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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.
Currently viewing trials
(Last updated: May 07, 2026)
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Treatment
Brain Mets
BRCA1/2 (inherited)
Chemotherapy
Hormone Therapy
Leptomeningeal Disease
Radiation Oncology
Surgery
Surgery: Reconstruction
Targeted Therapy: All
Targeted Therapy: ADC
Targeted Therapy: Anti-HER2 Therapy
Targeted Therapy: CDK Inhibitors
Targeted Therapy: PARP Inhibitors
Targeted Therapy: Tumor Mutations
Targeted Therapy: Other Targeted Therapy
Vaccines and Immunotherapy
Other Treatment
Non-Treatment
Activities
Complementary and Integrative Medicine
Decision Support
Diagnosing Breast Cancer
Genetics/Family History
Having Children
Healthy/High Risk
Imaging
Lymphedema
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No Travel Required
Predicting Response to Treatment
Preventing Breast Cancer
Preventing Recurrence
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Surveys/Interviews/Registries
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AKT
ALK
AR
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)
RB
ROS1
TP53
1
NEAREST SITE: 3 miles
California Pacific Medical Center Research Institute
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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<p class="seamTextPara"> You will receive an FDA-approved targeted therapy based on your tumor's genetic profile.</p>
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<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>
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<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>
2
NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA
VISITS: At least 1 visit every week
PHASE: I
NCT ID: NCT06625775
BBO-10203 Targeted Therapy with Trastuzumab for Advanced HER2+ or HR+, HER2- Breast Cancer
A Phase 1a/1b Study of the PI3Kα:RAS Breaker BBO-10203 in Subjects With Advanced Solid Tumors (The BREAKER-101 Study) Scientific Title
Purpose
To study the safety, best dose, and effects (good and bad) of BBO-10203, an experimental targeted therapy, with trastuzumab (Herceptin®) anti-HER2 targeted therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received at least 2 lines of anti-HER2 targeted therapy or hormone receptor positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer who have no standard treatment options available.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BBO-10203, by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, weekly</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BBO-10203 is an experimental targeted therapy called a PI3Kα/AKT inhibitor. Blocking PI3Kα and AKT may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06625775' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://bridgebiooncology.com/platform/' target='_blank'>BridgeBio: BBO-10203 Drug Information Page</a> </li></ul>
3
NEAREST SITE: 3 miles
UCSF at Mission Bay MB
San Francisco,CA
VISITS: Approximately 1 visit every 1-2 weeks
PHASE: III
NCT ID: NCT06435429
Zanidatamab Targeted Therapy with Chemotherapy for Advanced HER2 Positive Breast Cancer
A Phase 3, Randomized, Open-label, Multicenter, Controlled Study to Evaluate the Efficacy and Safety of Zanidatamab in Combination With Physician's Choice Chemotherapy Compared to Trastuzumab in Combination With Physician's Choice Chemotherapy for the Treatment of Participants With Metastatic HER2-positive Breast Cancer Who Have Progressed on, o... Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of zanidatamab, an experimental anti-HER2 targeted therapy, with chemotherapy compared to trastuzumab (Herceptin®) anti-HER2 targeted therapy with chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received trastuzumab deruxtecan (Enhertu®, T-DXd).
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab, by IV</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV, every 1-2 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV, every 1-2 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab is an experimental targeted therapy called a bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to 2 distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">Zanidatamab is a bispecific antibody that binds to 2 targets on HER2.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">In this trial, the chemotherapy drugs are eribulin (Halaven®), gemcitabine (Gemzar®), vinorelbine (Navelbine®), or capecitabine (Xeloda®).</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06435429' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/zanidatamab-combo-appears-exciting-in-her2-hr-metastatic-breast-cancer' target='_blank'>CancerNetwork: Zanidatamab Combo Appears ‘Exciting’ in HER2+/HR+ Metastatic Breast Cancer</a> </li></ul>
4
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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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups and receive the following before surgery: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care therapy</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">4 MRIs</li> <li class="seamTextUnorderedListItem">2 biopsies</li> <li class="seamTextUnorderedListItem">Blood draws</li></ul>
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<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>
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<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>
5
NEAREST SITE: 3 miles
Kaiser Permanente-San Francisco
San Francisco,CA
VISITS: Every 3 weeks for 6 months or 1 year, then every 6 months for 1.5 years
PHASE: III
NCT ID: NCT06876714
Trastuzumab After Surgery for 6 Months or 1 Year for Stage I-III HER2+ Breast Cancer That Responded Completely to Chemotherapy and Trastuzumab Before Surgery
ShortStop-HER2: Shortened Duration of Adjuvant Therapy in Patients With Early-Stage HER2+ Breast Cancer Who Achieve pCR After Neoadjuvant Chemotherapy With HER2 Blockade Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of receiving HER2 targeted therapy for 6 months vs 1 year.
Who is this for?
People with stage I, stage II, or some stage III HER2 positive (HER2+) breast cancer who had a complete response (no cancer is left) after receiving chemotherapy with trastuzumab (Herceptin®) before surgery (neoadjuvant). You must have received surgery and received or plan to receive radiation.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV or injection, every 3 weeks for 1 year</li> <li class="seamTextUnorderedListItem">Heart tests</li> <li class="seamTextUnorderedListItem">Mammogram, ultrasound scan, or MRI scan</li> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Questionnaires, every 6 months for 1.5 years</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV or injection, every 3 weeks for 6 months</li> <li class="seamTextUnorderedListItem">Heart tests</li> <li class="seamTextUnorderedListItem">Mammogram, ultrasound scan, or MRI scan</li> <li class="seamTextUnorderedListItem">Blood tests</li> <li class="seamTextUnorderedListItem">Questionnaires, every 6 months for 1.5 years</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a HER2 targeted therapy commonly used to treat HER2+ breast cancer. </li> <li class="seamTextUnorderedListItem">Receiving HER2-targeted therapy for 6 months may work better than receiving this treatment for 1 year in people whose cancer responded completely to chemotherapy with trastuzumab (Herceptin®) before surgery (neoadjuvant).</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06876714' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.herceptin.com/' target='_blank'>Genentech: Trastuzumab (Herceptin®)</a> </li></ul>
6
NEAREST SITE: 3 miles
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco,CA
VISITS: 1 visit every 3 weeks, for 1 year
PHASE: II
NCT ID: NCT04893109
Trastuzumab by Injection with Chemotherapy or an Antibody-Drug Conjugate for Stage I HER2 Positive Breast Cancer
A Randomized Phase II Trial of Adjuvant Trastuzumab Emtansine (T-DM1) Followed by Subcutaneous Trastuzumab Versus Paclitaxel in Combination With Subcutaneous Trastuzumab for Stage I HER2-positive Breast Cancer (ATEMPT 2.0) Scientific Title
Purpose
To study and compare the safety, side effects, and anti-cancer activity of giving Herceptin Hylecta (trastuzumab by injection) with chemotherapy to giving it with an antibody-drug conjugate.
Who is this for?
People with stage I HER2-positive (HER2+) breast cancer who have already had surgery and completed radiation therapy.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®), by IV, every 3 weeks, for 4.5 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®)/Herceptin Hylecta, by injection, every 3 weeks, for 7.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every week, for 3 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®)/Herceptin Hylecta, by injection, every 3 weeks, for 11.5 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine/T-DM1 (Kadcyla®) is an antibody-drug conjugate (ADC). It uses an antibody -— the HER2-targeted therapy trastuzumab (Herceptin®) -— to deliver the chemotherapy DM1 directly to the cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2 positive breast cancer. </li> <li class="seamTextUnorderedListItem">Herceptin Hylecta is a form of trastuzumab that is given by injection instead of by IV. </li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy routinely used to treat breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04893109' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-new-formulation-herceptin-subcutaneous-use' target='_blank'>FDA Drug Approvals and Database: FDA Approves New Formulation of Herceptin for subcutaneous Use</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/kadcyla' target='_blank'>Breastcancer.org: Trastuzumab Emtansine/T-DM1 (Kadcyla®)</a> </li></ul>
7
NEAREST SITE: 5 miles
University of California, San Francisco
San Francisco,CA
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT05315700
ORIC-114 Targeted Therapy for Advanced HER2+ Breast Cancer
An Open-Label, Phase 1/2 Study of ORIC-114 as a Single Agent or in Combination With Chemotherapy, in Patients With Advanced Solid Tumors Harboring an EGFR or HER2 Alteration Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of ORIC-114, an experimental x, alone or with chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have no standard treatment options available.
Full eligibility criteria
Contact research site
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<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ORIC-114, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ORIC-114, by mouth, daily</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and/or pemetrexed (Alimta®)</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ORIC-114 is an experimental anti-HER2 targeted therapy and blocks EGFR and HER2. Blocking EGFR and HER2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®) and pemetrexed (Alimta®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05315700' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://oricpharma.com/pipeline/#oric114' target='_blank'>ORIC Pharmaceuticals: ORIC-114 Drug Information Page</a> </li></ul>
8
NEAREST SITE: 27 miles
Stanford University Medical Center
Stanford,CA
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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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">XMT-2056, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>
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<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>
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<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>
9
NEAREST SITE: 27 miles
Stanford Health Care, Investigational Drug Service
Stanford,CA
VISITS: Every 2 weeks
PHASE: I-II
NCT ID: NCT06966453
Disitamab Vedotin Antibody-Drug Conjugate for Advanced HER2+, HER2 Low, or HER2 Ultralow Breast Cancer
A Phase 1b/2, Open-Label, Multicohort Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of disitamab vedotin antibody-drug conjugate (ADC).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+), HER2 low, or HER2 ultralow breast cancer. You must have received 1-3 prior lines of therapy for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Disitamab vedotin, by IV, every 2 weeks</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06966453' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizer.com/science/drug-product-pipeline' target='_blank'>Pfizer: Disitamab vedotin</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.pfizerclinicaltrials.com/nct06966453-breast-cancer-trial' target='_blank'>Advanced breast cancer clinical trial NCT06966453 | Pfizer</a> </li></ul>
10
NEAREST SITE: 186 miles
Renown Regional Medical Center
Reno,NV
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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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Chemotherapy</li> </ul> <p class="seamTextPara"> followed by: </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Phesgo, by injection, every 3 weeks</li> <li class="seamTextUnorderedListItem">Chemotherapy</li> </ul> <p class="seamTextPara"> followed by: </p> <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>
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<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>
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<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>
11
NEAREST SITE: 336 miles
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles,CA
VISITS: 1 visit every 3 weeks
PHASE: II
NCT ID: NCT04553770
Trastuzumab Deruxtecan Alone or With Hormone Therapy for Stage II-III HER2 Low, HR Positive Breast Cancer
A Phase II, Multicenter, Open-Label Trial to Evaluate the Safety and Efficacy of Trastuzumab Deruxtecan (DS-8201a) With or Without Anastrozole for HER2 Low Hormone Receptor Positive (HR+) Breast Cancer in the Neoadjuvant Setting Scientific Title
Purpose
To study and compare the anti-cancer acitivity and safety of giving trastuzumab deruxtecan-nxki (Enhertu®) alone or with the anti-estrogen therapy anastrozole (Arimidex®) before surgery (neoadjuvant).
Who is this for?
People with stage II or stage III hormone positive (ER+ and/or PR+), HER2 low expression (defined below) breast cancer whose tumor is 2 cm or larger and who have not yet started treatment.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups and recieve the following before surgery: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan-nxki (Enhertu®), by IV, every 3 weeks, over 4.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan-nxki (Enhertu®), by IV, every 3 weeks, over 4.5 months</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®), by mouth, daily, for 4.5 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">HER2 low expression is defined as IHC 1+ or IHC 2+/ISH-.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is an antibody-drug conjugate (ADC). It uses a HER2 antibody to deliver a chemotherapy directly to cancer cells.</li> <li class="seamTextUnorderedListItem">Anastrozole (Arimidex®) is type of anti-estrogen therapy called an aromatase inhibitor. It is commonly used to treat early stage and metastatic hormone positive (ER+ and/or PR+) breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04553770' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Trastuzumab_deruxtecan' target='_blank'>Wikipedia: Trastuzumab Deruxtecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.enhertuhcp.com/en/?utm_source=google&utm_medium=cpc&utm_campaign=branded+general_2020%3bs%3bph%3bbr%3bonc%3bhcp%3bbr&utm_content=branded+general_2020_exact&utm_term=enhertu&gclid=cj0kcqia48j9brc-arisamqu3wqel0xz_rkoi7g8nk-ckknd1pfqh_i4wknawmwg' target='_blank'>Daiichi-Sankyo Drug Information Page: Enhertu®</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/her2-low-expressing-a-new-subcategory-of-her2-negative-breast-cancer/' target='_blank'>Metastatic Trial Talk: HER2-Low Expressing, A New Subcategory of HER2 Negative Breast Cancer?</a> </li></ul>
12
NEAREST SITE: 336 miles
USC Norris Comprehensive Cancer Center
Los Angeles,CA
VISITS: About 1 visit every 3 weeks
PHASE: I
NCT ID: NCT06253871
IAM1363 Targeted Therapy for Advanced HER2+ or HER2 Mutated Breast Cancer
A Phase 1/1b Study of IAM1363 in Patients with Advanced Cancers Harboring HER2 Alterations Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of IAM1363, an experimental anti-HER2 targeted therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 mutated breast cancer who have received at least 1 line of therapy for advanced disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IAM1363, by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IAM1363 is an experimental anti-HER2 targeted therapy. Blocking HER2 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06253871' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.iambic.ai/pipeline' target='_blank'>Iambic Therapeutics: IAM1363 Drug Information Page</a> </li></ul>
13
NEAREST SITE: 339 miles
UCLA Jonsson Comprehensive Cancer Center
Los Angeles,CA
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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<p class="seamTextPara"> You will be assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: HR positive, HER2 negative</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OKI-219, by mouth, daily</li> <li class="seamTextUnorderedListItem">Fulvestrant (Faslodex®), by injection</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: HER2 positive</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">OKI-219, by mouth, daily</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV</li></ul>
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<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>
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<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>
14
NEAREST SITE: 340 miles
Valkyrie Clinical Trials
Los Angeles,CA
VISITS: Number of visits unavailable
PHASE: I-II
NCT ID: NCT06324357
Zongertinib Targeted Therapy with ADC for Advanced HER2+ Breast Cancer
Beamion BCGC-1: A Phase Ib Dose Escalation and Phase II Dose Optimization, Randomized, Open-label, Multicenter Trial of Oral Zongertinib (BI 1810631) in Combination With Intravenous Trastuzumab Deruxtecan (T-DXd) or in Combination With Intravenous Trastuzumab Emtansine (T-DM1) for Treatment of Patients With Advanced HER2+ Metastatic Breast Cance... Scientific Title
Purpose
To find a dose of zongertinib, an experimental targeted therapy, that people with advanced HER2+ breast cancer can tolerate best when taken with trastuzumab deruxtecan (T-DXd, Enhertu®) or trastuzumab emtansine (T-DM1, Kadcyla®) antibody drug conjugates.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zongertinib (BI 1810631), by mouth</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1, Kadcyla®), by IV</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zongertinib (BI 1810631), by mouth</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®), by IV</li> <li class="seamTextUnorderedListItem">CT scans</li> <li class="seamTextUnorderedListItem">MRI scans</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zongertinib is an experimental anti-HER2 targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®) and trastuzumab emtansine (T-DM1, Kadcyla®) are antibody drug conjugates (ADCs).</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">Trastuzumab deruxtecan (T-DXd, Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1, Kadcyla®)'s antibody targets HER2 and delivers an anti-cancer drug called DM1.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06324357' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/?_gl=1*msj5sm*_ga*NDI3ODYxOTY5LjE2NzE2MzcwODA.*_ga_Y9F235S3X2*MTcxMDc3NDgwNy40MTEuMS4xNzEwNzc2MTM5LjQ2LjAuMA..' target='_blank'>Metastatic Trial Talk: Update On Antibody-Drug Conjugates (ADCs) For MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.boehringer-ingelheim.com/science/human-pharma/clinical-pipeline/oncology/zongertinib-her2-tyrosine-kinase-inhibitor-tki' target='_blank'>Boehringer Ingelheim: Zongertinib (BI 1810631) Drug Information Page</a> </li></ul>
15
NEAREST SITE: 346 miles
Los Angeles Hematology Oncology Medical Group ( Site 0026)
Los Angeles,CA
VISITS: Number of visits unavailable
PHASE: III
NCT ID: NCT07060807
Patritumab Deruxtecan ADC Compared to Chemotherapy or Trastuzumab Deruxtecan for Advanced HR+, HER2- Breast Cancer
An Open-label, Randomized, Phase 3 Study to Evaluate Patritumab Deruxtecan Monotherapy Versus Treatment of Physician's Choice in Hormone Receptor-positive, HER2-negative Unresectable Locally Advanced or Metastatic Breast Cancer (HERTHENA-Breast04) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of patritumab deruxtecan antibody-drug conjugate (ADC) compared to chemotherapy or trastuzumab deruxtecan (T-DXd; Enhertu®) ADC.
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 whose cancer has progressed while receiving a CDK4/6 inhibitor and hormone therapy. You must not have a BRCA mutation and be eligible for treatment with a PARP inhibitor.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Patritumab deruxtecan, by IV, every 3 weeks for 13 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Control</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy or trastuzumab deruxtecan (T-DXd; Enhertu®), for 13 months</li></ul>
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<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. Patritumab deruxtecan is an ADC that binds to HER3, which is found on many breast cancer cells.</li> <li class="seamTextUnorderedListItem">For participants in the control group, the schedule for receiving the drug will vary depending on the drug.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07060807' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.merck.com/research/product-pipeline/' target='_blank'>Merck: Patritumab deruxtecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates</a> </li></ul>
16
NEAREST SITE: 348 miles
University of Southern California
La Jolla,CA
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT07216105
FT836 With or Without Chemotherapy and/or Targeted Therapy for Metastatic Breast Cancer
A Phase 1, Open-Label Study of FT836, an Off-the-Shelf CAR T-Cell Therapy, With or Without Chemotherapy and/or Monoclonal Antibodies, in Participants With Advanced Solid Tumors Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of FT836 cell therapy alone or with chemotherapy or targeted therapy.
Who is this for?
People with stage IV (metastatic) breast cancer who have received at least one line of therapy.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 6 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT836, by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT836, by IV</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 times</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT836, by IV</li> <li class="seamTextUnorderedListItem">Cetuximab (Erbitux®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT836, by IV</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 times</li> <li class="seamTextUnorderedListItem">Cetuximab (Erbitux®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 5</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT836, by IV</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 6</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT836, by IV</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, weekly, 3 times</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">FT836 is a type of cell therapy designed to kill cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07216105' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.fatetherapeutics.com/pipeline/immuno-oncology-candidates/ft836/' target='_blank'>Fate Therapeutics: FT836</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/immunotherapy-mbc-2-2/' target='_blank'>Metastatic Trial Talk: Cell-Based Therapy</a> </li></ul>
17
NEAREST SITE: 353 miles
City of Hope
Duarte,CA
VISITS: 1 visit every 3 weeks
PHASE: II
NCT ID: NCT07007559
Evorpacept Targeted Therapy with Standard of Care Treatment for Advanced HER2+ Breast Cancer
ASPEN-09: A Phase 1b/2, Multicenter, Multi Arm Study of Evorpacept in Combination With Anti-cancer Therapies in Advanced / Metastatic Malignancies Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of evorpacept, an experimental targeted therapy, with standard of care treatment compared to standard of care treatment alone.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received trastuzumab deruxtecan (Enhertu®, T-DXd).
Full eligibility criteria
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<p class="seamTextPara"> You will receive all three of the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evorpacept, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Standard of care chemotherapy</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evorpacept is an experimental targeted therapy called a CD47 inhibitor that allows immune cells to attack and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Your study doctor will choose one of the following chemotherapy options based on your medical history. Standard of care options in this trial are Capecitabine (Xeloda®), Eribulin (Halaven®), Gemcitabine (Gemzar®), Paclitaxel (Taxol®), or Vinorelbine (Navelbine®).</li> <li class="seamTextUnorderedListItem">This study is enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07007559' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://alxoncology.com/our-approach/evorpacept/' target='_blank'>ALX Oncology: Evorpacept Drug Information Page</a> </li></ul>
18
NEAREST SITE: 353 miles
City of Hope Medical Center
Duarte,CA
VISITS: 1 visit every 1-2 months
PHASE: IV
NCT ID: NCT05376878
PET/MRI Scan to Determine Response to Treatment for People with Metastatic HER2+ Breast Cancer with Brain or Leptomeninges Metastasis
Pilot Study to Evaluate 64Cu-DOTA-Trastuzumab Imaging in Patients With HER2+ Breast Cancer With Brain Metastatsis Treated With Fam-Trastuzumab Deruxtecan Scientific Title
Purpose
To find HER2+ breast cancer that has spread to the brain and predict response to treatment with trastuzumab deruxtecan (Enhertu®), an antibody drug conjugate (ADC).
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that has spread to the brain or leptomeninges (brain or leptomeningeal metastasis) who are planning to receive treatment with trastuzumab deruxtecan (Enhertu®).
Full eligibility criteria
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- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">64Cu-DOTA-trastuzumab, by IV, 1 time</li> <li class="seamTextUnorderedListItem">PET/MRI scan, 1 time</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Brain MRI scan, every 1.5 months for 6 months, then every 2 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®), by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">64Cu-DOTA-trastuzumab is an experimental tracer that detects cancer cells during imaging scans.</li> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive tracer to look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy.</li> <li class="seamTextUnorderedListItem">The results of your PET/MRI scan will find the cancer in your brain and may predict your response to treatment.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a type of anti-HER2 targeted therapy used to treat HER2+ breast cancer.</li> <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></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05376878' 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.cedars-sinai.org/programs/imaging-center/exams/nuclear-medicine/pet-mri.html' target='_blank'>Cedars-Sinai: PET/MRI Scan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab deruxtecan (Enhertu®)</a> </li></ul>
19
NEAREST SITE: 353 miles
City of Hope - Duarte Cancer Center
Duarte,CA
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT06760819
BAY2927088 Targeted Therapy for Advanced Breast Cancer with HER2 Mutations
A Phase 2 Open-label Basket Study to Evaluate the Efficacy and Safety of Orally Administered Reversible Tyrosine Kinase Inhibitor BAY 2927088 in Participants With Metastatic or Unresectable Solid Tumors With HER2-activating Mutations (panSOHO) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of BAY2927088, an experimental targeted therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer with a HER2 mutation who have no standard treatment options available.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">BAY2927088, by mouth, daily</li> <li class="seamTextUnorderedListItem">Questionnaires</li> <li class="seamTextUnorderedListItem">Heart tests</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Some breast cancers have changes or mutations to a gene called human epidermal growth receptor 2 (HER2). These mutations can help the cancer grow.</li> <li class="seamTextUnorderedListItem">BAY2927088 is an experimental anti-HER2 targeted therapy called a tyrosine kinase inhibitor. It may block abnormal HER2 which may slow or stop the growth of cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06760819' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/treatments/24984-tyrosine-kinase-inhibitors' target='_blank'>Cleveland Clinic: Tyrosine Kinase Inhibitors</a> </li></ul>
20
NEAREST SITE: 353 miles
City of Hope Comprehensive Cancer Center
Duarte,CA
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT06311214
Biomarker Testing to Select an Antibody-Drug Conjugate for Advanced Breast Cancer
Optimizing Antibody-Drug Conjugate Therapy Through Molecular Analysis for Therapy Choice (ADC MATCH) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of using biomarkers to select an antibody-drug conjugate (ADC).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer who have had a type of blood test called an RNA test.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 3 groups depending on your RNA blood test and biopsy results: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy®), by IV, weekly, 2 weeks on 1 week off</li> <li class="seamTextUnorderedListItem">CT scan</li> <li class="seamTextUnorderedListItem">MRI scan</li> <li class="seamTextUnorderedListItem">Biopsy, two times</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Enfortumab vedotin (Padcev®), by IV, weekly, 3 weeks on 1 week off</li> <li class="seamTextUnorderedListItem">CT scan</li> <li class="seamTextUnorderedListItem">MRI scan</li> <li class="seamTextUnorderedListItem">Biopsy, two times</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">CT scan</li> <li class="seamTextUnorderedListItem">MRI scan</li> <li class="seamTextUnorderedListItem">Echocardiography or multigated acquisition scan (heart scans), 2 times</li> <li class="seamTextUnorderedListItem">Biopsy, two times</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This study is testing the person's blood and tumor for the presence of the biomarkers, TROP-2, nectin 4, or HER2 to match them to one of three ADCs.</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">Sacituzumab govitecan (Trodelvy®) is a TROP-2-targeted ADC approved for triple-negative or HR+, HER2- MBC.</li> <li class="seamTextUnorderedListItem">Enfortumab vedotin (Padcev®) is a nectin4-targeted ADC approved for use in other cancers. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is a HER2-targeted ADC approved for HER2+ or HER2-low MBC.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06311214' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.trodelvy.com/?utm_source=google&utm_medium=cpc&utm_campaign=us_sem_trmd_onc_dtp_ex_mtnbc_go_na_na_b_standard_branded_1432nn&utm_content=17054576844%3B136230621779%3Bkwd-946345024054&utm_term=trodelvy&gclsrc=aw.ds&gad_source=1&gad_campaignid=17' target='_blank'>Gilead: Sacituzumab Govitecan (Trodelvy®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.padcev.com/' target='_blank'>Astellas Pharma: Enfortumab Vedotin (Padcev®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://enhertu.com/en/mbc?utm_source=google&utm_medium=cpc&utm_term=trastuzumab%20deruxtecan&utm_campaign=|CN|DTCB|BR|mBC|ENH|AZ|Core|Alone&utm_source=google&utm_medium=cpc&utm_campaign=%7CCN%7CDTCB%7CBR%7CmBC%7CENH%7CAZ%7CCore%7CAlone&utm_content=Alone%' target='_blank'>Daiichi Sankyo: Trastuzumab Deruxtecan (Enhertu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates (ADCs)</a> </li></ul>
21
NEAREST SITE: 359 miles
Oncology Institute
Long Beach,CA
VISITS: Number of visits unavailable, up to 4 years
PHASE: II
NCT ID: NCT07102381
Zanidatamab Plus Chemotherapy for Stage II-III HER2+ Breast Cancer
A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of zanidatamab (Ziihera®) anti-HER2 bispecific antibody plus chemotherapy.
Who is this for?
People with stage II or stage III HER2 positive (HER2+) breast cancer who are planning to receive therapy before surgery (neoadjuvant) followed by a mastectomy or lumpectomy.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab (Ziihera®), by IV</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV </li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab (Ziihera®), by IV</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV</li> <li class="seamTextUnorderedListItem">Docetaxel (Taxotere®), by IV </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab (Ziihera®) is a bispecific antibody that binds to two places on HER2. It is approved for use in other cancers. Its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Bispecific antibodies bind to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), docetaxel (Taxotere®), and carboplatin (Paraplatin®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are anti-HER2 targeted therapies commonly used to treat HER2+ breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07102381' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ziihera.com/#:~:text=shortness%20of%20breath%20or%20trouble,chest%20discomfort' target='_blank'>Jazz Pharmaceuticals: Zanidatamab (Ziihera®)</a> </li></ul>
22
NEAREST SITE: 381 miles
Hoag Memorial Hospital Presbyterian
Newport Beach,CA
VISITS: Every 3 weeks, up to 4 years
PHASE: I
NCT ID: NCT05872295
IKS014 for Advanced HER2+ or HER2 Low Breast Cancer
A Phase 1 Dose Escalation Trial to Determine the Safety, Tolerance, Maximum Tolerated Dose, and Preliminary Antineoplastic Activity of IKS014, a HER2-Targeting Antibody Drug Conjugate (ADC), in Participants With Advanced HER2+ Solid Tumors Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of IKS014 antibody-drug conjugate (ADC).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low breast cancer. You must have received at least 2 lines of HER2-targeting therapy (if HER2+) or at least 1 line of therapy (if HER2 low). If your cancer is hormone receptor positive (ER+ and/or PR+), you must have received palbociclib (Ibrance®), ribociclib (Kisqali®), or abemaciclib (Verzenio®).
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IKS014, by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IKS014 is a HER2-targeting antibody-drug conjugate (ADC). An ADC is a type of therapy that combines an antibody that targets cancer cells with a therapy that can kill cancer cells.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05872295' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.iksuda.com/adc-programs/iks014/' target='_blank'>Iksuda: IKS014</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/antibody-drug-conjugates/' target='_blank'>Metastatic Trial Talk: Antibody-Drug Conjugates (ADCs)</a> </li></ul>
23
NEAREST SITE: 595 miles
START Mountain Region
West Valley City,UT
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT07361562
CGT4255 for Advanced HER2+ Breast Cancer with or without ERBB2 Mutations
A Study of a Selective ERBB2 Inhibitor, CGT4255, in Patients With Advanced Solid Tumors With ERBB2 Genetic Alterations or HER2 Overexpression Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of CGT4255, an experimental targeted therapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive breast cancer or tests positive for a mutation in HER2 (ERRB2).
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CGT4255, by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">This study is testing a new targeted drug called CGT4255, which is designed to block ERBB2 (HER2) driven cancer growth.</li> <li class="seamTextUnorderedListItem">In HER2 positive breast cancer, the ERBB2 gene is overactive, which causes the cancer cells to produce too much HER2 protein on their surface.</li> <li class="seamTextUnorderedListItem">This study also is enrolling patients with other types of tumors that have these mutations.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07361562' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/about-breast-cancer/her2-positive-breast-cancer-treatment-research/' target='_blank'>Breast Cancer Research Foundation: HER2-Positive Breast Cancer: Testing, Treatment, Research</a> </li></ul>
24
NEAREST SITE: 597 miles
Arizona Oncology Associates, PC - NAHOA
Prescott,AZ
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT06695845
Zanidatamab Targeted Therapy for Advanced HER2 Positive Breast Cancer
A Phase 2, Open-label, Multicenter Study to Evaluate Efficacy and Safety of Zanidatamab for the Treatment of Participants With Previously Treated HER2-expressing Solid Tumors (DiscovHER PAN-206) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of zanidatamab, an experimental targeted therapy.
Who is this for?
People with advanced HER2 positive (HER2+ (IHC3+)) breast cancer who have received trastuzumab deruxtecan (T-DXd, Enhertu®) and have no standard treatment options available.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab, by IV</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab (ZW25) is an experimental anti-HER2 targeted therapy and bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 positive is IHC 3+.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06695845' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zymeworks.com/pipeline#zanidatamab' target='_blank'>Zymeworks Drug Information Page: Zanidatamab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/view/dr-montero-on-zanidatamab-and-evorpacept-in-her2-expressing-metastatic-breast-cancer' target='_blank'>OncLive: Zanidatamab for Metastatic HER2+ Breast Cancer</a> </li></ul>
25
NEAREST SITE: 660 miles
Mayo Clinic in Arizona
Scottsdale,AZ
VISITS: At least 1 visit every 3 weeks
PHASE: I-II
NCT ID: NCT05824975
GI-102 Bispecific Antibody Alone or With Immunotherapy for Advanced Breast Cancer
An Open-label, Multicenter, Dose Escalation and Expansion Phase 1/2 Study to Evaluate the Safety, Tolerability and Pharmacokinetics, and Anti-tumor Activity of GI-102, a CD80-IgG4 Fc-IL-2v Bispecific Fusion Protein, As a Single Agent and in Combination with Conventional Anti-cancer Drugs, Pembrolizumab or Trastuzumab Deruxtecan(T-DXd) in Patient...(KEYNOTE-G08) Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of GI-102, an experimental bispecific antibody, alone or with other anti-cancer drugs.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer.
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 5 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102, by IV or injection, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®, T-DXd), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Chemotherapy, by IV, every 1-3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 5</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®), by IV, every 2 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">GI-102 is an experimental immunotherapy called a bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two different targets and may work better than traditional antibody drugs.</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">Trastuzumab deruxtecan (Enhertu®, T-DXd) is an 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">Trastuzumab deruxtecan (T-DXd, Enhertu®)'s antibody targets HER2 and delivers an anti-cancer drug called deruxtecan.</li> <li class="seamTextUnorderedListItem">The chemotherapies being used in this study are doxorubicin (Doxil®), paclitaxel (Taxol®), and eribulin (Halaven®).</li> <li class="seamTextUnorderedListItem">Bevacizumab (Avastin®) is a targeted therapy called a VEGF inhibitor. Blocking VEGF may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05824975' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/bispecific-antibodies-for-mbc/' target='_blank'>Metastatic Trial Talk: Bispecific Antibodies: An Emerging Class Of MBC Drugs</a> </li></ul>
26
NEAREST SITE: 679 miles
Swedish Cancer Institute
Issaquah,WA
VISITS: 1 visit every 1-2 weeks
PHASE: II
NCT ID: NCT05458674
Targeted Therapy and Chemotherapy for Advanced HER2+ Breast Cancer
A Phase II Study of the Safety, Tolerability and Antitumor Activity of Tucatinib in Combination With Eribulin and Trastuzumab in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of trastuzumab (Herceptin®) anti-HER2 targeted therapy, tucatinib (Tukysa®) tyrosine kinase inhibitor, and eribulin (Halaven®) chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received treatment with trastuzumab (Herceptin®) and chemotherapy for advanced/metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®), by IV, weekly, 2 weeks on, 1 week off</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">Eribulin (Halaven®) is a chemotherapy drug approved to treat metastatic breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05458674' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</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/drugs/halaven' target='_blank'>Breastcancer.org: Eribulin (Halaven®)</a> </li></ul>
27
NEAREST SITE: 682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle,WA
VISITS: 1 or 2 visits a week, for 3 months before surgery
PHASE: II
NCT ID: NCT04329065
WOKVAC Vaccine with Chemotherapy and Two Anti-HER2 Targeted Therapies Before Surgery for Stage I-III, HER2 Positive, HR Negative Breast Cancer
A Phase II Study of Concurrent WOKVAC Vaccination With Neoadjuvant Chemotherapy and HER2-Targeted Monoclonal Antibody Therapy Scientific Title
Purpose
To study the anti-cancer activity, safety and side effects of giving the WOKVAC vaccine in combination with the chemotherapy paclitaxel (Taxol®) and the anti-HER2 targeted therapies trastuzumab (Herceptin®) and pertuzumab (Perjeta®) before surgery.
Who is this for?
People with stage I, stage II or stage III, HER2 positive (HER2+), hormone negative (ER- and PR-) breast cancer who have not yet had surgery. If you have already started chemotherapy before surgery, you will be allowed to enroll but will not receive the vaccine.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following for three months before surgery: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">WOKVAC vaccine, by injection, 3 times</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), by IV, every week (2 weeks on, 1 week off)</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pertuzumab, (Perjeta®), by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">WOKVAC is an experimental vaccine designed to stimulate your immune system to go after and kill cancer cells.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®) is a chemotherapy routinely used to treat breast cancer.</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) and trastuzumab (Herceptin®) are HER2-targeted therapies used to treat HER2 positive (HER2+) breast cancer.</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) is approved to treat early-stage HER2 positive breast cancer with tumors 2 cm or larger or with positive lymph nodes. It's use in this trial may be considered experimental depending upon the size of your tumors and if your lymph nodes are positive for cancer cells.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04329065' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.wingsofkaren.org/dr-king---dr-disis' target='_blank'>Wings of Karen: WOKVAC Vaccine</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/neoadjuvant-therapy/' target='_blank'>Susan G. Komen: Neoadjuvant Therapies for Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/perjeta-plus-herceptin-and-chemo-shows-benefits' target='_blank'>Breastcancer.org: Adding Perjeta to Herceptin and Chemotherapy After Surgery Shows Benefits in Early-Stage HER2-Positive Breast Cancer</a> </li></ul>
28
NEAREST SITE: 1478 miles
Texas Oncology- San Antonio
San Antonio,TX
VISITS: 1 visit every month
PHASE: II
NCT ID: NCT05748834
Tucatinib Targeted Therapy and Doxil Chemotherapy for Advanced HER2+ Breast Cancer
Phase 2 Single Arm Trial With a Safety Lead-in of Tucatinib in Combination With Doxil for the Treatment of HER2+ Metastatic Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of tucatinib (Tukysa®) tyrosine kinase inhibitor with doxorubicin (Doxil®) chemotherapy.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer who have received anti-HER2 targeted therapy.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®), by IV, monthly</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps HER2+ cancer cells grow.</li> <li class="seamTextUnorderedListItem">Doxorubicin (Doxil®) is a chemotherapy drug commonly used to treat breast cancer.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05748834' target='_blank'>ClinicalTrials.gov</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/drugs/doxil' target='_blank'>Breastcancer.org: Doxorubicin (Doxil®)</a> </li></ul>
29
NEAREST SITE: 1482 miles
Baylor University Medical Center, Baylor Charles A Sammons Cancer Center
Dallas,TX
VISITS: Number of visits unavailable
PHASE: I
NCT ID: NCT06008275
Neratinib and Ruxolitinib Targeted Therapy for Women with Advanced TNBC with Chest wall Recurrence
Pilot Clinical Trial Examining the Safety and Efficacy of Neratinib in Combination With Ruxolitinib in Patients With Chemotherapy-pretreated Metastatic Triple Negative Breast Cancer With Chest Wall Recurrence Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of neratinib (Nerlynx®) and ruxolitinib (Jakafi®) targeted therapies.
Who is this for?
Women with advanced (some stage III) triple negative (ER- or ER low, PR-, HER2-) breast cancer with chest wall recurrence. You must have received at least 1 line of chemotherapy for metastatic disease.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Ruxolitinib (Jakafi®), by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is a type of anti-HER2 targeted therapy called an EGFR inhibitor. It blocks EGFR which slows or stops cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Ruxolitinib (Jakafi®) is an experimental targeted therapy called a JAK/STAT3 inhibitor. It may block JAK/STAT3 which may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Ruxolitinib (Jakafi®) is approved for use in other cancers. Its use in this trial is considered experimental.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06008275' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/tnbc-targeted-therapy/' target='_blank'>Metastatic Trial Talk: Triple-Negative Metastatic Breast Cancer: Beyond ER, PR, and HER2</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/tnbc-resistance/' target='_blank'>Metastatic Trial Talk: Discovering New Ways to Overcome Treatment Resistance in Triple-Negative MBC</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/jakafi' target='_blank'>National Cancer Institute: Ruxolitinib (Jakafi®)</a> </li></ul>
30
NEAREST SITE: 1509 miles
University of Texas, Southwestern
Dallas,TX
VISITS: 1 visit every month
PHASE: II
NCT ID: NCT05919108
Neratinib Targeted Therapy with Hormone Therapy Before Surgery for Stage I-III ER+, HER2-, HER2 Mutated Lobular Breast Cancer
Neoadjuvant Neratinib in Stage I-III HER2-Mutated Lobular Breast Cancers Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of neoadjuvant (before surgery) Neratinib (Nerlynx®) anti-HER2 targeted therapy with standard of care hormone therapy.
Who is this for?
People with newly diagnosed stage I, stage II, or stage III estrogen receptor positive (ER+ or ER low), HER2 negative (HER2- or HER2 low), HER2 mutated lobular breast cancer who have not yet received treatment.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care hormone therapy, 1 month</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily, 5 months</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy, 5 months</li> <li class="seamTextUnorderedListItem">Mammogram, ultrasound, or breast MRI</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care hormone therapy, 1 month</li> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily, 1 month</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily, 5 months</li> <li class="seamTextUnorderedListItem">Standard of care hormone therapy, 5 months</li> <li class="seamTextUnorderedListItem">Mammogram, ultrasound, or breast MRI</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) is an anti-HER2 targeted therapy that stops cancer cells. It targets and blocks HER2 proteins that help cancer cells grow.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is IHC 1+ or 2+.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05919108' 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></ul>
31
NEAREST SITE: 1584 miles
University of Minnesota Masonic Cancer Center
Minneapolis,MN
VISITS: 1 visit every 2-3 weeks
PHASE: I
NCT ID: NCT05868226
PRE-I-SPY: Targeted Therapy and Immunotherapy for Advanced HER2+ or HER2 Low Breast Cancer
PRE-Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis: A Phase I/Ib Platform Trial (PRE-I-SPY-PI) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of various combinations of targeted therapy and immunotherapy drugs for people with advanced breast cancer.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) or HER2 low breast cancer who have received no more than 1 line of therapy for advanced disease.
Full eligibility criteria
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- What's involved?
- What's being studied?
- How can I learn more?
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Evorpacept (ALX148) is an experimental immunotherapy called a CD47 inhibitor. Blocking CD47 may help stimulate the immune system to attack and cancer cells.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®) is a type of immunotherapy called an 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">Trastuzumab deruxtecan (Enhertu®) uses the HER2-targeted antibody trastuzumab to deliver the chemotherapy DM1 directly to the cancer cells.</li> <li class="seamTextUnorderedListItem">Zanidatamab is an experimental targeted therapy called a bispecific antibody that binds to 2 targets on HER2.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to 2 distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme, tyrosine kinase, that helps cancer cells grow.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/FISH -.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05868226' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.quantumleaphealth.org/for-patients/i-spy-trials/' target='_blank'>Quantum Leap Healthcare Collaborative: Trial Information Page</a> </li></ul>
32
NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT05673928
Tucatinib and T-DM1 for HER2-Positive Breast Cancer with Brain Metastasis
A Phase II Study of Tucatinib and Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2-positive Metastatic Solid Tumors and Metastases to Brain (TUCATEMEB) Scientific Title
Purpose
To study the anti-cancer activity, safety and side effects of tucatinib and adotrastuzumab emtansine (T-DM1) for controlling brain metastases (breast cancer that has spread to the brain).
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that has spread to the brain.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily for 1 year</li> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (T-DM1; Kadcyla®), by injection, every 3 weeks for 1 year</li></ul>
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<ul class="seamTextUnorderedList"> <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">T-DM1 is an antibody-drug conjugate (ADC). It uses the HER2-targeted therapy trastuzumab to deliver the chemotherapy DM1 directly to cancer cells.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05673928' 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/tukysa' target='_blank'>breastcancer.org: Tucatinib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/kadcyla' target='_blank'>Breastcancer.org: T-DM1</a> </li></ul>
33
NEAREST SITE: 1643 miles
University of Texas MD Anderson Cancer Center
Houston,TX
VISITS: At least 8 visits within 6 months, then 1 visit every 6 months after surgery
PHASE: II
NCT ID: NCT05795101
TRUDI: Trastuzumab Deruxtecan ADC and Durvalumab Immunotherapy for Stage III HER2+ or HER2 Low Inflammatory Breast Cancer
TRUDI: A Phase II Study of Neoadjuvant Trastuzumab Deruxtecan and Durvalumab for Stage III, HER2-expressing Inflammatory Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of neoadjuvant (before surgery) trastuzumab deruxtecan (Enhertu®) antibody drug conjugate (ADC) with durvalumab (Imfinzi®) PD-1 inhibitor.
Who is this for?
People with newly diagnosed stage III HER2 positive (HER2+) or HER2 low inflammatory breast cancer who have not yet received treatment.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®), by IV, every 3 weeks, 8 times</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks, 8 times</li> <li class="seamTextUnorderedListItem">Chest X-rays, every 1.5 months</li></ul>
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<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">Trastuzumab deruxtecan (Enhertru®) has been approved to treat HER2+ and HER2 low breast cancer. Its use in inflammatory breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) 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">Durvalumab (Imfinzi®) has been approved to treat certain types of cancers. Its use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+ and ISH- or ISH untested.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05795101' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab Deruxtecan (Enhertu®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/treatment/drugs/durvalumab' target='_blank'>Cancer Research UK: Durvalumab (Imfinzi®)</a> </li></ul>
34
NEAREST SITE: 1643 miles
M D Anderson Cancer Center
Houston,TX
VISITS: Every 2 weeks for 3 months
PHASE: II
NCT ID: NCT05035836
Neoadjuvant Zanidatamab Targeted Therapy with Hormone Therapy for Stage I-III HER2+ Breast Cancer
A Phase 2 Single-Arm Open-Label Pilot Trial Evaluating Zanidatamab (ZW25) in Patients With Early Stage HER2/Neu Positive (HER2+) Breast Cancer (BC) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of zanidatamab, an experimental anti-HER2 targeted therapy, with letrozole (Femara®) and tamoxifen (Nolvadex®) hormone therapies before surgery (neoadjuvant).
Who is this for?
Women with stage I, stage II, or stage III HER2 positive (HER2+) breast cancer who have not yet received treatment.
Full eligibility criteria
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- What's being studied?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab (ZW25), by IV, every 2 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®), by mouth</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®), by mouth</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Zanidatamab (ZW25) is an experimental anti-HER2 targeted therapy and bispecific antibody.</li> <li class="seamTextUnorderedListItem">A bispecific antibody binds to two distinct targets and may work better than traditional antibody drugs.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) is a type of hormone therapy called an aromatase inhibitor. It is commonly used to treat hormone receptor positive breast cancer.</li> <li class="seamTextUnorderedListItem">Tamoxifen (Nolvadex®) is a type of hormone therapy called a selective estrogen receptor modulator (SERM). SERMs work by blocking the activity of estrogen.</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></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05035836' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.zymeworks.com/pipeline#zanidatamab' target='_blank'>Zymeworks Drug Information Page: Zanidatamab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/femara' target='_blank'>Breastcancer.org: Letrozole (Femara®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/tamoxifen' target='_blank'>Breastcancer.org: Tamoxifen (Nolvadex®)</a> </li></ul>
35
NEAREST SITE: 1761 miles
University of Wisconsin
Madison,WI
VISITS: Every 3 weeks for 6 months
PHASE: II
NCT ID: NCT04886531
Targeted Therapy and Hormone Therapy Before Surgery for Stage I-III Triple Positive Breast Cancer
An Open Label, Phase II Trial of Pre-operative Neratinib and Endocrine Therapy With Trastuzumab in Triple Positive Breast Cancers Hoosier Cancer Research Network BRE17-141 Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of neratinib (Nerlynx®) and trastuzumab (Herceptin®) anti-HER2 targeted therapies with letrozole (Femara®) or anastrozole (Arimidex®) hormone therapies before surgery (neoadjuvant).
Who is this for?
Postmenopausal women and men with stage I, stage II, or some stage III triple positive (ER+, PR+, HER2+) breast cancer who have not yet received surgery.
Full eligibility criteria
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- How can I learn more?
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<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily for 3 weeks</li> </ul> <p class="seamTextPara"> followed 3 weeks later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks for 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily for 3 weeks</li> </ul> <p class="seamTextPara"> followed 3 weeks later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks for 6 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily for 3 weeks</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily for 3 weeks</li> </ul> <p class="seamTextPara"> followed 3 weeks later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) or anastrozole (Arimidex®), by mouth, daily for 6 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks for 6 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®) and trastuzumab (Herceptin®) are anti-HER2 targeted therapies used to treat HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">Letrozole (Femara®) and anastrozole (Arimidex®) are a type of hormone therapy called aromatase inhibitors. They are commonly used to treat hormone receptor positive breast cancer.</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></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04886531' 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.breastcancer.org/treatment/hormonal-therapy/femara' target='_blank'>Breastcancer.org: Letrozole (Femara®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/hormonal-therapy/arimidex' target='_blank'>Breastcancer.org: Anastrozole (Arimidex®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li></ul>
36
NEAREST SITE: 1851 miles
Northwestern University
Evanston,IL
VISITS: Approximately 22 visits over the first 2.5 months; then 1 visit every 2 weeks, ongoing
PHASE: I-II
NCT ID: NCT04588545
Radiation Therapy and HER2-Targeted Therapies Infused Directly into the Brain for HER2+ Breast Cancer with Leptomeningeal Metastases
Phase I/II Study of Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in the Management of HER2+ Breast Leptomeningeal Disease Scientific Title
Purpose
To study the anti-cancer activity and side effects of giving two anti-HER2 targeted therapies directly into the brain after giving radiation therapy to the brain or spine.
Who is this for?
People with metastatic (stage IV) HER2-positive (HER2+) breast cancer with leptomeningeal disease -- breast cancer that has spread to the leptomeninges (see below for the definition).
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy to the brain or spine, 5 to 10 times</li> <li class="seamTextUnorderedListItem">Surgery to place a device (Ommaya reservoir) similar to a chemotherapy port under your scalp</li> <li class="seamTextUnorderedListItem">followed by pertuzumab (Perjeta®) and trastuzumab (Herceptin®), by Ommaya reservoir, twice a week for one month, then once a week for one month, then every two weeks, ongoing</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to kill tumor cells that remain after surgery or other times in the treatment process. </li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®) is a HER2 targeted therapy commonly used to treat HER2-positive breast cancer.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is an anti-HER2 targeted therapy commonly used to treat HER2+ breast cancer. </li> <li class="seamTextUnorderedListItem">Leptomeningeal metastases are when cancer spreads to the membranes surrounding the brain and/or the spinal cord (leptomeninges) or to the cerebrospinal fluid.</li> <li class="seamTextUnorderedListItem">Ommaya reservoirs are very small plastic devices put under the scalp to give access to cerebrospinal fluid (CSF) -- the fluid or liquid surrounding your brain and spinal cord.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of HER2+ cancer that have spread to the leptomeninges.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04588545' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/secondary-cancer/leptomeningeal-metastases/what-are#:~:text=Leptomeningeal%20metastases%20mean%20cancer%20cells,leptomeningeal%20disease' target='_blank'>Cancer Research UK: What are Leptomeningeal Metastases?</a> </li><li class='seamTextUnorderedListItem'><a href='https://moffitt.org/cancers/brain-tumor/leptomeningeal-disease/' target='_blank'>Moffitt Cancer Center: Leptomeningeal Disease</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mskcc.org/cancer-care/patient-education/faq-about-ommaya-reservoirs-and-ommaya-taps' target='_blank'>Memorial Sloan Kettering Cancer Center: Frequently Asked Questions About Ommaya Reservoirs and Ommaya Taps</a> </li></ul>
37
NEAREST SITE: 2223 miles
Prisma Health - Upstate (ITOR)_Edenfield ( Site 0053)
Greenville,SC
VISITS: 1 visit every 3 weeks
PHASE: I-II
NCT ID: NCT06686394
Patritumab Deruxtecan Antibody Drug Conjugate with Anti-HER2 Targeted Therapy for Advanced HER2+ Breast Cancer
HERTHENA-Breast-01: A Phase 1b/2, Multicenter, Open-label, Dose-Finding Study to Evaluate the Safety and Antitumor Activity of Patritumab Deruxtecan in Participants With HER2 Positive Unresectable Locally Advanced Breast Cancer or Metastatic Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of patritumab deruxtecan (MK-1022), an experimental antibody drug conjugate (ADC), with other anti-HER2 targeted therapies.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 positive (HER2+) breast cancer. You must not have received more than 5 previous lines of anti-HER2 targeted therapy. You must not have leptomeningeal metastases (leptomeningeal disease).
Full eligibility criteria
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<p class="seamTextPara"> You will be assigned to 1 of 3 groups based on your treatment history: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Recieved T-DXd and 2-5 Lines of Therapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Patritumab deruxtecan, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Received up to 5 Lines of Therapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Patritumab deruxtecan, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta), by IV, every 3 weeks</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Received T-DXd and up to 3 Lines of Therapy</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Patritumab deruxtecan, by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Patritumab deruxtecan is an experimental HER3-targeted 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">Patritumab deruxtecan's antibody targets HER3 and delivers an anti-cancer drug.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are anti-HER2 targeted therapies commonly used to treat HER2+ breast cancer.</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></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06686394' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.merck.com/research/product-pipeline/' target='_blank'>Merck: Drug Information Page</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>
38
NEAREST SITE: 2352 miles
University of Rochester
Rochester,NY
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT04965064
Neratinib Targeted Therapy with Capecitabine Chemotherapy for Metastatic HER2 Negative Breast Cancer with Abnormally Active HER2 Signaling and Brain Metastases
An Open-Label Phase II Trial of Neratinib Plus Capecitabine in Subjects With HER2-Negative Metastatic Breast Cancer With Brain Metastases and Abnormally Active HER2 Signaling Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of neratinib (Nerlynx®) anti-HER2 targeted therapy with capecitabine (Xeloda®) chemotherapy.
Who is this for?
People with metastatic (stage IV) HER2 negative (HER2-) breast cancer with abnormally active HER2 signaling that has spread to the brain (brain metastasis).
Full eligibility criteria
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- What's being studied?
- How can I learn more?
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Neratinib (Nerlynx®), by mouth, daily</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®), by mouth, daily, 2 weeks on, 1 day off</li></ul>
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<ul class="seamTextUnorderedList"> <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">Neratinib (Nerlynx®) is an oral drug approved by the U.S. Food and Drug Administration (FDA) to treat HER2 positive breast cancer. It is considered investigational in this study because your breast cancer was determined to be HER2 negative by the standard method of testing. However, the CELsignia test showed that your breast cancer cells have HER2 pathway activity that might respond to HER2-targeted treatment.</li> <li class="seamTextUnorderedListItem">Capecitabine (Xeloda®) is a chemotherapy drug that may slow or stop breast cancer cells from growing.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04965064' 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.breastcancer.org/drugs/xeloda' target='_blank'>Breastcancer.org: Capecitabine (Xeloda®)</a> </li></ul>
39
NEAREST SITE: 2352 miles
University of Rochester Medical Center
Rochester,NY
VISITS: 1 visit every 3 weeks
PHASE: II
NCT ID: NCT06750484
Trastuzumab Deruxtecan Antibody Drug Conjugate for Advanced HER2 Negative Breast Cancer
Open-label Single-arm Phase 2 Trial of Trastuzumab Deruxtecan in Previously Treated HER2-Immunohistochemistry (IHC) 0 Advanced Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of trastuzumab deruxtecan (Enhertu®, T-DXd) antibody drug conjugate for people with metastatic HER2 negative breast cancer.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer who have received 1-2 lines of therapy (no anti-HER2 targeted therapies) for advanced disease. Your cancer must have always been considered HER2 negative.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®, T-DXd), by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">About half of breast cancers that are considered HER2 negative actually have low expression of HER2 (HER2 low) and may respond to anti-HER2 targeted therapies.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan is effective and increases survival in people with HER2 low breast cancers.</li> <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></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06750484' target='_blank'>ClinicalTrials.gov</a> </li></ul>
40
NEAREST SITE: 2383 miles
Mayo Clinic in Florida
Jacksonville,FL
VISITS: Number of visits unavailable
PHASE: II
NCT ID: NCT07285044
Receiving Cancer Treatment at Home Instead of in the Clinic for Stage I-IV Breast Cancer
Cancer CARE (Connected Access and Remote Expertise) Beyond Walls - Pilot, Phase 2 Clinical Trial to Evaluate Administration of Cancer-Directed Therapy in the Patient's Homes Versus in Clinic in the Florida Panhandle and Surrounding Areas Scientific Title
Purpose
To study whether providing cancer treatment in the home is preferred over the traditional clinic setting.
Who is this for?
People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer who live in the Florida panhandle area, who are receiving and tolerating standard treatment for their cancer, and who plan to continue to receive these medications for the next 3 months or more. You must not be receiving all your medications by mouth.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">In-home standard of care cancer treatment through CCBW, up to 3 months</li> <li class="seamTextUnorderedListItem">Questionnaires, 3 times within 6 months</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Typically, drug-related cancer treatment is provided at a medical center, which causes patients to have to spend time away from their family and friends. Treatment at a medical center may contribute to the physical, emotional, social, and financial burden of having cancer.</li> <li class="seamTextUnorderedListItem">The Cancer Connected Access and Remote Expertise (CARE) Beyond Walls (CCBW) program uses a specialized care team to provide cancer treatment in the patient's home and may be preferred over the traditional clinic setting.</li> <li class="seamTextUnorderedListItem">At the end of the 3 months of the trial, participants may choose to continue to receive in-home treatment for another 3 months or return to the clinic.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07285044' target='_blank'>ClinicalTrials.gov</a> </li></ul>
41
NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL
VISITS: 1 visit every week
PHASE: II
NCT ID: NCT05325632
Dendritic Cell Vaccine With Neoadjuvant Therapy for HER2 Positive Breast Cancer
A Phase II Study of Human Epidermal Growth Factor Receptor 2 (HER-2) Directed Dendritic Cell (DC1) Vaccine Plus Weekly Paclitaxel, Trastuzumab and Pertuzumab in Patients With HER-2 Positive Breast Cancer Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of a dendritic cell vaccine, an experimental immunotherapy, with targeted therapy and chemotherapy before surgery (neoadjuvant).
Who is this for?
People with stage I, stage II, or some stage III HER2 positive (HER2+) breast cancer who have not received surgery.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apheresis procedure to remove white blood cells</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, weekly for 6 weeks, then 3 times within 6 months</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks for 5 months</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks for 5 months</li> </ul> <p class="seamTextPara"> followed 2 months later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Paclitaxel (Abraxane®), by IV, weekly for 3 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Surgery to remove tumor</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The dendritic cell vaccine is an experimental immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">You will receive a dendritic cell vaccine made from your white blood cells.</li> <li class="seamTextUnorderedListItem">The white blood cells, called dendritic cells, are removed from your body during a procedure called apheresis. These cells are processed in a lab so that they will see and go after HER2+ cancer cells, and then they will be injected as a vaccine.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are types of anti-HER2 targeted therapy used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Abraxane®) is a chemotherapy drug commonly used for breast cancer.</li> <li class="seamTextUnorderedListItem">Neoadjuvant therapy is when you receive treatment, like hormone therapy or targeted therapy, before surgery. Doctors use it to shrink tumors and to see how your cancer responds to the given therapies.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05325632' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/immunotherapy/types/vaccines-to-treat-cancer' target='_blank'>Cancer Research UK: Dendritic Cell Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy#section-cancer-vaccines' target='_blank'>Breastcancerorg: Cancer Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancerorg: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/perjeta' target='_blank'>Breastcancerorg: Pertuzumab (Perjeta®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/drugs/abraxane' target='_blank'>Breastcancerorg: Paclitaxel (Abraxane®)</a> </li></ul>
42
NEAREST SITE: 2395 miles
Moffitt Cancer Center
Tampa,FL
VISITS: May require hospital stay
PHASE: I
NCT ID: NCT05378464
T-Cell Therapy, Dendritic Cell Vaccine & Targeted Therapy for HER2+ Metastatic Breast Cancer
Phase 1 Study of Adoptive T Cell Therapy Following HER2-Pulsed Dendritic Cell Vaccine and Pepinemab / Trastuzumab in Patients With Metastatic HER2-Positive Breast Cancer Scientific Title
Purpose
To study the safety, best dose, effects (good and bad), and anti-cancer activity of T-cell therapy after dendritic cell vaccines with pepinemab, an experimental targeted therapy, and trastuzumab (Herceptin®), a HER2-targeted therapy.
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer that progressed on trastuzumab (Herceptin®). You must not have received more than 3 lines of therapy for metastatic disease.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, weekly for 6 weeks</li> <li class="seamTextUnorderedListItem">Pepinemab, by IV, every 3 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks, ongoing</li> </ul> <p class="seamTextPara"> followed by (2 weeks after last vaccine): </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Cyclophosphamide (Cytoxan®)</li> <li class="seamTextUnorderedListItem">T-cell therapy, by IV, 2 sessions over 2 weeks</li> <li class="seamTextUnorderedListItem">Dendritic cell vaccine, by injection, every 3 weeks for at least 2 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Leukapheresis to collect your T cells</li> <li class="seamTextUnorderedListItem">May require hospital stay</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">T-cell therapy is a type of immunotherapy made from your white blood cells.</li> <li class="seamTextUnorderedListItem">Your T-cells are removed from your body during a process called leukapheresis, modified with CD4+ that allows them to attack HER2 positive cancer cells, and then infused back into your body.</li> <li class="seamTextUnorderedListItem">Before you receive the T-cells, you will be treated with the chemotherapy drug cyclophosphamide (Cytoxan®) to prepare your body to receive the T-cells.</li> <li class="seamTextUnorderedListItem">Dendritic cell vaccines are a type of immunotherapy that boosts the immune system to recognize and destroy cancer cells.</li> <li class="seamTextUnorderedListItem">Pepinemab is an experimental targeted therapy called a SEMA4D inhibitor. Blocking SEMA4D may stop or slow cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) is a HER2-targeted therapy commonly used to treat HER2 positive breast cancer.</li> <li class="seamTextUnorderedListItem">After receiving the modified T-cells, you will continue to receive pepinemab, trastuzumab (Herceptin®), and booster doses of the dendritic cell vaccine every 3 weeks.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05378464' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/adoptive-cell-therapy' target='_blank'>National Cancer Institute: Adoptive T-Cell Therapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/immunotherapy/types/vaccines-to-treat-cancer' target='_blank'>Cancer Research UK: Dendritic Cell Vaccines</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.vaccinex.com/pipeline/pepinemab-immuno-oncology/' target='_blank'>Vaccinex Drug Information Page: Pepinemab</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/herceptin' target='_blank'>Breastcancer.org: Trastuzumab (Herceptin®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/immunotherapy' target='_blank'>Breastcancer.org: Immunotherapy</a> </li></ul>
43
NEAREST SITE: 2539 miles
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ
VISITS: 1 visit every 3 weeks
PHASE: II
NCT ID: NCT07459673
Using ctDNA to Guide Treatment for HER2+ Metastatic Breast Cancer
HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term Remission Scientific Title
Purpose
To study how well circulating tumor DNA (ctDNA) tests work to monitor tumor changes and change treatment in real time.
Who is this for?
People with newly diagnosed metastatic (stage IV) HER2 positive (HER2+) breast cancer.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">2 ctDNA blood tests (Personalis NeXT Personal and Natera Signatera)</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan-nxki (Enhertu®), by IV, once every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Circulating tumor DNA (ctDNA) are small bits of cancer cell DNA that specific tests can find in the bloodstream.</li> <li class="seamTextUnorderedListItem">Studying ctDNA may help your doctor decide to change your treatment earlier (if needed) and may improve your health outcomes.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07459673' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.natera.com/resource-library/signatera/what-is-mrd-testing-and-how-can-it-help-monitor-cancer-recurrence/' target='_blank'>Natera Signatera info page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.personalis.com/next-personal-dx-patients/' target='_blank'>Personalis info page</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/liquid-biopsy/' target='_blank'>Metastatic Trial Talk: Understanding Liquid Biopsies for MBC</a> </li></ul>
44
NEAREST SITE: 2539 miles
Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)
Basking Ridge,NJ
VISITS: Number of visits unavailable, up to 3 years
PHASE: II
NCT ID: NCT07053085
Breast Surgery and Radiation for HER2+ Newly Diagnosed de Novo Oligometastatic Metastatic Breast Cancer
A Randomized Phase II Study of Consolidative Surgery and Radiotherapy With Curative Intent for De Novo Oligometastatic HER2+ Breast Cancer [Ablation and Resection for the Consolidation of Oligometastatic HER2+ Breast Cancer (ARCHER)] Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of the combination of surgery, radiation, and standard of care compared to standard of care only.
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer with 5 or fewer sites of metastasis (oligometastatic), who were diagnosed with breast cancer at stage IV (de novo). All your sites of metastasis must be treatable with surgery or radiation. You must be within the first year of starting first line chemotherapy.
Full eligibility criteria
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<p class="seamTextPara"> You will be randomly assigned to 1 of 2 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Experimental</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast surgery (lumpectomy or mastectomy)</li> <li class="seamTextUnorderedListItem">Radiation to all cancer sites</li> <li class="seamTextUnorderedListItem">Continue standard of care treatment</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Standard of Care</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Continue standard of care treatment</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Standard of care treatment for HER2+ MBC includes trastuzumab (Herceptin®), pertuzumab (Perjeta®), and/or paclitaxel (Taxol®) as determined by your doctor. These drugs are given by your regular doctor and are not given as part of the trial.</li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to damage cancer cell DNA. These x-rays stop cancer cells from dividing and growing, thus slowing or stopping tumor growth.</li> <li class="seamTextUnorderedListItem">Oligometastatic breast cancer is metastatic breast cancer with a small number of metastases.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07053085' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/oligometastatic-breast-cancer/' target='_blank'>Metastatic Trial Talk: Oligometastatic Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/her2-positive-breast-cancer-research-update/' target='_blank'>Metastatic Trial Talk: HER2+ MBC</a> </li></ul>
45
NEAREST SITE: 2549 miles
Overlook Medical Center
Summit,NJ
VISITS: 1 visit every 3 weeks
PHASE: III
NCT ID: NCT05950945
Trastuzumab Deruxtecan ADC for People with Advanced HER2 Negative or HER2 Low Breast Cancer
A Phase 3b, Multicenter, Global, Interventional, Open-label Study of Trastuzumab Deruxtecan (T-DXd), an Anti-HER2-Antibody Drug Conjugate (ADC), in Subjects Who Have Unresectable and/or Metastatic HER2-low or HER2 Immunohistochemistry (IHC) 0 Breast Cancer (DESTINY-Breast15) Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of trastuzumab deruxtecan (T-DXd, Enhertu®) antibody drug conjugate (ADC) for advanced HER2 negative or HER2 low breast cancer.
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer with HER2 negative (IHC 0) or HER2 low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received 1-2 lines of therapy for advanced disease. You must not have received anti-HER2 targeted therapy for advanced disease or any antibody drug conjugate (ADC).
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®), by IV, every 3 weeks</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®) is a type of immunotherapy called an 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">Trastuzumab deruxtecan (Enhertu®) uses the HER2-targeted antibody trastuzumab to deliver the chemotherapy DM1 directly to the 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></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05950945' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.destinyclinicaltrials.com/en#DESTINY-breast' target='_blank'>AstraZeneca: DESTINY Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/enhertu' target='_blank'>Breastcancer.org: Trastuzumab Deruxtecan (Enhertu®)</a> </li></ul>
46
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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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®), by IV</li></ul>
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<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>
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<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>
47
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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<p class="seamTextPara"> You will be assigned to 1 of 4 groups based on biomarker testing results: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <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> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 4</i> </p> <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>
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<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>
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<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>
48
NEAREST SITE: 2693 miles
Dana-Farber Cancer Institute
Boston,MA
VISITS: 1 visit every 1-3 weeks for 1.5 years
PHASE: II
NCT ID: NCT06439693
Multiple Anti-HER2 Targeted Therapies for de Novo Metastatic HER2+ Breast Cancer
A Single-Arm, Phase II Study of Sequential Therapy With Curative Intent in de Novo HER2+ Metastatic Breast Cancer: The SAPPHO Study Scientific Title
Purpose
To study the safety, effects (good and bad), and anti-cancer activity of multiple anti-HER2 targeted therapies in a row instead of changing treatment after cancer progresses.
Who is this for?
People with metastatic (stage IV) HER2 positive (HER2+) breast cancer who were diagnosed with breast cancer at stage IV (de novo). You must not have received treatment except for less than 1.5 months of trastuzumab (Herceptin®), pertuzumab (Perjeta®), and chemotherapy (THP).
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), docetaxel (Taxotere®), or nab-paclitaxel (Abraxane®), by IV, every 1-3 weeks for 3 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®, T-DXd), by IV, every 3 weeks for 4-5 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Trastuzumab emtansine (Kadcyla®, T-DM1), by IV, every 3 weeks for 3 months</li> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by IV, every 3 weeks for 3 months</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Tucatinib (Tukysa®), by mouth, daily for 1 year</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®), by IV, every 3 weeks for 1 year</li> <li class="seamTextUnorderedListItem">Pertuzumab (Perjeta®), by IV, every 3 weeks for 1 year</li></ul>
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<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The U.S. Food and Drug Administration (FDA) has approved all the study drugs as a treatment option for metastatic HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">In standard of care treatment, you typically change treatment after your cancer progresses.</li> <li class="seamTextUnorderedListItem">In this study, you will receive a series of treatments in a row without waiting for disease progression.</li> <li class="seamTextUnorderedListItem">Trastuzumab (Herceptin®) and pertuzumab (Perjeta®) are anti-HER2 targeted therapies used to treat HER2+ breast cancer.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), docetaxel (Taxotere®), or nab-paclitaxel (Abraxane®) are chemotherapy drugs.</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (Enhertu®, T-DXd) and trastuzumab emtansine (Kadcyla®, T-DM1) are antibody drug conjugates (ADCs).</li> <li class="seamTextUnorderedListItem">An 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">Tucatinib (Tukysa®) is a type of targeted therapy called a tyrosine kinase inhibitor. It blocks an enzyme that helps cancer cells grow.</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06439693' target='_blank'>ClinicalTrials.gov</a> </li></ul>
49
NEAREST SITE: 2693 miles
Dana-Farber - Harvard Cancer Center LAO
Boston,MA
VISITS: 2 visits every 3 weeks
PHASE: I
NCT ID: NCT07137416
Pidnarulex and Trastuzumab Deruxtecan for HER2 Positive Advanced Breast Cancer
Phase 1b Study of Pidnarulex and Trastuzumab Deruxtecan in Patients With HER2 Expressing Solid Tumors Scientific Title
Purpose
To study the safety, effects (good and bad), anti-cancer activity, and best dose of pidnarulex combined with trastuzumab deruxtecan (Enhertu®, T-DXd).
Who is this for?
People with advanced (some stage III) or metastatic (stage IV) breast cancer whose tumors express HER2 including HER2 low, or HER2 ultralow, who have received at least 1 prior line of chemotherapy.
Full eligibility criteria
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<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-5461 (Pidnarulex), by IV, every 21 days</li> <li class="seamTextUnorderedListItem">Trastuzumab deruxtecan (T-DXd, Enhertu®), by IV, 1 time</li> <li class="seamTextUnorderedListItem">Follow-up visits, 30 days after treatment ends, and for then for 3 years</li></ul>
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<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT07137416' target='_blank'>ClinicalTrials.gov</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>
