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

First listed
Apr 30, 2019
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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