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1

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, BRCA1/2, CDK4, CDK6, CDKN2A, CSF1R, FGFR1/2/3/4, HER2 (ERBB2), high mutational load and others, KIT, MET, MSI-H, mTOR, NRG1, PALB2, PDGFR, POLD1, POLE, RAF-1, RET, ROS1, TSC, VEGFR</li></ul>

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>
1

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:
2 miles
Sutter Cancer Research Consortium
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

2

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 BRCA1, BRCA2, PALB2, RAD51C, or RAD51D mutation. You must not have received treatment with a PARP inhibitor. You must have at least 1 tumor that has not been treated with radiation. 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: BRCA1, BRCA2, 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>
2

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:
5 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

3

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

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

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

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer with a BRCA1, BRCA2, ATM, and/or PALB2 mutation. 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: BRCA1, BRCA2, 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>
3

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

Combination Therapy of Niraparib and Irinotecan in Cancers With Mutations in DNA Repair Genes
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Nearest Location:
5 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

4

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 BRCA1/2 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>
4

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:
29 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

5

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

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

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

Who is this for?: People with advanced (some stage III) or metastatic (stage IV) breast cancer who have a BRCA2 or PALB2 germline (genetic) mutation. 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: BRCA2, 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>
5

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

Phase Ib Expansion Study of CX-5461 in Patients With Solid Tumours and BRCA2 and/or PALB2 Mutation
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Nearest Location:
341 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

6

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 BRCA1, BRCA2, 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>
6

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:
595 miles
START Mountain Region
West Valley City, UT

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Visits:
Number of visits unavailable

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ClinicalTrials.gov: NCT06253130

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Phase I-II

7

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

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

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

Who is this for?: People with inherited BRCA1/2 mutations or certain other genetic mutations (see list below) and people with stage I, stage II, stage III, or stage IV triple negative (ER-, PR-, HER2-) or ER Low (1%-10% ER) breast cancer. 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 BRCA1 and BRCA2 mutations. </li> <li class="seamTextUnorderedListItem">Targets or mutations: BRCA1, BRCA2, 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>
7

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

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

8

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

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>
8

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

9

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 BRCA1, BRCA2, 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, BRCA2, PALB2, ATM, ATR, CHEK2, FANCA, MLH1, MRE11A, NBN, RAD51C, CDK12, are types of homologous recombination repair (HRR) or homologous recombination deficiency (HRD) mutations.</li> <li class="seamTextUnorderedListItem">This trial is also enrolling people with other types of cancer.</li></ul>

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>
9

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:
1482 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

10

Niraparib and Dostarlimab for Metastatic Triple-Negative or BRCA1/2 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 BRCA1/2 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>
10

Niraparib and Dostarlimab for Metastatic Triple-Negative or BRCA1/2 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:
1644 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

11

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

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

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

Who is this for?: People with metastatic (stage IV) HER2 negative (HER2-) breast cancer with an inherited (germline) BRCA1, BRCA2, or PALB2 mutation. 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: BRCA1, BRCA2, 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>
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Stem Cells with Chemotherapy for Metastatic HER2- Breast Cancer with an Inherited BRCA1/2 or PALB2 Mutation

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

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