For Healthcare Professionals

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.

clipboard-pencil

About the study

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.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

  1. Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious.
  2. Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
  3. Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
  4. 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.
  5. 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.
  6. ECOG performance status 0-1.
  7. Adequate bone marrow, kidney and liver function.

EXCLUSION CRITERIA

  1. Prior treatment with PARP inhibitor.
  2. Patients with HER2 positive disease.
  3. More than 2 prior lines of chemotherapy for metastatic breast cancer.
  4. Untreated and/or uncontrolled brain metastases.
  5. 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.
  6. Known HIV (Human Immunodeficiency Virus) infection.
  7. Pregnant or breast-feeding women.
pin location

Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +44 (0) 1625 518869Email iconEmail Study Center

Study’s details


Contition

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

Age (in years)

18 - 99

Phase

Phase 3

Participants needed

302

Est. Completion Date

Dec 2022

Treatment type

Interventional


Sponsor

AstraZeneca

ClinicalTrials.gov identifier

NCT02000622

Study number

D0819C00003

Understanding Clinical Trials


Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
Vector

Interested?

Sign up to save your favorites, 
receive newsletters, resources, and alerts 
about clinical trials related to your conditions of interest.