Clinical Trials /

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

NCT03964532

Description:

This is a multi-institutional pilot trial for patients with advanced breast cancer. The trial is designed to assess the safety and tolerability of induction talazoparib followed by combination of talazoparib and avelumab. As an exploratory endpoint, the study team will evaluate the immunomodulatory effects of induction talazoparib followed by the combination of talazoparib and avelumab in patients with advanced breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: STUDY00000023
  • NCT ID: NCT03964532

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
TalazoparibTalzennaPhase I/Phase II
AvelumabBavencioPhase I/Phase II

Purpose

This is a multi-institutional pilot trial for patients with advanced breast cancer. The trial is designed to assess the safety and tolerability of induction talazoparib followed by combination of talazoparib and avelumab. As an exploratory endpoint, the study team will evaluate the immunomodulatory effects of induction talazoparib followed by the combination of talazoparib and avelumab in patients with advanced breast cancer.

Trial Arms

NameTypeDescriptionInterventions
Phase I/Phase IIExperimentalTalazoparib (1mg by mouth [PO] daily D1-28) will be provided as monotherapy for the first cycle. Starting with cycle 2 and for all subsequent cycles, treatment with avelumab (800 mg intravenously [IV] D1 every 2 weeks) will be added to talazoparib.
  • Talazoparib
  • Avelumab

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed advanced breast cancer not amenable to curative treatment by
             surgery or radiotherapy, that is amenable to biopsy

          -  Radiographically measurable disease by RECIST v1.1

          -  Age ≥ 18 years

          -  Life expectancy of more than 3 months

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1

          -  Signed informed consent form

          -  Adequate hepatic, bone marrow, and renal function as defined below in the body of the
             protocol

        Exclusion Criteria:

          -  Prior exposure to PARP inhibitor-based therapy

          -  Prior disease progression while receiving anti-PD-1 or anti-PD-L1 therapy within 6
             months of use

          -  Recent severe infection or antibiotic use, or known chronic infection with human
             immunodeficiency virus (HIV) or hepatitis B virus

          -  Diagnosis of immunodeficiency or is receiving systemic steroid or other
             immunosuppressive therapy

          -  Active autoimmune disease that has required systemic treatment in the past 2 years

          -  History of tuberculosis

          -  History of allogenic bone marrow transplant or solid organ transplant

          -  Live vaccine administration within 30 days of planned start of study therapy

          -  Cardiovascular disease problems including unstable angina, therapy for lifethreatening
             ventricular arrhythmia, or myocardial infarction, stroke within the last 6 months, or
             a diagnosis of congestive heart failure

          -  Women who are pregnant or breastfeeding

          -  Patients with known untreated central nervous system (CNS) metastases

          -  Patients with history of another active malignancy within the past 2 years, excluding
             non-melanoma carcinoma of the skin

          -  Patients receiving any other investigational agents
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:The number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Time Frame:28 Days
Safety Issue:
Description:Toxicity analysis will be conducted in all patients receiving at least one dose of talazoparib.

Secondary Outcome Measures

Measure:The anti-tumor efficacy as measured by Overall Response Rate (ORR).
Time Frame:4 Months
Safety Issue:
Description:The distributions of OS will be estimated using the Kaplan-Meier method.

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Georgetown University

Trial Keywords

  • Breast Cancer
  • Advanced Breast Cancer
  • Talazoparib
  • Avelumab

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