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Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1 / 2 Mutations.

Trial Status: Closed to Accrual

This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1 / 2 mutations.

Inclusion Criteria

  • Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious.
  • Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
  • Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
  • Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting at least 12 months from last dose to study entry elapsed.
  • ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
  • ECOG performance status 0-1.
  • Adequate bone marrow, kidney and liver function.

Exclusion Criteria

  • Prior treatment with PARP inhibitor.
  • Patients with HER2 positive disease.
  • More than 2 prior lines of chemotherapy for metastatic breast cancer.
  • Untreated and/or uncontrolled brain metastases.
  • Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed.
  • Known HIV (Human Immunodeficiency Virus) infection.
  • Pregnant or breast-feeding women.

California

Sacramento
University of California Davis Comprehensive Cancer Center
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Connecticut

New Haven
Yale University
Status: CLOSED_TO_ACCRUAL

District of Columbia

Washington
MedStar Georgetown University Hospital
Status: CLOSED_TO_ACCRUAL

Florida

Jacksonville
Mayo Clinic in Florida
Status: CLOSED_TO_ACCRUAL

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: CLOSED_TO_ACCRUAL
Dana-Farber Cancer Institute
Status: CLOSED_TO_ACCRUAL
Massachusetts General Hospital Cancer Center
Status: CLOSED_TO_ACCRUAL

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE

Minnesota

Minneapolis
University of Minnesota / Masonic Cancer Center
Status: ADMINISTRATIVELY_COMPLETE
Rochester
Mayo Clinic in Rochester
Status: CLOSED_TO_ACCRUAL

New Hampshire

Lebanon
Dartmouth Hitchcock Medical Center
Status: COMPLETED

New York

New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL

North Carolina

Winston-Salem
Wake Forest University Health Sciences
Status: CLOSED_TO_ACCRUAL_AND_INTERVENTION

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: COMPLETED

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: CLOSED_TO_ACCRUAL

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: WITHDRAWN
Houston
Baylor College of Medicine / Dan L Duncan Comprehensive Cancer Center
Status: COMPLETED
San Antonio
University of Texas Health Science Center at San Antonio
Status: ADMINISTRATIVELY_COMPLETE

Trial Phase Phase III

Trial Type Treatment

Lead Organization
AstraZeneca Pharmaceuticals LP

  • Primary ID D0819C00003
  • Secondary IDs NCI-2014-01625, 2013-005137-20
  • Clinicaltrials.gov ID NCT02000622