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

Part of paid clinical trials in Portland, Oregon.

Sponsor
OHSU Knight Cancer Institute
Study ID
NCT03544125
Phase
PHASE1
Status
Completed

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 3, 2018
Status verified
Nov 2020
Primary completion
Aug 7, 2018
Completion
Nov 18, 2020

Study Design

Enrollment
3 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (olaparib, durvalumab)
    Participants receive olaparib 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 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.

Primary Outcome Measure

Proportion of completion of Clinical Laboratory Improvement Act (CLIA) analytics on pre-treatment biopsy before the planned for 4-week biopsy [ Time Frame: At day 28 ]

Locations (1)

FacilityCityStateZIPSite coordinators
OHSU Knight Cancer InstitutePortlandOregon97239-

Find similar trials in Portland, OR

By research site
OHSU Knight Cancer Institute· Portland, OR

Related Studies