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. (OlympiAD)

AstraZeneca

Status and phase: Active, not recruiting; Phase 3

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

Treatments: Drug: Physician's choice chemotherapy; Drug: Olaparib

Study type: Interventional

Funder types: Industry

Identifiers

NCT02000622

2013-005137-20 (EudraCT Number)

D0819C00003

Details and patient eligibility

About

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.

Enrollment: 302 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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302 participants in 2 patient groups

Olaparib

Experimental group

Description:

Olaparib tablet 300mg bd po

Treatment:

Drug: Olaparib

Physician's choice chemotherapy

Active Comparator group

Description:

Capecitabine 2500 mg/m2 d1-14 q 21, or Vinorelbine 30 mg/m2 d1,8 q 21, or Eribulin 1.4 mg/m2 d1,8 q 21

Treatment:

Drug: Physician's choice chemotherapy