy%20is%20a%20medical,of%20using%20drugs%20or%20surgery.' target='_blank'>MedlinePlus: What is Gene Therapy?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/t-cell-transfer-therapy' target='_blank'>National Cancer Institute: T Cell Transfer Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/s41598-018-24514-9' target='_blank'>Journal Article: KK-LC-1 Positive Cancer Cells</a> </li></ul>

NEAREST SITE: 2452 miles
University of Maryland Greenebaum Comprehensive Cancer Center
Baltimore,MD

VISITS: 1 visit every 2 weeks

PHASE: I

NCT ID: NCT05627960

AG01 Targeted Therapy for Advanced HER2-/HER2 Low Breast Cancer That Expresses GP88

FIH Phase 1A /1B Study of AG01 Antibody Against Progranulin/GP88 in Advanced Solid Tumor Malignancies With Expansion Cohorts in Advanced Triple Negative Breast Ca, Hormone Resistant Breast Ca, Non Small Cell Lung Cancer and Mesothelioma Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of AG01, an experimental PGRN/GP88 inhibitor.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) or HER2 low breast cancer that expresses GP88. You must have received standard treatment. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AG01, by IV, every 2 weeks</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AG01 is an experimental targeted therapy called a PGRN/GP88 inhibitor. Blocking PGRN/GP88 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: GP88</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05627960' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.abstractsonline.com/pp8/#!/10462/presentation/1702' target='_blank'>SABCS 2021 Abstract: AG01 Inhibits Growth of Triple Negative Breast Cancer Cells</a> </li><li class='seamTextUnorderedListItem'><a href='https://pubmed.ncbi.nlm.nih.gov/33616772/' target='_blank'>Journal Article: AG01 Inhibits Triple Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy' target='_blank'>Breastcancer.org: Targeted Therapy</a> </li></ul>

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge,NJ

VISITS: 1-4 visits within 1 month

PHASE: II

NCT ID: NCT05966584

Benralizumab to Prevent Rashes During Treatment with Alpelisib for Metastatic ER+, HER2- Breast Cancer with PIK3CA Mutations

RETENTION: An Open-Label Phase 2 Trial of InteRlEukin (5) InhibiTion for the prEveNTION of Alpelisib Rash in Metastatic PIK3CA-mutant Hormone-Receptor Positive Breast Cancer Scientific Title

Purpose

To study the ability of benralizumab to prevent rashes during treatment with alpelisib (Piqray®) PI3K inhibitor and hormone therapy.

Who is this for?

Postmenopausal women and men with metastatic (stage IV) estrogen receptor positive (ER+), HER2 negative (HER2-) breast cancer with PIK3CA mutations who are planning to receive hormone therapy. You must not have received more than 2 lines of hormone therapy for metastatic disease. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Benralizumab, by injection, 1 time</li> </ul> with standard of care therapy: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), 3 times within 1 month, then monthly, or an aromatase inhibitor</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Skin rash is a common side effect of alpelisib (Piqray®).</li> <li class="seamTextUnorderedListItem">Researchers think adding benralizumab to standard of care therapy may prevent rashes.</li> <li class="seamTextUnorderedListItem">Benralizumab is an immunotherapy that is used to treat diseases such as asthma. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">In this trial, alpelisib (Piqray®), fulvestrant (Faslodex®), and aromatase inhibitors are standard of care therapies.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor degrader (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), letrozole (Femara®), and exemestane (Aromasin®) are types of hormone therapy called aromatase inhibitors. Aromatase inhibitors block some production of estrogen that helps cancer grow.</li> <li class="seamTextUnorderedListItem">Targets or mutations: PIK3CA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05966584' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a618002.html#:~:text=Benralizumab%20injection%20is%20used%20along,with%20their%20current%20asthma%20medication.' target='_blank'>MedlinePlus: Benralizumab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy' target='_blank'>Breastcancer.org: Hormone Therapy</a> </li></ul>

NEAREST SITE: 2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ

VISITS: 2 visits within 3 months

PHASE: II

NCT ID: NCT05203445

Neoadjuvant Targeted Therapy and Immunotherapy for Stage I-III HER2- Breast Cancer

Phase II of Neoadjuvant Olaparib in Combination With Pembrolizumab in Patients With Triple Negative Breast Cancer (TNBC) or Hormone Receptor-positive HER2-negative Breast Cancer and Germline Mutations in DNA Damage Repair Genes Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of olaparib (Lynparza®) PARP inhibitor with pembrolizumab (Keytruda®) immunotherapy before surgery (neoadjuvant).

Who is this for?

People with stage I, stage II, or some stage III HER2 negative (HER2-) breast cancer who have an inherited BRCA1, BRCA2, PALB2, RAD51C, or RAD51D mutation and have not yet received surgery. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, twice within 3 months</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily for 3 months</li> </ul> possibly followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Chemotherapy</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">If your tumor does not grow, you will also receive chemotherapy.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, PALB2, RAD51C, RAD51D</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05203445' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy/keytruda' target='_blank'>Breastcancer.org: Pembrolizumab (Keytruda®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/lynparza' target='_blank'>Breastcancer.org: Olaparib (Lynparza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immune-checkpoint-inhibitor/' target='_blank'>Metastatic Trial Talk: Update on Immunotherapy for MBC: Immune Checkpoint Inhibitors</a> </li></ul>

NEAREST SITE: 2548 miles
Rutgers Cancer Institute of New Jersey
New Brunswick,NJ

VISITS: May require hospitalization

PHASE: I

NCT ID: NCT05483491

KK-LC-1 TCR T Cell Therapy for Metastatic Triple Negative, KK-LC-1 Positive Breast Cancer with a HLA Mutation

T Cell Receptor Gene Therapy Targeting KK-LC-1 for Gastric, Breast, Cervical, Lung, and Other KK-LC-1 Positive Cancers Scientific Title

Purpose

To study the safety, best dose, effects (good and bad), and anti-cancer activity of KK-LC-1 TCR T cells, an experimental immunotherapy.

Who is this for?

People with metastatic (stage IV) triple negative (ER-, PR-, HER2-), KK-LC-1 positive (KK-LC-1+) breast cancer with a HLA mutation who have no standard treatment options available. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">Fludarabine (Fludara®)</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KK-LC-1 TCR T cells, by IV, 1 time</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2), by IV, daily for 1-2 days</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">KK-LC-1 TCR T cells are an experimental immunotherapy that train the immune system to attack KK-LC-1 positive cancer cells.</li> <li class="seamTextUnorderedListItem">The T cells will be grown in a lab, modified, and given back to you through an infusion.</li> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®) and fludarabine (Fludara®) are chemotherapy drugs. The main purpose of chemotherapy drugs in this trial is to make the T cells more effective in fighting cancer cells.</li> <li class="seamTextUnorderedListItem">Aldesleukin (IL-2) may help the T cells live longer in your body.</li> <li class="seamTextUnorderedListItem">KK-LC-1 is an abnormal protein that is expressed by certain types of cancer. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: KK-LC-1, HLA</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05483491' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://moffitt.org/treatments/immunotherapy/cellular-immunotherapy/tcr-therapy/' target='_blank'>Moffitt Cancer Center: T-Cell Receptor (TCR) Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/about-cancer/treatment/types/immunotherapy/t-cell-transfer-therapy' target='_blank'>Journal Article: KK-LC-1 Positive Cancer Cells</a> </li></ul>

NEAREST SITE: 2549 miles
Rutgers Cancer Institute of New Jersey
New Brunswick,NJ

VISITS: Please contact research site

PHASE: II

NCT ID: NCT03428802

Keytruda for Advanced Breast Cancer in People With a BRCA1/2 Tumor Mutation

A Basket Trial of Pembrolizumab in Patients With Advanced Solid Tumors and Genomic Instability Scientific Title

Purpose

To study the effects (good and bad) of using an immunotherapy drug to treat cancer that has spread outside the breast to nearby tissue or lymph nodes or to other parts of the body.

Who is this for?

People with advanced (some stage III) or metastatic (stage IV) breast cancer who have been tested for and found to have a BRCA 1 or BRCA 2 tumor mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, ongoing</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The immunotherapy drug is pembrolizumab (Keytruda®). </li> <li class="seamTextUnorderedListItem">Keytruda® is a type of immunotherapy drug called a PD-1 inhibitor. It gets the immune system to go after cancer cells by blocking a protein called programmed cell death (PD-1). </li> <li class="seamTextUnorderedListItem">Keytruda® is currently approved to treat certain types of cancers.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancers.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03428802' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.ascopost.com/issues/july-10-2017/pembrolizumab-moving-forward-in-triple-negative-breast-cancer/' target='_blank'>ASCO: Keytruda for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.keytruda.com' target='_blank'>Merck Oncology Information Page: Keytruda</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.curetoday.com/articles/parp-inhibitor-may-prolong-survival-in-metastatic-brcapositive-breast-cancer' target='_blank'>Cure Today: Parp Inhibitor May Prolong Survival</a> </li></ul>

NEAREST SITE: 2567 miles
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York,NY

VISITS: Number of visits unavailable

PHASE: II

NCT ID: NCT06058988

Trastuzumab Deruxtecan Antibody Drug Conjugate for Metastatic HER2 Positive, Low, or Mutated Breast Cancer with Brain Metastases

Window of Opportunity Assessment of [Fam-]Trastuzumab DERuxtecan-nxki (T-DXd) Brain Tumor Penetration and Efficacy (WOnDER-BT) Scientific Title

Purpose

To study the safety, effects, and anti-cancer activity of trastuzumab deruxtecan (T-DXd, Enhertu®) antibody-drug conjugate (ADC) for people with brain metastases.

Who is this for?

People with metastatic (stage IV) HER2 positive (HER2+), HER2 low, or HER2 mutated breast cancer that has spread to the brain (brain metastasis) and are planning to receive brain surgery. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®), by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC).</li> <li class="seamTextUnorderedListItem">An antibody-drug conjugate is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li> <li class="seamTextUnorderedListItem">Because the antibody only targets cancer cells, the ADC does not kill normal cells, making it less likely to cause side effects.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC1+ or 2+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06058988' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab Deruxtecan (T-DXd, Enhertu®)</a> </li></ul>

NEAREST SITE: 2567 miles
Memorial Sloan Kettering Cancer Center
New York,NY

VISITS: At least 6 visits, may require hospitalization

PHASE: I

NCT ID: NCT04150042

Stem Cells with Chemotherapy for Metastatic HER2- Breast Cancer with an Inherited BRCA1/2 or PALB2 Mutation

SHARON: Study of Metastatic Cancers in Patients With an Inherited Defect in a Homologous Recombination Gene Using Autologous Stems Cells and Potentiated Redox Cycling to Overcome Drug Resistance to Nitrogen Mustard Derivatives Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of stem cells with melphalan chemotherapy.

Who is this for?

People with metastatic (stage IV) HER2 negative (HER2-) breast cancer with an inherited (germline) BRCA1, BRCA2, or PALB2 mutation. Full eligibility criteria

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You will receive the following: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Granulocyte colony-stimulating factor</li> </ul> followed by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apheresis procedure to collect stem cells</li> </ul> followed by 2 rounds of: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Melphalan, by IV</li> <li class="seamTextUnorderedListItem">Carmustine (BCNU), by IV</li> <li class="seamTextUnorderedListItem">Vitamin B12b, by IV</li> <li class="seamTextUnorderedListItem">Vitamin C, by IV</li> <li class="seamTextUnorderedListItem">Ethanol, by IV</li> </ul> followed 2 days later by: <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stem cells, by IV</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your stem cells will be collected from your body and modified in a lab so they can identify and attack cancer cells. These modified stem cells will then be infused back into your body.</li> <li class="seamTextUnorderedListItem">Apheresis is a procedure to collect your stem cells. </li> <li class="seamTextUnorderedListItem">Granulocyte colony-stimulating factor is a drug that will help prepare your body and stem cells for apheresis.</li> <li class="seamTextUnorderedListItem">Melphalan is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Carmustine (BCNU), vitamin B12b, vitamin C, and ethanol will be given to improve the effectiveness of the stem cell infusion.</li> <li class="seamTextUnorderedListItem">You will receive two rounds of melphalan (Alkeran®) chemotherapy and stem cell infusion approximately 6 weeks apart.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, PALB2</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04150042' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sharontrial.com/' target='_blank'>General Oncology: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.facingourrisk.org/research-clinical-trials/study/117/a-study-of-melphalan-bcnu-vitamin-b12b-vitamin-c-and-stem-cell-infusion-in-people-with-advanced-pancreatic-cancer-and-brca-mutations' target='_blank'>Facing Our Risk of Cancer Empowered: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/autologous-stem-cell-transplant/pyc-20384859' target='_blank'>Mayo Clinic: Autologous Stem Cell Transplant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/stem-cell-transplant/process.html' target='_blank'>American Cancer Society: Getting a Stem Cell Transplant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/drugs-supplements/melphalan-intravenous-route/side-effects/drg-20071590?p=1#:~:text=Melphalan%20injection%20is%20used%20to,alkylating%20agents%20(cancer%20medicines).' target='_blank'>Mayo Clinic: Melphalan</a> </li></ul>

NEAREST SITE: 2619 miles
Dartmouth Hitchcock Medical Center
Lebanon,NH

VISITS: 1 visit every month

PHASE: II

NCT ID: NCT05933395

Hormone Therapy and Targeted Therapy Based on Biomarker Testing for Advanced ER+, HER2- Breast Cancer

Genetically-informed Therapy for ER+ Breast Cancer in a Post-CDK4/6 Inhibitor Setting: a Phase II Umbrella Study (GERTRUDE) Scientific Title

Purpose

To study the safety, effects (good and bad), and anti-cancer activity of hormone therapy and targeted therapy based on biomarker testing.

Who is this for?

Post-menopausal women with advanced (some stage III) or metastatic (stage IV) estrogen receptor positive (ER+) or ER low, HER2 negative (HER2-) or HER2 low breast cancer. You must have received treatment with palbociclib (Ibrance®), ribociclib (Kisqali®), or abemaciclib (Verzenio®) for advanced disease. Full eligibility criteria

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What's involved?
What's being studied?
How can I learn more?

You will be assigned to 1 of 4 groups based on biomarker testing results: Group 1 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily</li> </ul> Group 2 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®), by mouth, daily</li> </ul> Group 3 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®), by mouth, daily</li> </ul> Group 4 <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection, every 2 weeks for 1 month, then monthly</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®), by mouth, daily</li></ul>
<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">You will receive treatment based on ERBB2, PIK3CA, AKT1, MTOR, PTEN, and RB1 biomarker testing results.</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®) is a type of hormone therapy called a selective estrogen receptor downregulator (SERD). SERDs bind to and break down estrogen receptors.</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is an anti-HER2 targeted therapy that stops cancer cells from growing by targeting and blocking the HER2 proteins that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">Alpelisib (Piqray®) is a type of targeted therapy called a PI3K inhibitor. Blocking the PI3K pathway may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Everolimus (Afinitor®) is a type of targeted therapy called an mTOR inhibitor. It works by interfering with a cancer cell's ability to divide and grow.</li> <li class="seamTextUnorderedListItem">Abemaciclib (Verzenio®) is a type of targeted therapy called a CDK4/6 inhibitor. CDK4/6 inhibitors block two enzymes, CDK4 and CDK6, that help cancer grow.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or 2+/FISH -.</li></ul>
<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05933395' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/faslodex' target='_blank'>Breastcancer.org: Fulvestrant (Faslodex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/nerlynx' target='_blank'>Breastcancer.org: Neratinib (Nerlynx®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/piqray' target='_blank'>Breastcancer.org: Alpelisib (Piqray®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/afinitor' target='_blank'>Breastcancer.org: Everolimus (Afinitor®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/verzenio' target='_blank'>Breastcancer.org: Abemaciclib (Verzenio®)</a> </li></ul>