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NCT03330847 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Metastatic Triple-Negative Breast Cancer, sponsored by AstraZeneca.

Active
Registry status
Phase 2
Development phase
273
Enrollment target
20
Study locations

NCT03330847 is a Phase 2 study of Metastatic Triple-Negative Breast Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 273 participants, above the 37-participant average among 5 other Metastatic Triple-Negative Breast Cancer trials with a reported enrollment target (638% higher). The trial reports 20 study locations across 15 states.

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The verdict

NCT03330847, a Phase 2 study of Metastatic Triple-Negative Breast Cancer, is active but no longer recruiting, sponsored by AstraZeneca.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
273 participants
Enrollment target
20
Study locations

Study Summary

This study is to assess the efficacy and safety of olaparib monotherapy versus olaparib in combination with an inhibitor of ATR (Ataxia-Telangiectasia Mutated (ATM) and Rad3-related protein kinase (Ceralasertib \[AZD6738\]) and olaparib monotherapy versus olaparib in combination with an inhibitor of WEE1 (adavosertib \[AZD1775\]) in second or third line setting in patients with Triple-negative breast cancer (TNBC) prospectively stratified by presence/absence of qualifying tumour mutation in genes involved in the homologous recombination repair (HRR) pathway. Treatment arms are olaparib monotherapy, olaparib+ Ceralasertib and olaparib+adavosertib. The study subject population will be divided into Stratum A, Stratum B, and Stratum C. Due to the different schedules of administration of each of the treatment options as well as their different toxicity profiles, the study is not blinded. Study has two stage consent process- stage 1 consent (molecular screening for HRR defects) and stage 2 consent (main study). Patients with TNBC and with known qualifying BRCAm, non BRCAm HRRm and non HRRm status will be offered the option of consenting to the main part of the study within the 28-day screening period. Following the ISRC meeting on 17 April 2019 a recommendation was made to close the adavosertib+olaparib treatment arm across all biomarker strata. Patients receiving treatment with adavosertib+olaparib treatment were offered the opportunity to continue treatment on olaparib monotherapy at the approved dose (300 mg bd). Following the closure of this arm the total number of patients randomised will be lower (approximately 350 patients). Approximately 300 patients will be randomised (using randomisation ratio 1:1) to 2 ongoing treatment arms plus an additional 47 patients to a 3rd arm (olaparib+adavosertib) prior to the arm being discontinued.

Conditions Studied

Metastatic Triple-Negative Breast Cancer

Interventions

  • DRUG Olaparib Continuous (28-Day cycle) 300 mg BD.
  • DRUG Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle).
  • DRUG Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle).

Study Locations (20)

New York

  • Research Site - East Setauket
  • Research Site - Lake Success
  • Research Site - Mineola
  • Research Site - Mount Kisco
  • Research Site - Stony Brook

Kentucky

  • Research Site - Hazard
  • Research Site - Louisville

Alabama

  • Research Site - Birmingham

Alaska

  • Research Site - Anchorage

Arizona

  • Research Site - Gilbert

Colorado

  • Research Site - Aurora

Connecticut

  • Research Site - New Haven

Illinois

  • Research Site - Chicago

Trial Details

FieldValue
Enrollment Target 273 participants
Start Date 2018-03-07
Est. Completion 2026-09-04
Phase Phase 2

Sponsor

AstraZeneca

1,285 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03330847

The ClinicalTrials.gov registry entry for NCT03330847 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 273 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 37-participant average among 5 other Metastatic Triple-Negative Breast Cancer trials with a reported enrollment target (638% higher). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Metastatic Triple-Negative Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Olaparib Continuous (28-Day cycle) 300 mg BD. is the first listed.

NCT03330847 reports 20 study locations spanning 15 distinct geographic areas - top geographies include New York, Kentucky, Alabama.

Frequently Asked Questions

What is clinical trial NCT03330847 about?

NCT03330847 is a clinical study titled "To Assess Safety and Efficacy of Agents Targeting DNA Damage Repair With Olaparib Versus Olaparib Monotherapy.". This study is to assess the efficacy and safety of olaparib monotherapy versus olaparib in combination with an inhibitor of ATR (Ataxia-Telangiectasia Mutated (ATM) and Rad3-related protein kinase (Ceralasertib \[AZD6738\]) and olaparib monotherapy versus olaparib in combination with an inhibitor of...

What is the current status of trial NCT03330847?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 273 participants. The study started on 2018-03-07. Estimated completion is 2026-09-04.

What conditions does trial NCT03330847 study?

This clinical trial studies the following conditions: Metastatic Triple-Negative Breast Cancer.

What interventions are being tested in trial NCT03330847?

The interventions under investigation include: Olaparib Continuous (28-Day cycle) 300 mg BD. (DRUG), Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle). (DRUG), Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle). (DRUG).

Who is sponsoring clinical trial NCT03330847?

This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03330847 being conducted?

This trial has 20 study locations across Alabama, Alaska, Arizona, Colorado, Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.