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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.

NCT02000622

CompletedPhase 3

Sponsor: AstraZeneca

Conditions: Breast Cancer Metastatic, BRCA 1 Gene Mutation, BRCA 2 Gene Mutation

Interventions: Olaparib, Physician's choice chemotherapy

Countries: United States, Bulgaria, China, Czechia, France, Hungary, Italy, Japan

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.

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.

Locations (171)

San Diego, California, United States
Santa Rosa, California, United States
Whittier, California, United States
Denver, Colorado, United States
New Haven, Connecticut, United States
Washington D.C., District of Columbia, United States
Jacksonville, Florida, United States
Orlando, Florida, United States
Plantation, Florida, United States
Columbus, Georgia, United States
Marietta, Georgia, United States
Chicago, Illinois, United States
Niles, Illinois, United States
Wichita, Kansas, United States
Lafayette, Louisiana, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Detroit, Michigan, United States
Grand Rapids, Michigan, United States
Rochester, Minnesota, United States
Saint Louis Park, Minnesota, United States
Jackson, Mississippi, United States
Columbia, Missouri, United States
St Louis, Missouri, United States
Lebanon, New Hampshire, United States
Commack, New York, United States
Harrison, New York, United States
New York, New York, United States
New York, New York, United States
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