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.
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
Interventions
Drug | Synonyms | Arms |
---|
Talazoparib | Talzenna | Phase I/Phase II |
Avelumab | Bavencio | Phase 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
Name | Type | Description | Interventions |
---|
Phase I/Phase II | Experimental | Talazoparib (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. | |
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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