NCT03544125

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 3 (actual)
• Sponsor: OHSU Knight Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot phase I trial studies whether it is feasible to conduct a detailed molecular profile of triple negative breast cancer as part of a treatment strategy that asks whether or not we can lower the chance of breast cancer growing or spreading, by treating with a combination of PARP inhibitor how well (olaparib) and immune therapy (durvalumab). Olaparib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as durvalumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving olaparib and durvalumab may work better in treating participants with metastatic triple negative breast cancer.

Detailed description

PRIMARY OBJECTIVE: I. To assess the feasibility of completing Clinical Laboratory Improvement Act (CLIA) analytics on pre-treatment biopsy within a planned 4-week window for enrolled participants. SECONDARY OBJECTIVES: I. Assess safety and tolerability of the proposed therapy. II. Assess response to treatment. III. Determine the time to disease progression following study therapy. IV. Determine survival of participants enrolled on the study. 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 tumor markers of emergence. IV. Determine changes in tumor cells induced by PARP inhibitors. V. Identify tumor markers suggestive of combinatorial therapy that could r overcome resistance to therapy. OUTLINE: Participants receive olaparib orally (PO) twice a day (BID) for 28 days in the absence of disease progression or unacceptable toxicity. Participants then receive olaparib PO BID on days 1-28 and durvalumab intravenously (IV) over 1 hour on day 1. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Participants may continue on therapy beyond disease progression at the discretion of the investigator. After completion of study treatment, participants are followed up every 6 months for 1 year.

Conditions

• Anatomic Stage IV Breast Cancer AJCC v8
• Estrogen Receptor Negative
• HER2/Neu Negative
• Progesterone Receptor Negative
• Prognostic Stage IV Breast Cancer AJCC v8
• Triple-Negative Breast Carcinoma

Interventions

Type	Name	Description
BIOLOGICAL	Durvalumab	Given IV
DRUG	Olaparib	Given PO

Timeline

• Start date: 2018-05-03
• Primary completion: 2018-08-07
• Completion: 2020-11-18
• First posted: 2018-06-01
• Last updated: 2020-11-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study