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To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients.

NCT03286842 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2023-01-17

Study results available
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Summary

This open-label, multi-centre phase IIIb study will assess the effectiveness, benefits and potential harms in the use of olaparib monotherapy treatment for patients with HER2-ve metastatic breast cancer associated with germline or somatic breast cancer susceptibility gene (gBRCA1/2 or sBRCA1/2) mutations.

Conditions

  • HER2-ve Metastatic Breast Cancer
  • Germline BRCA1/2 Mutations
  • Somatic BRCA1/2 Mutations

Interventions

DRUG

Olaparib

Patients will be administered olaparib orally, twice daily at 300 mg. Two (2) 150 mg olaparib tablets should be taken at the same time each morning and evening of every day, approximately 12 hours apart.

Sponsors & Collaborators

Principal Investigators

  • Karen Gelmon, MD, FRCPC · BritishColumbiaCancerAgency, 600W.10th Ave,Vancouver,Canada.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
130 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-17
Primary Completion
2021-10-08
Completion
2021-10-08
FDA Drug
Yes

Countries

  • United States
  • Bulgaria
  • Canada
  • France
  • Germany
  • Hungary
  • Italy
  • Japan
  • Poland
  • Russia
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03286842 on ClinicalTrials.gov