Last updated on May 2018

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


Brief description of study

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.

Detailed Study Description

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).

Triple negative non-BRCA metastatic breast cancer women (for the first stage) age 18 years that had previously received at least one (and no more than three) line for their metastatic disease. Patients must have previously received taxanes either in the early or in the metastatic scenario. To be included in the trial, tumours must be considered homologous recombination deficient (HRD) according to Foundation Medicine's Foundation One assay. Evidence of measurable metastatic disease is required.

In the second stage, luminal patients (RH positive HER2 negative) will be allowed to participate in the same conditions that TN patients.

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.

During the period between the end of the first stage and the beginning of the second, an interim analysis will be conducted to assess the viability of the second part of the trial.

The total duration of the study period is 34 months.

Stage I:

  • Recruitment period: 10 months
  • Follow-up period: Up to 6 months after last patient included in the study

Stage II:

  • Recruitment period: 12 months
  • Follow-up period: up to 6 months after last patient included in the study

Clinical Study Identifier: NCT03367689

Contact Investigators or Research Sites near you

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Kepa Amillano

Hospital Sant Joan
Reus, Spain
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Recruitment Status: Open


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