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1

Niraparib Targeted Therapy and Irinotecan Chemotherapy for Advanced Breast Cancer with <span class="highlight">BRCA1,</span> <span class="highlight">BRCA2,</span> ATM, and PALB2 Mutations

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

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

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with a <span class="highlight">BRCA1,</span> <span class="highlight">BRCA2,</span> ATM, and/or PALB2 mutation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, 1 week on, 2 weeks off</li> <li class="seamTextUnorderedListItem">Irinotecan (Camptosar®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®) is a type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA.</li> <li class="seamTextUnorderedListItem">Irinotecan (Camptosar®) is a type of chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Niraparib (Zejula®) and irinotecan (Camptosar®) are approved to treat certain types of cancer. Their use in breast cancer is considered experimental.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: <span class="highlight">BRCA1,</span> <span class="highlight">BRCA2,</span> ATM, PALB2</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05694715' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617007.html' target='_blank'>Medline Plus: Niraparib (Zejula®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a608043.html' target='_blank'>Medline Plus: Irinotecan (Camptosar®)</a> </li></ul>
1

Niraparib Targeted Therapy and Irinotecan Chemotherapy for Advanced Breast Cancer with <span class="highlight">BRCA1,</span> <span class="highlight">BRCA2,</span> ATM, and PALB2 Mutations

Combination Therapy of Niraparib and Irinotecan in Cancers With Mutations in DNA Repair Genes
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Nearest Location:
3 miles
University of California, San Francisco
San Francisco, CA

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Visits:
1 visit every 3 weeks

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ClinicalTrials.gov: NCT05694715

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Phase I

2

Talazoparib in Women With Metastatic Triple Negative or HR+, HER2- Breast Cancer with a Tumor (Not Inherited) <span class="highlight">BRCA1/2</span> Mutation

Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic <span class="highlight">BRCA</span> Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial

Purpose: To study the anti-cancer activity of the PARP inhibitor Talazoparib (Talzenna®) in breast cancer tumors that test positive for a tumor (not inherited) <span class="highlight">BRCA</span> 1 or <span class="highlight">BRCA</span> 2 mutation.

Who is this for?: Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or hormone positive (ER+ and/or PR+), HER2 negative (HER2-) breast cancer. Your tumor must test positive for a <span class="highlight">BRCA</span> 1 or a <span class="highlight">BRCA</span> 2 tumor (not inherited) mutation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a type of targeted therapy called a PARP inhibitor. It prevents the PARP protein from repairing damaged DNA in tumor cells.</li> <li class="seamTextUnorderedListItem">BRCA1/2 mutations are called germline when they are inherited. </li> <li class="seamTextUnorderedListItem">BRCA1/2 mutations are called somatic when they are not inherited.</li> <li class="seamTextUnorderedListItem">Targets or mutations: <span class="highlight">BRCA</span> 1 (tumor), <span class="highlight">BRCA</span> 2 (tumor)</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03990896' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-terms/def/somatic-mutation' target='_blank'>NCI Drug Dictionary: Somatic Mutation</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com/?source=google&HBX_PK=s_talazoparib&skwid=43700039109817433' target='_blank'>Pfizer Oncology: Talzenna®</a> </li><li class='seamTextUnorderedListItem'><a href='https://blog.dana-farber.org/insight/2016/07/how-do-parp-inhibitors-work-in-cancer/' target='_blank'>Dana-Farber Cancer Institue: How Do PARP Inhibitors Work In Cancer? (Video)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/publications/oncology-live/2017/vol-18-no-13/blurring-the-lines-between-germline-and-somatic-mutations-in-cancer' target='_blank'>OncLive: Blurring the Lines Between Germline and Somatic Mutations in Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nature.com/articles/s41416-018-0127-5' target='_blank'>Journal Article: BRCA1/2 Testing: Therapeutic Implications for Breast Cancer Management</a> </li></ul>
2

Talazoparib in Women With Metastatic Triple Negative or HR+, HER2- Breast Cancer with a Tumor (Not Inherited) <span class="highlight">BRCA1/2</span> Mutation

Evaluation of Talazoparib, a PARP Inhibitor, in Patients With Somatic <span class="highlight">BRCA</span> Mutant Metastatic Breast Cancer: Genotyping Based Clinical Trial
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Nearest Location:
3 miles
UCSF Medical Center-Mission Bay/Benioff Children's Hospital
San Francisco, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT03990896

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Phase II

3

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

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. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive an FDA-approved targeted therapy based on your tumor's genetic profile.</p>

What's being studied?

<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, <span class="highlight">BRCA1/2,</span> 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>

How can I learn more?

<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>
3

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
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Nearest Location:
3 miles
Kaiser Permanente - San Francisco Medical Center
San Francisco, CA

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Visits:
Coincides with targeted therapy

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ClinicalTrials.gov: NCT02693535

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Phase II

4

ASTX727 Targeted Therapy with Olaparib for Advanced Breast Cancer with Certain Mutations

A Phase I/Ib Study of Olaparib and ASTX727 in <span class="highlight">BRCA1/2-</span> and HRD-mutated Tumors

Purpose: To study the safety, best dose, effects (good and bad), and anti-cancer activity of ASTX727, an experimental targeted therapy, with olaparib (Lynparza®) PARP inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with <span class="highlight">BRCA1,</span> <span class="highlight">BRCA2,</span> PALB2, ATM, and/or CHEK2 inherited or tumor mutations who have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ASTX727, by mouth</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, every 2 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ASTX727 is an experimental targeted therapy called a DNMT inhibitor. Blocking DNMT may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">ASTX727 is a combination of decitabine with cedazuridine.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">BRCA1, <span class="highlight">BRCA2,</span> PALB2, ATM, and CHEK2 gene mutations are homologous recombination repair (HRR) or homologous recombination deficient (HRD) mutations.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06177171' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://astx.com/research-development/clinical-pipeline/oral-decitabine-and-cedazuridine-astx727-hematological-malignancies/' target='_blank'>Astex Pharmaceuticals: ASTX727 Drug Information Page</a> </li></ul>
4

ASTX727 Targeted Therapy with Olaparib for Advanced Breast Cancer with Certain Mutations

A Phase I/Ib Study of Olaparib and ASTX727 in <span class="highlight">BRCA1/2-</span> and HRD-mutated Tumors
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Nearest Location:
3 miles
University of California, San Francisco
San Francisco, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06177171

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Phase I

5

IMP1734 PARP Inhibitor for Advanced Breast Cancer

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

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

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have received chemotherapy and 0-1 lines of a PARP inhibitor. You must have a <span class="highlight">BRCA1,</span> <span class="highlight">BRCA2,</span> PALB2, ATM, ATR, CHEK2, FANCA, MLH1, MRE11A, NBN, RAD51C, CDK12, or other homologous recombination repair (HRR) mutation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMP1734, by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IMP1734 is an experimental targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06253130' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.eikontx.com/#pipeline' target='_blank'>Eikon Therapeutics: IMP1734/EIK1003 Drug Information Page</a> </li></ul>
5

IMP1734 PARP Inhibitor for Advanced Breast Cancer

A First-in-human, Phase 1/2, Open-label, Multi-center, Dose-escalation, Dose-optimization, and Dose-expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Anti-tumor Activity of PARP1 Selective Inhibitor, IMP1734, as Monotherapy in Patients With Advanced Solid Tumors
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Nearest Location:
3 miles
University of California San Francisco (UCSF)
San Francisco, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06253130

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Phase I-II

6

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

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

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

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer with a tumor or inherited <span class="highlight">BRCA1,</span> <span class="highlight">BRCA2,</span> PALB2, RAD51C, or RAD51D mutation. You must not have received treatment with a PARP inhibitor. You must have at least 1 tumor that has not been treated with radiation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD9574, by mouth</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">AZD9574 is an experimental targeted therapy called a PARP inhibitor. PARP inhibitors stop the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP).</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">The mutations can be inherited (also called germline) or in a tumor (also called somatic).</li> <li class="seamTextUnorderedListItem">Targets or mutations: <span class="highlight">BRCA1,</span> <span class="highlight">BRCA2,</span> PALB2, RAD51C, RAD51D</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05417594' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://aacrjournals.org/cancerres/article/82/12_Supplement/2609/702588' target='_blank'>Abstract: AZD9574</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.komen.org/breast-cancer/treatment/type/parp-inhibitors/' target='_blank'>Susan G. Komen: PARP Inhibitors</a> </li></ul>
6

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

A Modular Phase I/IIa, Open-label, Multi-centre Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of Ascending Doses of AZD9574 as Monotherapy and in Combination With Anti-cancer Agents in Patients With Advanced Solid Malignancies (CERTIS1)
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Nearest Location:
3 miles
Research Site
San Francisco, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05417594

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Phase I-II

7

IDE161 for Advanced Breast Cancer with a <span class="highlight">BRCA</span> Mutation

A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of IDE161, a PARG inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with a <span class="highlight">BRCA1/2</span> mutation whose cancer has progressed on at least one previous therapy. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IDE-161, by mouth</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">IDE161 targets poly(ADP-ribose) glycohydrolase (PARG) and may block cancer cell growth in people with a <span class="highlight">BRCA1</span> mutation.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05787587' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.targetedonc.com/view/phase-1-trial-of-ide161-doses-first-patient-with-advanced-solid-tumors' target='_blank'>Targeted Oncology: Trial for IDE161</a> </li><li class='seamTextUnorderedListItem'><a href='https://filecache.investorroom.com/mr5ir_ideayabio/277/AACR%20Annual%20Meeting%202023%20Poster%206093_PARG_Final.pdf' target='_blank'>Ideayabio Research Poster: IDE161</a> </li></ul>
7

IDE161 for Advanced Breast Cancer with a <span class="highlight">BRCA</span> Mutation

A Study of PARG Inhibitor IDE161 in Participants With Advanced Solid Tumors
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Nearest Location:
3 miles
California Pacific Medical Center
San Francisco, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05787587

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Phase I

8

Talazoparib PARP Inhibitor for Advanced Breast Cancer with a PALB2 Mutation

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

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

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer with a PALB2 mutation who have received 0-3 treatments for advanced/metastatic disease. You must not have a <span class="highlight">BRCA1/2</span> mutation or received treatment with a PARP inhibitor. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04756765' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/talzenna' target='_blank'>Breastcancer.org: Talazoparib (Talzenna®)</a> </li></ul>
8

Talazoparib PARP Inhibitor for Advanced Breast Cancer with a PALB2 Mutation

A Phase 2 Clinical Trial of Talazoparib Monotherapy for PALB2 Mutation Associated Advanced Breast Cancer
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Nearest Location:
27 miles
Stanford University
Stanford, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04756765

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Phase II

9

CX-5461 for Advanced Breast Cancer with a <span class="highlight">BRCA2</span> or PALB2 Mutation

Phase Ib Expansion Study of CX-5461 in Patients With Solid Tumours and <span class="highlight">BRCA2</span> and/or PALB2 Mutation

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

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have a <span class="highlight">BRCA2</span> or PALB2 germline (genetic) mutation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-5461, by IV, 2 times per month</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">CX-5461 is an experimental targeted therapy. </li> <li class="seamTextUnorderedListItem">It targets cells with a Homologous Recombination Deficiency (HRD) mutation. </li> <li class="seamTextUnorderedListItem">It works by slowing down the growth of cancer cells or causing cancer cells to die.</li> <li class="seamTextUnorderedListItem">This trial also is enrolling patients with other types of advanced cancers.</li> <li class="seamTextUnorderedListItem">Targets or mutations: <span class="highlight">BRCA2,</span> PALB2</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04890613' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.prnewswire.com/news-releases/senhwa-biosciences-receives-us-fda-study-may-proceed-letter-to-treat-brca2-or-palb2-solid-tumors-with-cx-5461-301198347.html' target='_blank'>Senhwa Biosciences Press Release: CX-5461</a> </li></ul>
9

CX-5461 for Advanced Breast Cancer with a <span class="highlight">BRCA2</span> or PALB2 Mutation

Phase Ib Expansion Study of CX-5461 in Patients With Solid Tumours and <span class="highlight">BRCA2</span> and/or PALB2 Mutation
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Nearest Location:
339 miles
University of California, Los Angeles
Santa Monica, CA

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Visits:
2 visits per month

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ClinicalTrials.gov: NCT04890613

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Phase I

10

NUV-868 Targeted Therapy for Advanced Triple Negative Breast Cancer

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

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

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have received at least 1 line of chemotherapy for advanced or metastatic disease. If you have a <span class="highlight">BRCA</span> mutation, you must have received treatment with talazoparib (Talzenna®) or olaparib (Lynparza®). View full eligibility criteria

What's involved?

<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">NUV-868, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NUV-868, by mouth, daily</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NUV-868, by mouth, daily</li> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">NUV-868 is an experimental targeted therapy called a BET inhibitor. Blocking BET may help slow or stop the growth of cancer cells.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Enzalutamide (Xtandi®) is a type of targeted therapy called an androgen receptor (AR) inhibitor. It is approved to treat advanced prostate cancer.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: <span class="highlight">BRCA1,</span> <span class="highlight">BRCA2</li></ul></span>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05252390' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nuvationbio.com/pipeline/' target='_blank'>Nuvation Bio: NUV-868 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/lynparza' target='_blank'>Breastcancer.org: Olaparib (Lynparza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a612033.html' target='_blank'>MedlinePlus: Enzalutamide (Xtandi®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org/' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li></ul>
10

NUV-868 Targeted Therapy for Advanced Triple Negative Breast Cancer

Phase 1/2 Safety and Efficacy Study of NUV-868 as Monotherapy and in Combination With Olaparib or Enzalutamide in Adult Patients With Advanced Solid Tumors
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Nearest Location:
341 miles
Ellison Institute of Technology
Los Angeles, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05252390

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Phase I-II

11

Ceralasertib Alone or With Chemotherapy or With Olaparib in Advanced Breast Cancer

A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD6738 in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies.

Purpose: To study the safety, effects, and best dose of Ceralasertib when it is used alone or with the chemotherapy carboplatin or the PARP inhibitor olaparib (Lynparza®).

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will be assigned to 1 of 3 groups: </p> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 1: Open to all MBC patients</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ceralasertib, by mouth </li> <li class="seamTextUnorderedListItem">Carboplatin (Paraplatin®), by IV, every 3 weeks for up to 4.5 months</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2: Open to all MBC patients </i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ceralasertib, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 3: Open to Triple Negative Breast Cancer MBC patients with or without a <span class="highlight">BRCA</span> mutation</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ceralasertib, by mouth</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Additional Procedures</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">3 biopsies</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Ceralasertib is a new type of targeted therapy called an ATR inhibitor. </li> <li class="seamTextUnorderedListItem">It disrupts a cancer cell's ability to repair its own DNA, which can cause the cancer cells to die. </li> <li class="seamTextUnorderedListItem">Carboplatin is a chemotherapy used to treat breast cancer. </li> <li class="seamTextUnorderedListItem">Lynparza is a PARP inhibitor approved to treat <span class="highlight">BRCA</span> 1 or <span class="highlight">BRCA</span> 2 positive metastatic breast cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02264678' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/atr-kinase-inhibitor-azd6738' target='_blank'>NCI Drug Dictionary: Ceralasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/olaparib' target='_blank'>NCI Drug Dictionary: Olaparib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.onclive.com/publications/oncology-live/2018/vol-19-no-24/targeting-cancers-achilles-heel-dna-damage-response-networks-beyond-parp' target='_blank'>OncLive: DNA Damage Response Networks Beyond PARP</a> </li></ul>
11

Ceralasertib Alone or With Chemotherapy or With Olaparib in Advanced Breast Cancer

A Modular Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of AZD6738 in Combination With Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anti-cancer Agents in Patients With Advanced Solid Malignancies.
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Nearest Location:
353 miles
Research Site
Duarte, CA

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT02264678

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Phase I-II

12

Niraparib and Dostarlimab for <span class="highlight">BRCA+</span> Advanced Breast Cancer

Phase IB Trial of Niraparib and TSR-042 in Patients With <span class="highlight">BRCA-Mutated</span> Breast, Pancreas or Ovary Cancer

Purpose: To study the anti-cancer activity of giving niraparib, a PARP inhibitor, and dostarlimab (TSR-042), an immunotherapy, together.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with a <span class="highlight">BRCA1</span> or <span class="highlight">BRCA2</span> mutation. The <span class="highlight">BRCA1</span> or <span class="highlight">BRCA2</span> mutation can be hereditary (genetic) or tumor-based (genomic). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, twice a day, ongoing</li> <li class="seamTextUnorderedListItem">Dostarlimab (TSR-042, Jemperli®), by IV, every 3 weeks (4 times), then every 6 weeks, ongoing</li> <li class="seamTextUnorderedListItem">2 biopsies</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®) is a type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA. </li> <li class="seamTextUnorderedListItem">Dostarlimab (TSR-042, Jemperli®) is a type of immunotherapy called a PD-1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: <span class="highlight">BRCA1</span> or <span class="highlight">BRCA2</span> hereditary (genetic) or tumor-based (genomic)</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04673448' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/from-the-experts/genetic-vs-genomic-testing/' target='_blank'>Metastatic Trial Talk: Genetic vs. Genomic Testing</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancernetwork.com/view/dostarlimab-gains-new-fda-approved-indication-mismatch-repair-deficient-tumors' target='_blank'>CancerNetwork: Dostarlimab Gains New FDA-Approved Indication for Treatment of Mismatch Repair–Deficient Tumors</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a621030.html' target='_blank'>MedLinePlus: Dostarlimab</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/parp-inhibitors-cancer/' target='_blank'>Metastatic Trial Talk: PARP Inhibitors</a> </li></ul>
12

Niraparib and Dostarlimab for <span class="highlight">BRCA+</span> Advanced Breast Cancer

Phase IB Trial of Niraparib and TSR-042 in Patients With <span class="highlight">BRCA-Mutated</span> Breast, Pancreas or Ovary Cancer
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Nearest Location:
682 miles
Fred Hutch/University of Washington Cancer Consortium
Seattle, WA

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Visits:
1 visit every 3 weeks for 3 months, then every 6 weeks, ongoing

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ClinicalTrials.gov: NCT04673448

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Phase I

13

A Registry for People with Triple Negative or ER Low, HER2- Breast Cancer or an Inherited <span class="highlight">BRCA1/2</span> or Certain Other Mutations

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

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

Who is this for?: People with inherited <span class="highlight">BRCA1/2</span> mutations or certain other genetic mutations (see list below) and people with stage I, stage II, stage III, or stage IV triple negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> This is a data collection (registry) study. You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">1 blood test</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low.</li> <li class="seamTextUnorderedListItem">This trial is enrolling people with triple negative as well as ER Low breast cancer.</li> <li class="seamTextUnorderedListItem">Studies have found a relationship between triple negative breast cancer and inherited <span class="highlight">BRCA1</span> and <span class="highlight">BRCA2</span> mutations. </li> <li class="seamTextUnorderedListItem">Targets or mutations: <span class="highlight">BRCA1,</span> <span class="highlight">BRCA2,</span> PTEN, P53, and PALB2</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT02302742' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='http://www.cancer.net/cancer-types/hereditary-breast-and-ovarian-cancer' target='_blank'>ASCO: Hereditary Breast and Ovarian Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='http://ww5.komen.org/BreastCancer/InheritedGeneticMutations.html' target='_blank'>Susan G. Komen: Inherited Gene Expressions</a> </li><li class='seamTextUnorderedListItem'><a href='https://tnbcfoundation.org' target='_blank'>Triple Negative Breast Cancer Foundation</a> </li><li class='seamTextUnorderedListItem'><a href='https://ghr.nlm.nih.gov/condition/breast-cancer' target='_blank'>NIH Genetics Home Reference: Breast Cancer</a> </li></ul>
13

A Registry for People with Triple Negative or ER Low, HER2- Breast Cancer or an Inherited <span class="highlight">BRCA1/2</span> or Certain Other Mutations

PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations (PROGECT)
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Nearest Location:
1251 miles
Hays Medical Center Dreiling-Schmidt Cancer Institute
Hays, KS

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Visits:
1 visit

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ClinicalTrials.gov: NCT02302742

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Phase NA

14

ART6043 Targeted Therapy for Advanced HER2- Breast Cancer with a <span class="highlight">BRCA</span> Mutation

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

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

Who is this for?: People with advanced (stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer with a <span class="highlight">BRCA1/2</span> mutation who have received treatment with paclitaxel (Taxol®), docetaxel (Taxotere®), or cabazitaxel (Jevtana®) chemotherapy. You must not have received more than 3 lines of chemotherapy including antibody drug conjugates (ADC) for advanced disease. View full eligibility criteria

What's involved?

<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">ART6043, by mouth</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) or talazoparib (Talzenna®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) or talazoparib (Talzenna®)</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Please contact research site for treatment schedule</i></p>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ART6043 is an experimental targeted therapy called a DNA polymerase theta inhibitor. DNA polymerase theta inhibitors work by blocking the action of DNA polymerase theta, an enzyme that helps cancer cells repair DNA.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynpara®) and talazoparib (Talzenna®) are types of targeted therapy called PARP inhibitors. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps cancer cells repair DNA.</li> <li class="seamTextUnorderedListItem">Targets or mutations: <span class="highlight">BRCA1,</span> <span class="highlight">BRCA2</li></ul></span>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05898399' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.artios.com/pipeline/' target='_blank'>Artios Pharma: ART6043 Drug Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/lynparza' target='_blank'>Breastcancer.org: Olaparib (Lynparza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/talzenna' target='_blank'>Breastcancer.org: Talazoparib (Talzenna®)</a> </li></ul>
14

ART6043 Targeted Therapy for Advanced HER2- Breast Cancer with a <span class="highlight">BRCA</span> Mutation

A Phase I/IIa, Open-label, Multi-center Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of the DNA Polymerase Theta Inhibitor ART6043 Administered Orally as Monotherapy and in Combination to Patients With Advanced or Metastatic Solid Tumors
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Nearest Location:
1387 miles
Stephenson Cancer Center - Oncology
Oklahoma City, OK

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05898399

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Phase I-II

15

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

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

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

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

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®) is a PARP inhibitor that is approved to treat people with advanced or metastatic HER2 negative (HER2-) breast cancer and an inherited <span class="highlight">BRCA1</span> or <span class="highlight">BRCA2</span> mutation, but its use in this trial is considered experimental. </li> <li class="seamTextUnorderedListItem">PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of advanced cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: ATM, BACH1 (BRIP1), BARD1, <span class="highlight">BRCA1/2</span> (tumor or inherited), CDK12, CHK1, CHK2, IDH1, IDH2, MRE11A, NBN, PALB2, RAD50, RAD51, RAD51B, RAD51C, RAD51D, RAD54L, FANCA, FANCB, FANCC, FANCD2, FANCE, FANCF, FANCG, FANCI, FANCJ, FANCL, FANCM and FANCN</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04550494' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/targeted-cancer-drugs/types/PARP-inhibitors' target='_blank'>Cancer Research UK: PARP Inhibitors</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com/?source=google&HBX_PK=s_talazoparib&skwid=43700051780449266' target='_blank'>Pfizer Oncology Drug Information Page: Talzenna® (Talazoparib)</a> </li></ul>
15

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

A Pharmacodynamics-Driven Trial of Talazoparib, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Aberrations in Genes Involved in DNA Damage Response
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Nearest Location:
1387 miles
University of Oklahoma Health Sciences Center
Oklahoma City, OK

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04550494

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Phase II

16

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

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

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

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer who have received 0-1 lines of therapy for advanced disease. You must have a <span class="highlight">BRCA1,</span> <span class="highlight">BRCA2,</span> PALB2, ATM, ATR, CHEK2, FANCA, MLH1, MRE11A, NBN, RAD51C, CDK12, or other homologous recombination repair (HRR) or homologous recombination deficiency (HRD) mutation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VIO-01, by IV, weekly</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">VIO-01 is an experimental targeted therapy called a DNA decoy drug. VIO-01 may prevent tumor cells from repairing tumor DNA which helps cancer grow.</li> <li class="seamTextUnorderedListItem">BRCA1, <span class="highlight">BRCA2,</span> PALB2, ATM, ATR, CHEK2, FANCA, MLH1, MRE11A, NBN, RAD51C, CDK12, are types of homologous recombination repair (HRR) or homologous recombination deficiency (HRD) mutations.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06257758' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://valeriotx.com/our-science/#pipeline' target='_blank'>Valerio Therapeutics: VIO-01 Drug Information Page</a> </li></ul>
16

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

A Phase 1/2 Study of VIO-01 in Participants With Recurrent Solid Tumors
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Nearest Location:
1481 miles
Next Oncology
San Antonio, TX

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Visits:
1 visit every week

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ClinicalTrials.gov: NCT06257758

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Phase I-II

17

ATX-559 Targeted Therapy for Advanced HER2-/BRCA+ or dMMR/MSI-H Breast Cancer

A Phase 1/2, Open-Label, Dose-Escalation and Expansion First-In-Human Study of ATX-559, an Oral Inhibitor of the Helicase DHX9, in Patients with Locally Advanced or Metastatic Solid Tumors and Molecularly Defined Cancers

Purpose: To study the safety, best dose, and effects (good and bad) of ATX-559, an experimental DHX9 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer with a <span class="highlight">BRCA1/2</span> mutation, or breast cancer with a dMMR or MSI-H mutation. You must have no standard treatment options available. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ATX-559, by mouth</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">ATX-559 is an experimental targeted therapy called a DHX9 inhibitor. Blocking DHX9 may slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Microsatellite instability high (MSI-H) and deficient mismatch repair (dMMR) mutations include MLH1, MSH2, MSH6, and PMS.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06625515' target='_blank'>ClinicalTrials.gov</a> </li></ul>
17

ATX-559 Targeted Therapy for Advanced HER2-/BRCA+ or dMMR/MSI-H Breast Cancer

A Phase 1/2, Open-Label, Dose-Escalation and Expansion First-In-Human Study of ATX-559, an Oral Inhibitor of the Helicase DHX9, in Patients with Locally Advanced or Metastatic Solid Tumors and Molecularly Defined Cancers
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Nearest Location:
1481 miles
NEXT Oncology
San Antonio, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06625515

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Phase I

18

MOMA-313 Targeted Therapy Alone or with PARP Inhibitor for Advanced Breast Cancer with HRD Mutations

A Phase 1 Study of MOMA-313 Given as Monotherapy or in Combination With a PARP Inhibitor in Participants With Advanced or Metastatic Solid Tumors

Purpose: To study the safety, best dose, and effects (good and bad) of MOMA-313, an experimental DNA polymerase theta inhibitor, alone or with olaparib (Lynparza®) PARP inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with a <span class="highlight">BRCA1,</span> <span class="highlight">BRCA2,</span> PALB2, ATM, or CHEK2 mutation. View full eligibility criteria

What's involved?

<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">MOMA-313, by mouth</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MOMA-313, by mouth</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">MOMA-313 is an experimental targeted therapy called a DNA polymerase theta inhibitor.</li> <li class="seamTextUnorderedListItem">MOMA-313 was designed to target homologous recombination (HR)-deficient cancers by inhibiting DNA polymerase theta.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">BRCA1, <span class="highlight">BRCA2,</span> PALB2, ATM, and CHEK2 gene mutations are homologous recombination repair (HRR) or homologous recombination deficient (HRD) mutations.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06545942' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.urologytimes.com/view/study-launches-of-moma-313-in-solid-tumors-including-prostate-cancer' target='_blank'>Urology Times: Study of MOMA-313 in Solid Tumors</a> </li></ul>
18

MOMA-313 Targeted Therapy Alone or with PARP Inhibitor for Advanced Breast Cancer with HRD Mutations

A Phase 1 Study of MOMA-313 Given as Monotherapy or in Combination With a PARP Inhibitor in Participants With Advanced or Metastatic Solid Tumors
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Nearest Location:
1481 miles
Investigative Site #105
San Antonio, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06545942

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Phase I

19

PARP Inhibitor Olaparib with Cediranib or Ceralasertib for Women with Advanced, HER2-, Inherited <span class="highlight">BRCA+</span> Breast Cancer

Overcoming PARP Inhibitor Resistance in <span class="highlight">BRCA</span> Germline Mutation Positive Advanced Breast Cancer

Purpose: To study the anti-cancer activity and safety of combining the PARP inhibitor olaparib (Lynparza®) with an experimental targeted therapy--either cediranib or ceralasertib.

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV), HER2 negative (HER2-), inherited <span class="highlight">BRCA</span> positive <span class="highlight">(BRCA1/2+)</span> breast cancer. View full eligibility criteria

What's involved?

<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">Olaparib (Lynparza®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Cediranib, by mouth, daily</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice daily</li> <li class="seamTextUnorderedListItem">Ceralasertib, by mouth, daily (one week on, three weeks off)</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. It stops the growth of cancer cells by blocking enzymes called poly ADP ribose polymerase (PARP) and is already approved for use in women with metastatic, HER2-negative, inherited <span class="highlight">BRCA1/2</span> positive breast cancer. </li> <li class="seamTextUnorderedListItem">Cediranib is a tyrosine kinase inhibitor, a type of targeted therapy, that is designed to block the VEGF (vascular endothelial growth factor receptor) protein. </li> <li class="seamTextUnorderedListItem">Tumors use VEGF to grow new blood vessels. </li> <li class="seamTextUnorderedListItem">Research suggests VEGF inhibitors may slow or stop cancer cell growth. Giving cediranib with olaparib may also make the olaparib more effective. </li> <li class="seamTextUnorderedListItem">Ceralasertib is a new type of targeted therapy called an ATR inhibitor. It disrupts a cancer cell's ability to repair its own DNA, which can cause the cancer cells to die.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04090567' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/lynparza' target='_blank'>Breastcancer.org: Lynparza</a> </li><li class='seamTextUnorderedListItem'><a href='https://en.wikipedia.org/wiki/Cediranib' target='_blank'>Wikipedia: Cediranib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/atr-kinase-inhibitor-azd6738' target='_blank'>NCI Drug Dictionary: Ceralasertib</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.nejm.org/doi/full/10.1056/nejmoa1706450' target='_blank'>Journal Article: Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/lynparza-brca-treatment/' target='_blank'>Metastatic Trial Talk: Treating BRCA1/2 Metastatic Breast Cancer</a> </li></ul>
19

PARP Inhibitor Olaparib with Cediranib or Ceralasertib for Women with Advanced, HER2-, Inherited <span class="highlight">BRCA+</span> Breast Cancer

Overcoming PARP Inhibitor Resistance in <span class="highlight">BRCA</span> Germline Mutation Positive Advanced Breast Cancer
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Nearest Location:
1643 miles
M D Anderson Cancer Center
Houston, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04090567

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Phase II

20

Niraparib and Dostarlimab for Metastatic Triple-Negative or <span class="highlight">BRCA1/2</span> Mutant Breast Cancer that has Spread to the Brain

Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)

Purpose: To study the safety, effects (good and bad), and anti-cancer activity of the combination of niraparib (Zejula®), a PARP inhibitor, and dostarlimab (Jemperli®), an immunotherapy, to control breast cancer that has spread to the brain.

Who is this for?: People with metastatic (stage IV) triple negative (ER-, PR-, HER2-) or <span class="highlight">BRCA1/2</span> mutated breast cancer that has spread to the brain (brain metastasis). You must have received at least one standard treatment. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®), by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®) is a type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA.</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®) 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">Cerebrospinal fluid (CSF) is the fluid that surrounds your brain and spinal cord. CSF is typically collected during a procedure called a lumbar puncture, also known as a spinal tap.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT05700721' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li></ul>
20

Niraparib and Dostarlimab for Metastatic Triple-Negative or <span class="highlight">BRCA1/2</span> Mutant Breast Cancer that has Spread to the Brain

Phase II Trial of the PARP Inhibitor Niraparib and PD-1 Inhibitor Dostarlimab in Patients With Advanced Cancers With Active Progressing Brain Metastases (STARLET)
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Nearest Location:
1643 miles
M D Anderson Cancer Center
Houston, TX

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT05700721

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Phase II

21

PARP Inhibitor Olaparib and the Chemotherapy Vorinostat for Advanced HER2 Negative Breast Cancer

Multicenter Phase I/Ib Trial of Olaparib in Combination With Vorinostat in Patients With Relapsed/Refractory and/or Metastatic Breast Cancer

Purpose: To study the safety, dose, and anti-cancer activity of giving a PARP inhibitor in combination with chemotherapy.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Vorinostat (Zolinza®), by mouth, daily, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Olaparib is approved to treat metastatic HER2 negative breast cancer in people with a <span class="highlight">BRCA</span> 1/2 genetic (inherited) mutation. However, the use of olaparib in this trial is considered investigational. </li> <li class="seamTextUnorderedListItem">Vorinostat (Zolinza®) is chemotherapy approved to treat a type of cancer called T-cell lymphoma. Its use in this trial is considered investigational.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03742245' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted_therapies/lynparza' target='_blank'>Breastcancer.org: Olaparib</a> </li><li class='seamTextUnorderedListItem'><a href='http://chemocare.com/chemotherapy/drug-info/Vorinostat.aspx' target='_blank'>Chemocare: Vorinostat</a> </li></ul>
21

PARP Inhibitor Olaparib and the Chemotherapy Vorinostat for Advanced HER2 Negative Breast Cancer

Multicenter Phase I/Ib Trial of Olaparib in Combination With Vorinostat in Patients With Relapsed/Refractory and/or Metastatic Breast Cancer
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Nearest Location:
1643 miles
Houston Methodist Cancer Center
Houston, TX

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Visits:
Please contact research site

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ClinicalTrials.gov: NCT03742245

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Phase I

22

An Experimental PET/CT Scan to Find PARP-Expressing Tumor Cells

Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CT

Purpose: To study the safety and effectiveness of using a PET/CT scan with the experimental tracer F-18.

Who is this for?: People with stage I, stage II, stage III, or stage IV (metastatic) breast cancer or DCIS. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">F-18 tracer, by IV, then a PET/CT scan</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">A positron emission tomography (PET) scan is an imaging test that uses a radioactive substance called a tracer that can look for and attach to cancer cells.</li> <li class="seamTextUnorderedListItem">The tracer used in this imaging trial is called fluorine F 18 fluorthanatrace (F-18)--it binds to PARP expressing tumor cells (PARP is a protein over expressed in certain cancers). </li> <li class="seamTextUnorderedListItem">You do not need to have an inherited <span class="highlight">BRCA1/2</span> mutation to enroll in this trial but researchers are studying whether F-18 works better in inherited <span class="highlight">BRCA1/2+</span> cancers. </li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of solid tumors.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT03604315' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://my.clevelandclinic.org/health/diagnostics/10123-pet-scan' target='_blank'>Cleveland Clinic: PET Scan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/fluorine-f-18-fluorthanatrace' target='_blank'>NCI Drug Dictionary: Fluorine F 18 Fluorthanatrace</a> </li></ul>
22

An Experimental PET/CT Scan to Find PARP-Expressing Tumor Cells

Serial Imaging of the Novel Radiotracer [^18F] FLuorthanatrace ([^18F] FTT) by PET/CT
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Nearest Location:
1643 miles
M D Anderson Cancer Center
Houston, TX

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Visits:
1 to 2 visits

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ClinicalTrials.gov: NCT03604315

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Phase I

23

Targeted Therapy, Radiation, Chemotherapy, and Immunotherapy for Metastatic Triple Negative or HER2-, <span class="highlight">BRCA</span> Mutated Breast Cancer with Brain Metastases

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

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

Who is this for?: Postmenopausal women or men with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer or HER2 negative (HER2-) breast cancer that has spread to the brain (brain metastasis). If you have HER2- breast cancer, you must also have a germline (inherited) or somatic (tumor) <span class="highlight">BRCA</span> mutation. You must have at least 1 brain tumor that has not been treated with radiation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily for 1 month</li> <li class="seamTextUnorderedListItem">Stereotactic radiosurgery (SRS), 1-5 times</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Physician's choice of chemotherapy: Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), eribulin (Halaven®), carboplatin (Paraplatin®), cisplatin (Platinol®), capecitabine (Xeloda®), or gemcitabine (Gemzar®)</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®), by IV, every 3 weeks</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Stereotactic radiation (stereotactic radiosurgery) delivers high-dose, precisely-targeted radiation in fewer doses than traditional radiation therapy.</li> <li class="seamTextUnorderedListItem">Paclitaxel (Taxol®), nab-paclitaxel (Abraxane®), eribulin (Halaven®), carboplatin (Paraplatin®), cisplatin (Platinol®), capecitabine (Xeloda®), or gemcitabine (Gemzar®) are chemotherapy drugs that slow or stop cancer cells from growing.</li> <li class="seamTextUnorderedListItem">Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 inhibitor, which is a type of immune checkpoint inhibitor. Blocking PD-L1 may allow the body's immune system to detect and fight cancer cells.</li> <li class="seamTextUnorderedListItem">Targets or mutations: <span class="highlight">BRCA</li></ul></span>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04711824' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://mbcbrainmets.org/' target='_blank'>MBCBrainMets.org</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/targeted-therapy/lynparza' target='_blank'>Breastcancer.org: Olaparib (Lynparza®)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/stereotactic-radiosurgery/about/pac-20384526' target='_blank'>Mayo Clinic: Stereotactic Radiosurgery</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/treatment/chemotherapy' target='_blank'>Breastcancer.org: Chemotherapy</a> </li><li class='seamTextUnorderedListItem'><a href='https://medlineplus.gov/druginfo/meds/a617030.html' target='_blank'>MedlinePlus: Durvalumab (Imfinzi®)</a> </li></ul>
23

Targeted Therapy, Radiation, Chemotherapy, and Immunotherapy for Metastatic Triple Negative or HER2-, <span class="highlight">BRCA</span> Mutated Breast Cancer with Brain Metastases

Phase I/II Study of Stereotactic Radiosurgery With Concurrent Administration of DNA Damage Response (DDR) Inhibitor (Olaparib) Followed by Adjuvant Combination of Durvalumab (MEDI4736) and Physician's Choice Systemic Therapy in Subjects With Breast Cancer Brain Metastases
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Nearest Location:
1946 miles
Indiana University Melvin and Bren Simon Comprehensive Cancer Center
Indianapolis, IN

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT04711824

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Phase I-II

24

Radiation, Immunotherapy and a PARP Inhibitor for Advanced Triple-Negative or ER Low Breast Cancer

A Phase II Study of NirAparib, Dostarlimab and Radiotherapy in Metastatic, PD-L1 Negative or Immunotherapy-Refractory Triple-Negative Breast Cancer (NADiR)

Purpose: To study the safety and anti-cancer activity of giving radiation therapy with a PARP inhibitor and a PD-1 inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) triple-negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer. You must not have received more than two systemic therapies for advanced disease and you must not have a <span class="highlight">BRCA</span> 1/2 mutation (inherited or tumor). View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Niraparib (Zejula®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®), by IV, every 3 weeks for 3 months, then every 6 weeks, ongoing</li> <li class="seamTextUnorderedListItem">Radiation therapy, 3 times, during the first week of treatment</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Breast cancer that tests positive for 1%-10% estrogen receptors is called ER Low. This trial is enrolling people with triple-negative as well as ER Low breast cancer. </li> <li class="seamTextUnorderedListItem">Niraparib (Zejula®)is a type of targeted therapy called a PARP inhibitor. It works by blocking poly (ADP-ribose) polymerase, an enzyme that helps cancer cells grow by repairing their DNA. It is considered an experimental drug in this trial. </li> <li class="seamTextUnorderedListItem">Dostarlimab (Jemperli®) is an experimental PD-1 inhibitor. </li> <li class="seamTextUnorderedListItem">PD-1 inhibitors are a type of immunotherapy also called a checkpoint inhibitor. They work by getting the immune system to go after cancer cells by blocking the PD-1 protein.</li> <li class="seamTextUnorderedListItem">An experimental therapy is a drug approved by the FDA for studying in people in clinical trials. A drug may be FDA approved for use in one disease but still considered experimental for use in breast cancer. </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">Researchers believe that radiation therapy may also boost the immune system, which will help the immune system go after and kill cancer cells.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04837209' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.bcrf.org/blog/triple-negative-breast-cancer-treatment-symptoms-research' target='_blank'>BCRF: Triple-Negative Breast Cancer: Symptoms, Treatment, Research</a> </li></ul>
24

Radiation, Immunotherapy and a PARP Inhibitor for Advanced Triple-Negative or ER Low Breast Cancer

A Phase II Study of NirAparib, Dostarlimab and Radiotherapy in Metastatic, PD-L1 Negative or Immunotherapy-Refractory Triple-Negative Breast Cancer (NADiR)
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Nearest Location:
2385 miles
Duke University Medical Center
Durham, NC

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Visits:
3 visits for the first week, then every 3 weeks for 3 months, then every 6 weeks, ongoing

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ClinicalTrials.gov: NCT04837209

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Phase II

25

Radiation Therapy, Immunotherapy, and a PARP Inhibitor for Women with Advanced Triple Negative Breast Cancer

A Phase II Study of Pembrolizumab and Ablative Radiotherapy With or Without Olaparib in Metastatic Triple-Negative Breast Cancers : Initial Test Cohorts of a Platform Trial to Sequentially Investigate Combinations of DNA-Damage Response Inhibitors and Immunotherapy for the Augmentation of Immune Responses

Purpose: To study the safety and anti-cancer activity of using radiation therapy and the immunotherapy pembrolizumab (Keytruda®) with or without the PARP inhibitor olaparib (Lynparza®).

Who is this for?: Women with advanced (some stage III) or metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer who have not already received a PARP inhibitor or more than two systemic therapies for advanced disease. To enroll, you must not have a <span class="highlight">BRCA</span> 1/2 mutation (inherited or tumor). View full eligibility criteria

What's involved?

<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">Pembrolizumab (Keytruda®), by IV, every 3 weeks, 3 times</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, twice a day, for 6 weeks</li> <li class="seamTextUnorderedListItem">Radiation therapy, daily, for five days</li> </ul> <p class="seamTextPara"> <i class="seamTextEmphasis">Group 2</i> </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®), by IV, every 3 weeks, 3 times</li> <li class="seamTextUnorderedListItem">Radiation therapy, daily, for five days</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Pembrolizumab (Keytruda®) is a type of immunotherapy called a checkpoint inhibitor or PD-1 inhibitor. It helps the immune system to go after cancer cells by blocking the PD-1 protein.</li> <li class="seamTextUnorderedListItem">Pembrolizumab is approved to treat some advanced triple-negative breast cancer, but its use in this trial, however, is considered experimental.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a PARP inhibitor. It works by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">Olaparib is approved to treat HER2-negative metastatic breast cancer in women with an inherited <span class="highlight">BRCA1/2</span> mutation. Its use in this trial, however, is considered experimental. </li> <li class="seamTextUnorderedListItem">Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04683679' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/research-news/tnbc-treatment-update-2021/' target='_blank'>Metastatic Trial Talk: 2021 Update on Metastatic Triple-Negative Breast Cancer Treatment</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mdanderson.org/cancerwise/does-immunotherapy-treat-breast-cancer.h00-159385101.html' target='_blank'>MD Anderson Cancer Center: Does Immunotherapy Treat Breast Cancer?</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.breastcancer.org/research-news/fda-approves-keytruda-for-pd-l1-pos-tnbc' target='_blank'>Breastcancer.org: FDA Approves Immunotherapy Keytruda for PD-L1-Positive Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancerresearchuk.org/about-cancer/cancer-in-general/treatment/targeted-cancer-drugs/types/PARP-inhibitors' target='_blank'>Cancer Research UK: PARP Inhibitors</a> </li></ul>
25

Radiation Therapy, Immunotherapy, and a PARP Inhibitor for Women with Advanced Triple Negative Breast Cancer

A Phase II Study of Pembrolizumab and Ablative Radiotherapy With or Without Olaparib in Metastatic Triple-Negative Breast Cancers : Initial Test Cohorts of a Platform Trial to Sequentially Investigate Combinations of DNA-Damage Response Inhibitors and Immunotherapy for the Augmentation of Immune Responses
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Nearest Location:
2539 miles
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, NJ

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Visits:
8 visits over 2 months

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ClinicalTrials.gov: NCT04683679

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Phase II

26

Stem Cells with Chemotherapy for Metastatic HER2- Breast Cancer with an Inherited <span class="highlight">BRCA1/2</span> or PALB2 Mutation

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

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

Who is this for?: People with metastatic (stage IV) HER2 negative (HER2-) breast cancer with an inherited (germline) <span class="highlight">BRCA1,</span> <span class="highlight">BRCA2,</span> or PALB2 mutation. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Granulocyte colony-stimulating factor</li> </ul> <p class="seamTextPara"> followed by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Apheresis procedure to collect stem cells</li> </ul> <p class="seamTextPara"> followed by 2 rounds of: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Melphalan, by IV</li> <li class="seamTextUnorderedListItem">Carmustine (BCNU), by IV</li> <li class="seamTextUnorderedListItem">Vitamin B12b, by IV</li> <li class="seamTextUnorderedListItem">Vitamin C, by IV</li> <li class="seamTextUnorderedListItem">Ethanol, by IV</li> </ul> <p class="seamTextPara"> followed 2 days later by: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Stem cells, by IV</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Your stem cells will be collected from your body and modified in a lab so they can identify and attack cancer cells. These modified stem cells will then be infused back into your body.</li> <li class="seamTextUnorderedListItem">Apheresis is a procedure to collect your stem cells. </li> <li class="seamTextUnorderedListItem">Granulocyte colony-stimulating factor is a drug that will help prepare your body and stem cells for apheresis.</li> <li class="seamTextUnorderedListItem">Melphalan is a chemotherapy drug.</li> <li class="seamTextUnorderedListItem">Carmustine (BCNU), vitamin B12b, vitamin C, and ethanol will be given to improve the effectiveness of the stem cell infusion.</li> <li class="seamTextUnorderedListItem">You will receive two rounds of melphalan (Alkeran®) chemotherapy and stem cell infusion approximately 6 weeks apart.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li> <li class="seamTextUnorderedListItem">Targets or mutations: <span class="highlight">BRCA1,</span> <span class="highlight">BRCA2,</span> PALB2</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04150042' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.sharontrial.com/' target='_blank'>General Oncology: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.facingourrisk.org/research-clinical-trials/study/117/a-study-of-melphalan-bcnu-vitamin-b12b-vitamin-c-and-stem-cell-infusion-in-people-with-advanced-pancreatic-cancer-and-brca-mutations' target='_blank'>Facing Our Risk of Cancer Empowered: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/tests-procedures/autologous-stem-cell-transplant/pyc-20384859' target='_blank'>Mayo Clinic: Autologous Stem Cell Transplant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/stem-cell-transplant/process.html' target='_blank'>American Cancer Society: Getting a Stem Cell Transplant</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.mayoclinic.org/drugs-supplements/melphalan-intravenous-route/side-effects/drg-20071590?p=1#:~:text=Melphalan%20injection%20is%20used%20to,alkylating%20agents%20(cancer%20medicines).' target='_blank'>Mayo Clinic: Melphalan</a> </li></ul>
26

Stem Cells with Chemotherapy for Metastatic HER2- Breast Cancer with an Inherited <span class="highlight">BRCA1/2</span> or PALB2 Mutation

SHARON: Study of Metastatic Cancers in Patients With an Inherited Defect in a Homologous Recombination Gene Using Autologous Stems Cells and Potentiated Redox Cycling to Overcome Drug Resistance to Nitrogen Mustard Derivatives
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Nearest Location:
2567 miles
Memorial Sloan Kettering Cancer Center
New York, NY

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Visits:
At least 6 visits, may require hospitalization

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ClinicalTrials.gov: NCT04150042

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Phase I

27

Axatilimab Immunotherapy with Targeted Therapy for Metastatic HER2 Negative Breast Cancer with <span class="highlight">BRCA1/2</span> or PALB2 Mutations

Phase Ib Study of Axatilimab in Combination With Olaparib in <span class="highlight">BRCA1/2</span> and PALB2- Associated Metastatic HER2-negative Breast Cancer

Purpose: To study the safety, best dose, and effects (good and bad) of axatilimab, an experimental immunotherapy, with olaparib (Lynparza®) PARP inhibitor.

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) HER2 negative (HER2-) or HER2 low breast cancer with tumor or inherited <span class="highlight">BRCA1</span> or <span class="highlight">BRCA2</span> mutations or inherited PALB2 mutations. You must not have received more than 2 lines of chemotherapy, antibody drug conjugates (ADC), and/or immunotherapy for advanced disease. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Axatilimab, by IV, every 2 weeks</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®), by mouth, daily</li> <li class="seamTextUnorderedListItem">MRI and/or CT scans, every 2 months</li> <li class="seamTextUnorderedListItem">Electrocardiograms</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Axatilimab is an experimental immunotherapy drug that may help the immune system go after and kill cancer drugs.</li> <li class="seamTextUnorderedListItem">Axatilimab is approved to treat Graft-Versus-Host Disease (GVHD), and its use in this trial is considered experimental.</li> <li class="seamTextUnorderedListItem">Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA.</li> <li class="seamTextUnorderedListItem">A magnetic resonance imaging (MRI) scan produces body pictures created by using magnetic energy rather than x-ray energy.</li> <li class="seamTextUnorderedListItem">A computed tomography (CT) scan produces body pictures created by x-ray energy.</li> <li class="seamTextUnorderedListItem">An electrocardiogram (ECG) test records electrical signals in your heart.</li> <li class="seamTextUnorderedListItem">In this trial, HER2 low is defined as IHC 1+ or IHC 2+/ISH-.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT06488378' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.dana-farber.org/clinical-trials/24-155' target='_blank'>Dana-Farber Cancer Institute: Trial Information Page</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/axatilimab' target='_blank'>National Cancer Institute: Axatilimab</a> </li></ul>
27

Axatilimab Immunotherapy with Targeted Therapy for Metastatic HER2 Negative Breast Cancer with <span class="highlight">BRCA1/2</span> or PALB2 Mutations

Phase Ib Study of Axatilimab in Combination With Olaparib in <span class="highlight">BRCA1/2</span> and PALB2- Associated Metastatic HER2-negative Breast Cancer
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Nearest Location:
2693 miles
Dana-Farber Cancer Institute
Boston, MA

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Visits:
1 visit every 2 weeks

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ClinicalTrials.gov: NCT06488378

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Phase I

28

Sacituzumab Govitecan and Talazoparib for Women With Metastatic Triple Negative Breast Cancer

Phase 1b/2 Study to Evaluate Antibody-Drug Conjugate Sacituzumab Govitecan in Combination With PARP Inhibitor Talazoparib in Patients With Metastatic Breast Cancer

Purpose: To evaluate the safety, best dose, and effects (good and bad) of using PARP inhibitor talazoparib (Talzenna®) in combination with sacituzumab govitecan (Trodelvy).

Who is this for?: Women with metastatic (stage IV) triple negative (ER-, PR-, HER2-) breast cancer. View full eligibility criteria

What's involved?

<p class="seamTextPara"> You will receive the following: </p> <ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">Talazoparib (Talzenna®), by mouth, daily, ongoing</li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy), by IV, once a week, for 2 out of every 3 weeks, ongoing</li></ul>

What's being studied?

<ul class="seamTextUnorderedList"> <li class="seamTextUnorderedListItem">The PARP inhibitor being used in this study is talazoparib (Talzenna®). It is approved for use in individuals with advanced triple-negative breast cancer and an inherited <span class="highlight">BRCA1</span> or <span class="highlight">BRCA2</span> mutation. </li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is an antibody-drug conjugate (ADC). This means it uses an antibody that targets cancer cells to deliver a chemotherapy directly to these cells. </li> <li class="seamTextUnorderedListItem">The antibody in this drug targets TROP2 proteins. </li> <li class="seamTextUnorderedListItem">It delivers the chemotherapy irinotecan. Irinotecan is approved for use in many other types of cancer. </li> <li class="seamTextUnorderedListItem">Sacituzumab govitecan (Trodelvy) is approved to treat some metastatic triple-negative breast cancer, but its use in this trial is considered experimental.</li></ul>

How can I learn more?

<ul class='seamTextUnorderedList'><li class='seamTextUnorderedListItem'>View eligibility criteria and additional trial information: <a href='https://clinicaltrials.gov/ct2/show/NCT04039230' target='_blank'>ClinicalTrials.gov</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.cancer.gov/publications/dictionaries/cancer-drug/def/sacituzumab-govitecan' target='_blank'>NCI Drug Dictionary: Sacituzumab Govitecan</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.ascopost.com/news/april-2020/fda-approves-sacituzumab-govitecan-hziy-for-patients-with-previously-treated-metastatic-triple-negative-breast-cancer/' target='_blank'>ASCO: FDA Approves Sacituzumab Govitecan-hziy for Patients With Previously Treated Metastatic Triple-Negative Breast Cancer</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.immunomedics.com/sacituzumab-govitecan-immu-132/' target='_blank'>Immunomedics Drug Information Page: Trodelvy (Sacituzumab Govitecan)</a> </li><li class='seamTextUnorderedListItem'><a href='https://www.talzenna.com/?source=google&HBX_PK=s_talazoparib&skwid=43700039109819878' target='_blank'>Pfizer Oncology: Talzenna™</a> </li><li class='seamTextUnorderedListItem'><a href='https://metastatictrialtalk.org/2019/05/01/mbc-news-11/' target='_blank'>Metastatic Trial Talk: ADCs in Breast Cancer</a> </li></ul>
28

Sacituzumab Govitecan and Talazoparib for Women With Metastatic Triple Negative Breast Cancer

Phase 1b/2 Study to Evaluate Antibody-Drug Conjugate Sacituzumab Govitecan in Combination With PARP Inhibitor Talazoparib in Patients With Metastatic Breast Cancer
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Nearest Location:
2693 miles
Massachusetts General Hospital Cancer Center
Boston, MA

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Visits:
Weekly visits for 2 out of every 3 weeks

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ClinicalTrials.gov: NCT04039230

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Phase I-II

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