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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

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

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-free Survival Per Stratum (BICR)

Progression-free Survival Per Stratum (Sensitivity Analysis)

Secondary outcome measures

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

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 / 5Eligibility criteria met

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Who is running the clinical trial?

AstraZenecaLead Sponsor

4,267 Previous Clinical Trials

288,606,708 Total Patients Enrolled

174 Trials studying Breast Cancer

1,246,339 Patients Enrolled for Breast Cancer

Andrew Tutt, MB ChB PhDPrincipal InvestigatorGuy's Hospital, Great Maze Pond, London.

Media Library

Olaparib (PARP Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03330847 — Phase 2

Breast Cancer Research Study Groups: Olaparib monotherapy, Olaparib+Ceralasertib, Olaparib+adavosertib

Breast Cancer Clinical Trial 2023: Olaparib Highlights & Side Effects. Trial Name: NCT03330847 — Phase 2

Olaparib (PARP Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03330847 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly patients being recruited for this experiment?

"This trial is open to patients that are aged 18-130, as specified in the inclusion criteria."

Answered by AI

Has Olaparib been cleared by the FDA to be used as a standalone treatment?

"While there is some data indicating that Olaparib monotherapy may be safe, it only received a score of 2 because, as a Phase 2 trial, there is no evidence demonstrating its efficacy."

Answered by AI

Is this study also taking place in other parts of the world?

"To make participating more convenient for patients, this clinical trial is running at 34 sites located around Kettering, Calgary, Charleston and other locations."

Answered by AI

What is Olaparib monotherapy's most common application?

"Olaparib monotherapy is most commonly used for the treatment of stiff shoulder, however it can also be taken to treat chilblains, catarrh and psoriasis."

Answered by AI

What is the maximum number of people who can enroll in this clinical trial?

"Unfortunately, this trial is not recruiting patients at the moment. According to the dates posted on clinicaltrials.gov, (3/7/2018-9/23/2022), it does not seem like patient recruitment is a priority for the researchers conducting this study. However, there are 2440 trials for breast cancer and 236 trials for Olaparib monotherapy that are actively searching for patients if you are interested in participating in other studies."

Answered by AI

Are we currently looking for volunteers for this experiment?

"This study is no longer active. It began on March 7th, 2018 and was last updated September 23rd, 2022. However, there are 2440 trials for breast cancer and 236 for Olaparib monotherapy that are still looking for patients."

Answered by AI

Have other researchers looked into this treatment before?

"AstraZeneca first sponsored a study on Olaparib monotherapy in 2005. This initial research project involved 98 people and, as a result of its success, Phase 1 drug approval was received. Currently, there are 236 ongoing studies involving Olaparib monotherapy taking place across 60 countries and 1509 cities."

Answered by AI

What other similar tests have been run using Olaparib monotherapy?

"The first study investigating olaparib monotherapy was completed in 2005 at a research site. As of now, there have been a total of 195 similar studies with 236 more currently underway; many of these located in Kettering, Ohio."

Answered by AI

What are the main goals of this clinical trial?

"The primary goal for this study, which will run until the date of first documented progression or censoring date or death--whichever comes first (assessed up to 32 months), is to evaluate Progression-Free Survival in order compare the efficacy of Ceralasertib+olaparib and adavosertib+olaparib combination therapy against olaparib monotherapy in BRCAm, Non BRCAm HRRm, and Non HRRm patient populations. Secondary outcomes include PFS assessment to compare the efficacy of Ceralasertib+olaparib and adavosertib"

Answered by AI

How can I sign up for this clinical trial?

"This clinical trial is enrolling 273 participants with breast cancer. All candidates should be aged 18 or 130, and must have received 1-2 lines of treatment for metastatic disease in the past (unless contraindicated). In addition, all participants must be postmenopausal or unable to bear children, have a good performance status (ECOG PS 0-1), and be male or female."

Answered by AI

Recent research and studies

The Cancer JournalJournal

DNA Damage Repair Inhibitors—combination Therapies

Smith, Gabriella, Zachary Alholm, Robert L. Coleman, and Bradley J. Monk. 2021. “DNA Damage Repair Inhibitors—combination Therapies”. The Cancer Journal. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ppo.0000000000000561.

The Cancer JournalJournal

DNA Damage Repair Inhibitors—combination Therapies

clinicaltrials.govStudy

To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.

2018. "To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03330847.

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