Olaparib+Trastuzumab in HER2[+],Breast Cancer Susceptibility Gene (BRCA) Mutated Advanced Breast Cancer

Sponsor
MedSIR
Study ID
NCT03931551
Phase
PHASE2
Status
Terminated

Conditions

  • Advanced Breast Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olaparib [Lynparza®] plus Trastuzumab [Herceptin®] — DRUG
    Participants will receive olaparib (300 mg tablets, orally twice daily during 21-day cycles) in combination with herceptin (intravenous dose of 4 mg/kg body weight with subsequent weekly doses of 2 mg/kg or subcutaneous dose of 600 mg every 3 weeks) until progression or unacceptable toxicity.

Study Details

This is a multicenter, open-label, single-arm, phase II clinical trial, phase II trial will evaluate the efficacy and safety of olaparib plus trastuzumab in patients with HER2\[+\], BRCA-mutated advanced breast cancer

Key Dates

Start date
Apr 30, 2019
Status verified
Jun 2022
Primary completion
Mar 2, 2022
Completion
Mar 2, 2022

Study Design

Enrollment
5 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Interventional Arm
    Olaparib tablet 300mg bd po + Herceptin (IV 4 mg/kg body followed by weekly doses of 2 mg/kg, or SC 600 mg every 3 weeks) until progression or unacceptable toxicity.

Primary Outcome Measure

Assess the efficacy of olaparib in combination with trastuzumab [ Time Frame: Baseline up to 12 months. ]

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