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DORA - Triple Negative Breast Cancer - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn how well a study drug, called olaparib, works in triple negative breast cancer that has responded to platinum chemotherapy (cisplatin or carboplatin) when it is given alone or when it is combined with durvalumab (another investigational drug).

Triple negative breast cancer means that the cancer cells tested negative for estrogen receptors (ER-), progesterone receptors (PR-), and human epidermal growth factor receptor 2 (HER2).

We hope the information learned from this study will help doctors understand more about olaparib and durvalumab as potential drugs for breast cancer therapy.

What is the Condition Being Studied?

Breast Cancer - Metastatic Triple Negative

Who Can Participate in the Study?

Women age 21 or older who:
- Have breast cancer that is metastatic (has spread) and is triple negative (does not have high levels of HER2 or HR proteins)
- Are currently receiving treatment with cisplatin or carboplatin

Age Group
Adults

What is Involved?

If you choose to join this study, you will:
- Be randomly assigned (like the flip of a coin) to one of two treatment groups:
--- Olaparib alone or
--- Olaparib in combination with durvalumab
- Get every 28 days

- Come to the Duke Cancer Center clinic every 4 weeks for a physical exam, blood test, to see how you are doing and to get the next dose of study drug(s).

Each clinic visit will last 1-8 hours.

You can stay in the study for as long as the study drugs appear to the study doctor to be working for you.

Study Details

Full Title
Phase II Multicenter Study of Durvalumab (MEDI4736) and Olaparib in Platinum-Treated Advanced Triple Negative Breast Cancer - DORA - ESR-15-11311/EPM 6724
Principal Investigator
Medical Oncologist
Protocol Number
IRB:PRO00100294
NCT:NCT03167619
Phase
Phase II
ClinicalTrials.gov
Contact the Duke Recruitment Innovation Center
studyrecruitment@duke.edu
or
919-681-5698