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- PARP Inhibitors

Istodax and Platinol for Advanced BRCA+ or Triple Negative Breast Cancer

Phase I/II Trial of Cisplatin Plus Romidepsin in Locally Recurrent or Metastatic Triple Negative Breast Cancer or BRCA1 or BRCA2 Mutation Associated Locally Recurrent or Metastatic Breast Cancer. (NCT02393794)

Summary

Romidepsin (Istodax®) is an FDA-approved drug that is currently used to treat a type of lymphoma. Laboratory studies suggest Istodax may also be effective for treating breast cancer. Cisplatin (Platinol®) is a platinum-based chemotherapy drug that studies suggest is effective for treating triple-negative breast cancer. In the first phase of the study, researchers will determine the highest dose of Istodax that can safely and tolerably be used in combination with Platinol. In phase II, this highest dose will be given along with Platinol. Both phases of the study will enroll women with advanced breast cancer who are known to carry a BRCA mutation or who have triple negative breast cancer.


This is a Phase I-II trial

Platinol plus Veliparib for Recurrent or Metastatic HER2- Breast Cancer

Phase II Randomized Placebo-Controlled Trial of Cisplatin With or Without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer and/or BRCA Mutation-Associated Breast Cancer (NCT02595905)

Summary

Cisplatin (Platinol®) is a chemotherapy drug used to treat metastatic breast cancer. Researchers want to know if Platinol kills more cancer cells when it is given alone or with other drugs. In this study, researchers will see if Platiniol works better when it is given with veliparib. This drug is a new type of targeted treatment called a PARP inhibitor. To take part in this study, you must have metastatic triple negative (ER-, PR- and HER2-) breast cancer or have an inherited BRCA mutation and metastatic HER2-negative breast cancer.


This is a Phase II trial

BGB-290 with Temozolomide for Advanced Breast (and Other) Cancer

A Phase 1b Study to Assess the Safety, Tolerability and Clinical Activity of BGB-290 in Combination With Temozolomide (TMZ) in Subjects With Locally Advanced or Metastatic Solid Tumors (NCT03150810)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. This study will investigate the safety and effects (good or bad) of using an oral chemotherapy along with a new targeted drug to treat advanced breast cancer. The two drugs being used in this study are temozolomide (Temodar) and BGB-290. Temodar is used to treat brain cancer. BGB-290 is a type of targeted therapy called a PARP inhibitor.


This is a Phase I-II trial

Talazoparib for HER2-Negative Advanced Breast Cancer

A Phase II Clinical Trial of BMN 673 in BRCA1 and BRCA2 Wild-Type Patients With (i) Advanced Triple-Negative Breast Cancer and Homologous Recombination Deficiency as Assessed by the HRD Assay, and (ii) Advanced HER2-Negative Breast Cancer With Either a Germline or Somatic Mutation in... (NCT02401347)

Summary

Talazoparib (BMN 673) is a PARP inhibitor. Studies suggest PARP inhibitors may be effective in some types of breast cancer. Early studies suggest talazoparib may be effective in cancer patients who have an inherited BRCA1/2 mutation. It may also be effective in patients who do not have a BRCA1/2 mutation. This study is investigating the safety and effectiveness of talazoparib in patients with HER2-negative advanced breast cancer who do not have a BRCA1/2 mutation. To be eligible, participants must have advanced triple negative breast cancer or HER2-negative breast cancer with a mutation in another gene. Participants will have their tumor tested for genetic mutations to determine eligibility.


This is a Phase II trial

Lynparza and Onalespib for Metastatic Triple Negative Breast Cancer

A Phase 1 Study of PARP Inhibitor Olaparib and HSP90 Inhibitor AT13387 for Treatment of Advanced Solid Tumors With Expansion in Patients With Recurrent Epithelial Ovarian, Fallopian Tube, Peritoneal Cancer, or Recurrent Triple-Negative Breast Cancer (NCT02898207)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) metastatic (stage IV) breast cancer. This study will determine the safety and best dose of two targeted drugs for treating metastatic breast cancer. The two targeted drugs being used in this study are olaparib (Lynparza®) and onalespib (AT13387). Lynparza is a PARP inhibitor. It is approved by the FDA to treat ovarian cancer. Onalespib is an experimental HSP90 inhibitor. This trial is also enrolling patients with other types of cancers.


This is a Phase I trial

Prexasertib and Lynparza in Patients With Advanced Breast (and Other) Cancer

A Basket Study: Phase 1 Combination Study of Prexasertib (LY2606368), CHK1 Inhibitor, and Olaparib, PARP Inhibitor, in Patients With Advanced Solid Tumors (NCT03057145)

Summary

To take part in this study, you must have advanced (stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good and bad) of using two types of targeted drugs to treat advanced breast cancer. The two drugs being used are Lynparza and prexasertib (LY2606368). Lynparza is approved by the FDA for the treatment of ovarian cancer. Laboratory studies suggest giving prexasertib with Lynparza will make Lynparza more effective. This study is also recruiting patients with other types of cancer.


This is a Phase I trial

Selumetinib and Lynparza for Advanced Breast (and Other) Cancer

Evaluation of the Combination of Selumetinib and Olaparib in Endometrial, Ovarian and Other Solid Tumors With Ras Pathway Alterations, and Ovarian Tumors With PARP Resistance (NCT03162627)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating whether it is safe and effective to use the drug selumetinib along with olaparib (Lynparza®) to treat advanced breast cancer. Selumetinib (AZD6244) is an experimental targeted drug called an MEK inhibitor. Olaparib (Lynparza®) is a type of targeted drug called a PARP inhibitor. It is approved to treat certain types of ovarian cancer. This study is also recruiting individuals with other types of cancer.


This is a Phase I trial

Cediranib + Lynparza for Metastatic Triple Negative Breast Cancer (and Other Solid Tumors)

A Phase 2 Study of Cediranib in Combination With Olaparib in Advanced Solid Tumors (NCT02498613)

Summary

This trial is studying the safety and effectiveness of treating metastatic breast cancer (and other solid tumors) with two drugs: Olaparib (Lynparza®) and Cediranib. To take part, you must have metastatic triple negative breast cancer and not have an inherited BRCA 1/2 mutation. Olaparib (Lynparza®) is a type of targeted therapy called a PARP inhibitor. Cediranib is a type of drug called an angiogenesis inhibitor. Giving cediranib with Lynparza may make the Lynparza more effective.


This is a Phase II trial

A New PARP Inhibitor For BRCA-Positive Advanced Breast Cancer

Pilot Trial of BMN 673, an Oral PARP Inhibitor, in Patients With Advanced Solid Tumors and Deleterious BRCA Mutations (NCT01989546)

Summary

BMN 673 is a new type of cancer drug called a PARP inhibitor. It works by blocking the PARP —poly (ADP-ribose) polymerase—protein that helps cells repair DNA damage. Early studies suggest BMN 673 may be effective in patients with advanced breast cancer who have a BRCA mutation. This study is evaluating the effect that BMN673 has on cancer cells (through tumor biopsies) of patients with advanced breast cancer who have a known BRCA inherited mutation.


This is a Phase I-II trial

Radiation and Veliparib After Chemotherapy and Before Surgery

Pre-Operative PARPi and Irradiation (POPI) in Women With an Incomplete Response to Neo-Adjuvant Chemotherapy for Breast Cancer (NCT01618357)

Summary

Giving chemotherapy before surgery (called neoadjuvant therapy) allows doctors to see how the tumor responds to the treatment. It can also shrink the tumor, which may permit a woman to have a lumpectomy instead of a mastectomy. About 20-30 percent of the time, the breast tumor will completely disappear, making it less likely to recur. Veliparib is a type of new cancer treatment called a PARP inhibitor. Laboratory studies have shown that it can make the tumor more likely to respond to radiation and chemotherapy. This study is investigating the safety of combining radiation and Veliparib in women with stage II or III breast cancer whose tumors do not completely disappear after neoadjuvant chemotherapy.


This is a Phase I trial

Olaparib for Metastatic Breast Cancer with an Inherited Genetic Mutation

A Phase 2 Study of Olaparib Monotherapy in Metastatic Breast Cancer Patients With Germline or Somatic Mutations in DNA Repair Genes (Olaparib Expanded) (NCT03344965)

Summary

To take part in this study, you must have metastatic (stage IV) breast cancer and have an inherited DNA repair gene mutation that was identified through genetic testing of the tumor or through a blood test. This study is investigating whether olaparib (Lynparza®) is effective for treating metastatic breast cancer in women and men with a tumor that has a DNA repair gene mutation, such as BRCA1 or BRCA2. Olaparib (Lynparza®) is a type of targeted therapy known as a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. Lynparza is currently approved to treat recurrent ovarian cancer and HER2-negative metastatic breast cancer.


This is a Phase II trial

Lynparza Alone or With a New Drug That Targets DNA Repair in Metastatic TNBC

A Phase II, Open Label, Randomised, Multi-centre Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination With Olaparib Versus Olaparib Monotherapy in the Treatment of Metastatic Triple Negative Breast Cancer Patients Stratified by Alterations in Homologous Recombinant... (VIOLETTE) (NCT03330847)

Summary

To take part in this study you must have metastatic triple negative breast cancer that has been treated with up to two other drug therapies. Also, your tumor must have a mutation in genes that are part of the homologous recombination repair (HRR) pathway, which includes BRCA 1/2. Your tumor will be tested for mutations in these genes as part of the screening process. This study will compare the safety and effects (good and bad) of using olaparib (Lynparza®) alone to using Lynparza along with a new drug that targets DNA repair. Lynparza is a type of drug called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. The experimental drugs used in this study, AZD6738 and AZD1775, also target DNA damage repair.


This is a Phase II trial

  • Participation Time5 initial visits, then 1 visit every 2 months for 18 months, then 1 visit every 3 months
  • Participating research sites
    Research sites: 19 sites total

Radiation Therapy With or Without Olaparib For Inflammatory Breast Cancer

A Phase II Randomized Trial of Olaparib (NSC-747856) Administered Concurrently With Radiotherapy Versus Radiotherapy Alone for Inflammatory Breast Cancer (SWOG 1706) (NCT03598257)

Summary

To take part in this study you must be a woman with stage III inflammatory breast cancer.

This study is comparing the benefits and the effects (good and bad) of using radiation therapy along with a PARP inhibitor to radiation therapy alone. The PARP inhibitor being used in this study is olaparib (Lynparza®). It is approved to treat HER2-negative metastatic breast cancer in women with a BRCA genetic mutation. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors.


This is a Phase II trial

Zejula Before Surgery for HER2-Negative BRCA+ Breast Cancer

An Open-Label, Single-arm Pilot Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Localized, HER2-negative, BRCA-mutant Breast Cancer Patients (NCT03329937)

Summary

To take part in this study, you must have HER2-negative early stage (stage I-III) breast cancer, have tested positive for a BRCA1 or BRCA2 mutation. This study is investigating the safety and effects (good and bad) of a targeted therapy for HER2-negative breast cancer. In this study, the drug is given before surgery. This is called neoadjuvant treatment. Giving the drug before surgery allows doctors to study the effect the treatment has on the tumor. The targeted therapy is niraparib (Zejula®). It is a PARP inhibitor. These drugs work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. It is approved to treat women with certain types of reproductive cancers whose tumors responded to a platinum-based chemotherapy. Its use in breast cancer is considered experimental.


This is a Phase I trial

Talazoparib for Advanced Breast (and Other) Cancer with BRCA1/2 or Other Genetic Changes

Phase II Study of the PARP Inhibitor BMN 673 (Talazoparib Tosylate) in Advanced Cancer Patients With Somatic Alterations in BRCA1/2, Mutations/Deletions in PTEN or PTEN Loss, a Homologous Recombination Defect, Mutations/Deletions in Other BRCA Pathway Genes and Germline Mutation in BRCA1/2 (Not Breast or Ovarian Cancer) (NCT02286687)

Summary

To take part in this study, you must have advanced (some stage III) or metastatic (stage IV) breast cancer and certain genetic alterations or mutations, including the BRCA1/2 mutations. This study is investigating whether the drug talazoparib helps treat women and men with advanced breast cancer who have certain genetic mutations or deletions, including BRCA1/2 mutations. The safety of this drug will also be studied. Talazoparib (BMN 673) is only available through clinical trials. It is a type of drug called a PARP inhibitor. It works by preventing the PARP protein from repairing damaged DNA in tumor cells.


This is a Phase II trial

Personalized Treatment Before Surgery: The I-SPY 2 Trial

I-SPY 2 Trial (Investigation of Serial Studies to Predict Your Therapeutic Response With Imaging And moLecular Analysis 2) (NCT01042379)

Summary

Targeted therapy is an active area of breast cancer research in which treatment is tailored to an individual's tumor type. The goal of this trial is to determine whether standard chemotherapy can be made more effective by adding investigational drugs that target specific tumor characteristics. All treatment will be given prior to surgery (neoadjuvant therapy), enabling researchers to directly evaluate how well the tumor is responding. The information that researchers gain from each participant will be used to help decide which treatments should be given to women who join the trial at a later date. By designing the trial in this way, researchers will learn more quickly which investigational drugs will be most beneficial for women with certain tumor characteristics.


This is a Phase II trial

Olaparib After Chemo for BRCA+ HER2-Negative Stage I-III Breast Cancer

A Randomised, Double-blind, Parallel Group, Placebo-controlled Multi-centre Phase III Study to Assess the Efficacy and Safety of Olaparib Versus Placebo as Adjuvant Treatment in Patients With gBRCA1/2 Mutations and High Risk HER2 Negative... (OlympiA trial) (NCT02032823)

Summary

Olaparib (Lynparza) is a new type of drug called a PARP inhibitor. PARP inhibitors work by blocking the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. In tumor cells in women with a BRCA mutation, blocking this enzyme can lead to cell death. In Dec. 2014, Lynparza was approved for treating advanced ovarian cancer in women with a BRCA mutation. Prior studies suggest breast cancer that develops in patients with a BRCA mutation will also respond to Lynparza. This study is comparing the safety and effectiveness of Lynparza to a placebo in women with a BRCA mutation who have had surgery and neoadjuvant or adjuvant chemotherapy to treat early-stage HER2-negative breast cancer.


This is a Phase III trial

Avelumab Plus Talazoparib to Treat Advanced Breast Cancer

A Phase 1b/2 Study To Evaluate Safety And Anti Tumor Activity Of Avelumab In Combination With The Poly(Adenosine Diphosphate [Adp]-Ribose) Polymerase (Parp) Inhibitor Talazoparib In Patients With Locally Advanced Or Metastatic Solid Tumors (NCT03330405)

Summary

To take part in this study, you must have triple negative (ER-/PR-/HER2-) or HR+, locally advanced (some stage III) or metastatic (stage IV) breast cancer. This study is investigating the safety and effects (good or bad) of using an immunotherapy along with a targeted therapy to treat advanced breast cancer. The immunotherapy being used in this study is abelumab (Bavencio®). It works by blocking a protein called PD-L1 (programmed cell death-ligand 1). Talazoparib (BMN-637) is a type of targeted therapy called a PARP inhibitor. It prevents the PARP protein from repairing damaged DNA in tumor cells. This study is also enrolling patients with other types of solid tumors.
This is a Phase II trial

Durvalumab & Olaparib in Advanced Triple Negative Breast Cancer Treated with Chemotherapy

Phase II Multicenter Study of Durvalumab and Olaparib in Platinum tReated Advanced Triple Negative Breast Cancer (DORA) (NCT03167619)

Summary

To take part in this study, you must have advanced (some stage III that is inoperable) or metastatic (stage IV) triple negative breast cancer (ER-, PR- and HER2-), have already been treated with at least three cycles of a platinum-based chemotherapy and shown response, and have had no more than two prior chemotherapy regimens for metastatic breast cancer.

This study will compare the effects (good or bad) of using the targeted therapy olaparib (Lynparza®) alone or with an immunotherapy drug. Lynparza is approved to treat HER2-negative metastatic breast cancer in patients who test positive for an inherited BRCA mutation. It is a PARP inhibitor, a drug that blocks the action of poly (ADP-ribose) polymerase, an enzyme that helps repair DNA. Durvalumab (Imfinzi®) is a type of immunotherapy called a PD-L1 (programmed cell death ligand-1) inhibitor. It has been approved to treat certain other types of cancers, and its use in breast cancer is considered experimental.


This is a Phase II trial

MEDI4736 with Lynparza or Cediranib for Advanced Breast (and Other Solid) Tumors

Phase I/II Study of the Anti-Programmed Death Ligand-1 Antibody MEDI4736 in Combination With Olaparib or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Cancer (NCT02484404)

Summary

MEDI4736 (durvalumab) is an immunotherapy drug that works by blocking a protein called PD-L1 (programmed cell death ligand-1). Blocking this protein allows the body's immune system to go after cancer cells. Olaparib (Lynparza®) is a type of cancer drug called a PARP inhibitor. PARP inhibitors interfere with the cancer cells' DNA, making them more sensitive to chemotherapy. Lynparza is used to treat advanced ovarian cancer in women who have an inherited BRCA1/2 mutation. In phase 1 of this study, researchers studied the safety and effectiveness of using MEDI4736, Lynparza or cediranib to treat advanced breast (and other solid) tumors. Phase 1 is now completed. Phase 2 of this study is open to triple-negative breast cancer patients combining MEDI4736 and olaparib. To be eligible, patients must not have previously been treated with PARP inhibitors, PD-1 or PD-L1 inhibitor or an anti-CTLA4 therapy and not have had more than 3 lines of previous treatments for metastatic disease.


This is a Phase I-II trial

Treating Advanced Cancer By Choosing Targeted Therapy Based on Tumor's Genetic Makeup

A Basket Study: Targeted Agent and Profiling Utilization Registry (TAPUR) Study (NCT02693535)

Summary

This study is evaluating the safety and effectiveness of using the tumor's genetic alterations to select an FDA-approved targeted therapy for treatment. In this study, the targeted therapy each patient receives will be selected based on their tumor's specific genetic profile. To be eligible, individuals must have no available standard therapy options. This study is enrolling patients with advanced breast and other cancers.

MEDI4736 & Lynparza in Metastatic HER2- Breast Cancer in Women with a BRCA Mutation

A Phase I/II Study of MEDI4736 (Anti-PD-L1 Antibody) in Combination With Olaparib (PARP Inhibitor) in Patients With Advanced Solid Tumors (NCT02734004)

Summary

Olaparib (Lynparza) is a new type of targeted therapy called a PARP inhibitor. It works by blocking the PARP protein from repairing damaged DNA in cancer cells. Lynparza is approved for treating advanced ovarian cancer in women with a BRCA mutation. MEDI4736 is an immunotherapy that blocks PD-L1 (programmed cell death-ligand 1) protein. Blocking this protein stimulates the immune system to go after cancer cells. This study is investigating the safety and effectiveness of using Lynparaza and MEDI4736 together to treat women with HER2-negative metastatic breast cancer who have a BRCA1 or BRCA2 mutation.


This is a Phase I-II trial

Veliparib and/or Tecentriq for BRCA+, Stage III-IV Triple Negative Breast Cancer

A Phase II Multiple-Arm, Open-Label, Randomized Study of PARP Inhibition (Veliparib; ABT-888) and Anti-PD-L1 Therapy (Atezolizumab; MPDL3280A) Either Alone or in Combination in Homologous DNA Repair (HDR) Deficient Triple Negative Breast Cancer (TNBC) (NCT02849496)

Summary

To take part in this study, you must have stage III or IV triple negative (ER-/PR-/HER2-) breast cancer. You must also test positive for the inherited BRCA1/2 mutation. This study is investigating how well two different types of cancer drugs work when they are used alone or together to treat stage III or IV triple negative breast cancer. The two drugs being used in this study are Veliparib (ABT-888) and atezolizumab (Tecentriq). Veliparib (ABT-888) is a new type of targeted drug called a PARP inhibitor. It is available only in clinical trials. Tecentriq is a new immunotherapy drug. It is approved to treat bladder cancer and a type of lung cancer.


This is a Phase II trial

Olaparib and Durvalumab for Metastatic Triple Negative Breast Cancer

A Pilot Study of Olaparib and Durvalumab in Patients With Metastatic Triple Negative Breast Cancer (NCT03544125)

Summary

To take part in this study, you must have metastatic (stage IV) triple negative (ER-/PR-/HER2-) breast cancer. You must not have had prior treatment with anti-PD-L1, anti-PD-1, anti-CTLA4 therapies or PARP inhibitors. This study is investigating the effects of using a targeted therapy followed by an immunotherapy to treat metastatic triple negative breast cancer. The targeted therapy being used is the PARP inhibitor olaparib (Lynparza®). It is approved to treat BRCA+, HER2- breast cancer. The immunotherapy being used in this study is durvalumab (Imfinzi®). It works by stimulating the body's immune system to go after cancer cells. It is approved to treat certain types of lung cancer.
This is a Phase I trial