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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

18 Years - 130 Years

Healthy Volunteers

Not accepted

Interventions

• Olaparib — DRUG
  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.

Study Details

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.

Key Dates

Start date

Jan 17, 2018

Status verified

Nov 2022

Primary completion

Oct 8, 2021

Completion

Oct 8, 2021

Study Design

Enrollment

256 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Olaparib
  Olaparib 150mg tablets administered orally twice daily continuously

Primary Outcome Measure

Progression-free Survival (PFS) in Real-world Setting in Germline BRCA Mutated Participants [ Time Frame: At every visit until the earliest of disease progression, death or end of study (up to 3 years) ]

Locations (2)

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