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PARP Inhibitor

Olaparib Monotherapy vs Combination Therapy for Breast Cancer

Phase 2

Waitlist Available

Led By Andrew Tutt, MB ChB PhD

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Histologically or cytologically confirmed TNBC at initial diagnosis with evidence of metastatic disease and HER2 negative as per ASCO-CAP HER2 guideline recommendations 2013

Patients must have received at least 1 and no more than 2 prior lines of treatment for metastatic disease with an anthracycline (eg, doxorubicin, epirubicin) and/or a taxane (eg, paclitaxel, docetaxel) unless contraindicated, in either the neo-adjuvant, adjuvant or metastatic setting

Must not have

Patients with known active hepatitis (ie, hepatitis B or C)

More than 2 prior lines of cytotoxic chemotherapy for metastatic disease (prior treatments with hormonal, non-hormonal, biologics or the combination of an aromatase inhibitor and everolimus are not counted as a prior line of therapy)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the date of randomisation until time of data cut-off date or death due to any cause (assessed up to 32 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing two different treatments for triple negative breast cancer patients who have not responded to earlier treatments. One treatment is olaparib monotherapy and the other is olaparib in combination with an inhibitor of ATR. The study will enroll approximately 300 patients who will be randomly assigned to one of the two treatment arms.

Who is the study for?

This trial is for adults with Triple-negative breast cancer (TNBC) who have measurable metastatic disease, are postmenopausal or using contraception, and have received no more than two prior chemotherapy treatments. They must not be immunocompromised, have had previous PARP inhibitor treatment, uncontrolled medical issues, brain metastases that cause symptoms, or gastrointestinal disorders affecting medication absorption.

What is being tested?

The study compares the effectiveness of Olaparib alone versus in combination with Ceralasertib or Adavosertib in patients with TNBC stratified by tumor mutations related to DNA repair. It's an open-label trial where participants know which treatment they're getting; one arm was closed based on recommendations.

What are the potential side effects?

Potential side effects include nausea, fatigue, low blood counts leading to increased infection risk or bleeding problems, allergic reactions to medications involved in the trials (Olaparib and its combinations), as well as possible liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My breast cancer is triple-negative and has spread, with tests confirming it's not HER2 positive.

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I've had 1-2 treatments with specific drugs for my advanced cancer.

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My tumor has a specific HRR mutation or none, confirmed by a test.

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My cancer is getting worse.

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My organ and bone marrow functions are normal as tested within the last 28 days.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active hepatitis B or C.

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I've had over 2 chemotherapy treatments for my cancer that has spread.

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I have recovered from major surgery that occurred more than 2 weeks ago.

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I have brain metastases that are causing symptoms and are not under control.

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I cannot swallow pills or have a stomach condition that affects medication absorption.

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My heart's electrical activity (QTc interval) is longer than normal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the date of randomisation until time of data cut-off date or death due to any cause (assessed up to 32 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the date of randomisation until time of data cut-off date or death due to any cause (assessed up to 32 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the date of randomisation until time of data cut-off date or death due to any cause (assessed up to 32 months) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free Survival Per Stratum (BICR)

Progression-free Survival Per Stratum (Sensitivity Analysis)

Secondary study objectives

Duration of Response (DoR) [Per BICR and Per Sensitivity Analysis]

Number of Patients With Objective Response (Per BICR and Per Sensitivity Analysis)

Number of Patients With Treatment Emergent Adverse Events (TEAEs)

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Active Control

Group I: Olaparib monotherapyActive Control1 Intervention

All randomized patients will receive Olaparib monotherapy 300 mg twice daily (BD).

Group II: Olaparib+CeralasertibActive Control1 Intervention

All randomized patients will receive Olaparib 300 mg twice daily+Ceralasertib 160 mg once daily (OD).

Group III: Olaparib+adavosertibActive Control1 Intervention

All randomized patients will receive Olaparib 200 mg BD +adavosertib 150 mg BD. Following the discontinuation of adavosertib+olaparib treatment arm on 18 April 2019, patients receiving treatment with adavosertib+olaparib treatment were offered the opportunity to continue treatment on olaparib monotherapy at the approved dose (300 mg bd).

0 / 11Eligibility criteria met