Olaparib and Durvalumab in Treating Patients With Metastatic Triple Negative Breast Cancer

Summary

Participation Requirements

Description

PRIMARY OBJECTIVE: I. Assess overall response to treatment. SECONDARY OBJECTIVES: I. Assess participant benefit from treatment. II. Determine the time to disease progression following response to study therapy. III. Determine time to first disease progression or death of participants enrolled on the...

PRIMARY OBJECTIVE: I. Assess overall response to treatment. SECONDARY OBJECTIVES: I. Assess participant benefit from treatment. II. Determine the time to disease progression following response to study therapy. III. Determine time to first disease progression or death of participants enrolled on the study. IV. Determine survival of participants enrolled on the study. V. Assess safety and tolerability of the proposed therapy. EXPLORATORY OBJECTIVES: I. Examine response rates depending on tumor characteristics. II. Identify predictive biomarkers of sensitivity to therapy. III. Identify emerging mechanism of resistance to therapy. IV. Determine changes in tumor cells induced by PARP inhibitors. OUTLINE: This is an open-label, single-arm phase II study of olaparib and durvalumab. Patients with biopsy proven TNBC will undergo a pre-treatment biopsy, after which they will receive a 28 days induction treatment of olaparib (oral, twice a day). At the 2 week mark, patients will then undergo a repeat on-treatment biopsy. Beginning cycle 2, durvalumab will be administered (intravenously [IV] over 1 hr) every 4 weeks, in addition to olaparib. Treatment repeats every 28 days for up to 13 cycles in the absence of disease progression or unacceptable toxicity. Patients deriving clinical benefit from treatment may, at the investigator's discretion and in the absence of disease progression or unacceptable toxicity, may continue on therapy beyond the planned 13 cycles. At the completion of all on-study procedures, patients will be considered off-treatment and will be followed every 6 months for disease and survival outcomes up to 1 year. Patients will be asked to submit an optional tumor biopsy in the event of disease progression.

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