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Olaparib as Adjuvant Treatment in Patients With Germline BRCA Mutated High Risk HER2 Negative Primary Breast Cancer (OlympiA)

Clinical Trial Details

Olaparib treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.

The purpose of this study is to compare the addition of olaparib after the usual care of chemotherapy, surgery, and radiation for your type of cancer.  In this study, you will get either olaparib or placebo, a pill that looks like the study drug but contains no medication.  The use of olaparib could reduce the risk of your cancer coming back but it could also cause side effects. 

To be better than placebo, the olaparib should decrease the chance of cancer coming back as compared to the placebo.  More than 2000 patients suffering from a variety of cancers have already taken olaparib at different doses, either on its own or with another chemotherapy drug.  Olaparib is experimental and not approved by the Food and Drug Administration (FDA) for use in any type of cancer. 

As of October 2013 about 248 patients with advanced breast cancer have been treated with olaparib.  There will be about 1320 people world-wide taking part in this study.

Key eligibility:

  • Histologically confirmed non-metastatic primary invasive adenocarcinoma of the breast that is one of the following phenotypes:
    - Triple negative breast cancer defined as: ER and PgR negative AND HER2 negative (not eligible for anti-HER2 therapy)
    - ER and/or PgR positive, HER2 negative
  • Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function)
  • Completed adequate breast and axilla surgery
  • Completed at least 6 cycles neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the combination of both. Prior platinum as potentially curative treatment for prior cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer is allowed
  • ECOG 0-1
  • Detailed eligibility reviewed when you contact the study team

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Study contact by location

Upper East Side - Manhattan

Contact(s)

Marta Vallee Cobham, RN, BSN
(212) 821-0780
mac2034@med.cornell.edu

Brooklyn

Contact(s)

Tricia L. Ellis
(718) 330-7441
tre2004@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1412015745

ClinicalTrials.gov:

NCT02032823

Sponsor:

B-55

Status

Open to Enrollment

Age Group

Adult

Sponsor

Disease