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TALAVE: Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer

TALAVE: Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer

Clinicaltrials.gov identifier:
NCT03964532

Treatment:
Breast

Study Contact Information:

For more information about the study, please contact the Project Managers:

Nicole Swanson by email or Eunice Shim by email.


TALAVE: A Pilot Trial of Induction Talazoparib Followed by Combination of Talazoparib and Avelumab in Advanced Breast Cancer

About the Study

TALAVE is a study for patients who have advanced or metastatic breast cancer that will not be cured by treatment with surgery or radiotherapy, and either have a BRCA1/2 mutation (germline or somatic) or have triple negative breast cancer who are not known to have a BRCA1/2 mutation. The goal of TALAVE is to look at whether giving talazoparib alone followed by talazoparib with avelumab is a safe and effective treatment for advanced breast cancer.

Type of Study

TALAVE is an open-label, multicenter, pilot study evaluating the safety and efficacy of induction talazoparib followed by combination of talazoparib and avelumab in patients with advanced breast cancer. Response to treatment will be evaluated with imaging (usually CT scans).

  • This is an open label study, which means that all participants will receive the same investigational medications and they will know the medications they are getting.
    • The investigational treatment is talazoparib alone for the first cycle, followed by combination of talazoparib with avelumab until progression.

What the Study Entails

  • Patients with advanced breast cancer and either have a BRCA1/2 mutation or have triple negative breast cancer who are not known to have a BRCA1/2 mutation will qualify for the study if they have disease that is measurable and can be biopsied.
  • Talazoparib is an oral medication that will be administered by mouth daily on days 1 through 28 of each 28 day cycle.
  • Avelumab will be started after the first cycle of talazoparib and will be given through an IV on days 1 and 15 starting in the second cycle.
  • The combination treatment will then continue until it is no longer helping you, either because the tumor is no longer responding or you developed toxicities to any of the treatment drugs.
  • Participants will complete drug diaries.
  • Blood samples will be taken for research purposes before the treatment is started and during the study on cycle 1 day 15 and cycle 2 day 15.
  • Biopsies will be done (or tissue obtained) before starting the treatment, at the end of the first cycle, and at the end of the second cycle for research purposes. Patients who show benefit from the treatment and later have progression of disease may have a biopsy at the time of progression for research studies.
  • Study drugs and biopsies are paid for by the study.
  • Participants will be monitored for safety with blood tests, clinic visits, and physical exams every 2 weeks on days 1 and 15 of each cycle for the first 4 cycles, and then will transition to every 4 week evaluations on day 1 of each cycle.
  • Imaging (such as CT scans) will occur every 8 weeks.

Study Sites

  • District of Columbia
    • Washington, DC: Georgetown University, Lombardi Comprehensive Cancer Center
      Contact: Natalie Salsini by phone at: (202) 687-9016 or by email.
  • Utah
    • Salt Lake City, Utah: University of Utah, Huntsman Cancer Institute
      Contact: Janna Espinosa by phone at: (801)585-0571 

 

This Study is Open To:

People may participate if they:

  • either have a BRCA1/2 mutation (germline or somatic) or have triple negative breast cancer who are not known to have a BRCA1/2 mutation
  • have measurable disease (this will be determined by your doctor)
  • have tumor that is amenable to biopsies
This Study is Not Open To:

People cannot participate if they: 

  • have received previous treatment with a PARP inhibitor
  • previously did not respond to anti-PD-1 or anti-PD-L1 therapies
  • have had a recent severe or known chronic infection (HIV, Hepatitis B)
  • have an active autoimmune disease or immunodeficiency
  • have a history of allogenic bone marrow or solid organ transplant
  • received a live vaccine within 30 days of start of study therapy
  • have heart problems including unstable angina, treatment for life-threatening cardiac rhythms, or myocardial infarction, stroke within the last 6 months, or a diagnosis of congestive heart failure
  • are pregnant or breastfeeding
  • have known untreated central nervous system (CNS) metastases; stable, treated CNS metastases are allowed
  • were diagnosed with another malignancy within the past 2 years, excluding nonmelanoma carcinoma of the skin
  • are receiving any other investigational agents