A Two-stage Simon Design Phase II Study for Non-BRCA MBC Patients With HRD Treated With Olaparib Single Agent

Sponsor
MedSIR
Study ID
NCT03367689
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Olaparib — DRUG
    Olaparib 300 mg twice a day (orally) beginning on Day 1 and continuing through Day 28 of every 28-day cycle.

Study Details

This is an international, multi-centre, non-controlled, open-label, single arm, two-stage Simon Design phase II study for non-BRCA metastatic breast cancer (MBC) patients with homologous recombination deficiency treated with Olaparib single agent. The main objective is to assess the efficacy of olaparib single agent as determined by Clinical Benefit Rate (CBR) using the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). In the first stage Triple negative (TN) non-BRCA, metastatic breast cancer (MBC) patients whose tumours exhibited any characteristic related to homologous recombination deficiency (HRD). In the second stage, luminal patients (RH positive HER2 negative) will be allowed in the same conditions that TN. Patients whose tumours are identified as Homologous Recombination Deficient by deleterious HRR gene mutations (according to Foundation Medicine's Foundation One assay) will receive olaparib 300 mg (two tablets of 150mg) orally twice daily (bid) on days 1-28 each 28 days. Study commitment is 39 patients: 17 patients will be enrolled at first stage and 22 at the second stage. The total duration of the study period is 34 months.

Key Dates

Start date
Apr 17, 2018
Status verified
Jun 2022
Primary completion
Jul 31, 2021
Completion
Dec 31, 2021

Study Design

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

Arms

  • Experimental: Olaparib 300 mg
    Patients whose tumours are identified as Homologous Recombination Deficient, will receive olaparib 300 mg (two tablets of 150mg) orally twice daily (bid) on days 1-28 each 28 days.

Primary Outcome Measure

To assess the efficacy of olaparib single agent in non-BRCA MBC patients whose tumours exhibit an homologous recombination deficiency (HRD) signature, as determined by Clinical Benefit Rate (CBR) using RECIST 1.1 criteria [ Time Frame: Baseline up to 24 weeks ]

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