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

NCT03544125 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-11-20

No results posted yet for this study

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.

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

BIOLOGICAL

Durvalumab

Given IV

DRUG

Olaparib

Given PO

Sponsors & Collaborators

  • Oregon Health and Science University

    collaborator OTHER

  • Prospect Creek Foundation

    collaborator UNKNOWN

  • OHSU Knight Cancer Institute

    lead OTHER

Principal Investigators

  • Zahi Mitri, MD, MS · OHSU Knight Cancer Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-03
Primary Completion
2018-08-07
Completion
2020-11-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03544125 on ClinicalTrials.gov