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NCT03286842 · ClinicalTrials.gov registry record · Phase 3

To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients.

A Phase 3 study of HER2-ve Metastatic Breast Cancer and Germline BRCA1/2 Mutations, sponsored by AstraZeneca.

Completed
Registry status
Phase 3
Development phase
256
Enrollment target
20
Study locations

NCT03286842: Completed Phase 3 study of HER2-ve Metastatic Breast Cancer and Germline BRCA1/2 Mutations, sponsored by AstraZeneca.

NCT03286842 is a Phase 3 study of HER2-ve Metastatic Breast Cancer and Germline BRCA1/2 Mutations that has completed, run by AstraZeneca. The registered enrollment target is 256 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03286842, a Phase 3 study of HER2-ve Metastatic Breast Cancer and Germline BRCA1/2 Mutations, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
Phase 3
Development phase
256 participants
Enrollment target
20
Study locations

Study Summary

This open-label, multi-centre phase IIIb study will assess the effectiveness, benefits and potential harms in the use of olaparib monotherapy treatment for patients with HER2-ve metastatic breast cancer associated with germline or somatic breast cancer susceptibility gene (gBRCA1/2 or sBRCA1/2) mutations.

Primary Outcome

The clinical effectiveness of olaparib treatment in HER2-ve metastatic breast cancer participants in a real-world setting through assessment of PFS in germline BRCA mutated patients was evaluated. PFS is defined as the time from first dose of olaparib to the date of progression or death from any cause. In this study, disease progression in gBRCAm patients will be based on Investigator assessment, i.e. radiological ( e.g. RECIST) progression, symptomatic progression, or clear progression of non-m

Conditions Studied

HER2-ve Metastatic Breast Cancer Germline BRCA1/2 Mutations Somatic BRCA1/2 Mutations

Interventions

  • DRUG Olaparib

Study Locations (20)

Other

  • Research Site - Plovdiv
  • Research Site - Sofia
  • Research Site - Sofia
  • Research Site - Varna
  • Research Site - Angers
  • Research Site - Avignon
  • Research Site - Besançon
  • Research Site - Bordeaux
  • Research Site - Caen
  • Research Site - Le Mans
  • Research Site - Lille
  • Research Site - Limoges
  • Research Site - Lorient
  • Research Site - Marseille
  • Research Site - Montpellier

Maryland

  • Research Site - Towson

Mississippi

  • Research Site - Jackson

British Columbia

  • Research Site - Vancouver

Ontario

  • Research Site - Toronto

Quebec

  • Research Site - Québec

Trial Details

FieldValue
Enrollment Target 256 participants
Start Date 2018-01-17
Est. Completion 2021-10-08
Phase Phase 3
AstraZeneca

1,285 total trials

What the finished NCT03286842 record still lists

NCT03286842 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (67% lower).

The record links to 3 conditions, with HER2-ve Metastatic Breast Cancer appearing as the primary indexed condition, and to 1 intervention - of which Olaparib is the first listed.

NCT03286842 names 20 study sites across 6 states, led by Other, Maryland, Mississippi.

Frequently Asked Questions

What is clinical trial NCT03286842 about?

NCT03286842 is a clinical study titled "To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients.". This open-label, multi-centre phase IIIb study will assess the effectiveness, benefits and potential harms in the use of olaparib monotherapy treatment for patients with HER2-ve metastatic breast cancer associated with germline or somatic breast cancer susceptibility gene (gBRCA1/2 or sBRCA1/2) muta...

What is the current status of trial NCT03286842?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 256 participants. The study started on 2018-01-17. Estimated completion is 2021-10-08.

What conditions does trial NCT03286842 study?

This clinical trial studies the following conditions: HER2-ve Metastatic Breast Cancer, Germline BRCA1/2 Mutations, Somatic BRCA1/2 Mutations.

What interventions are being tested in trial NCT03286842?

The interventions under investigation include: Olaparib (DRUG).

Who is sponsoring clinical trial NCT03286842?

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

Where is trial NCT03286842 being conducted?

This trial has 20 study locations across Maryland, Mississippi, British Columbia, Ontario, Quebec. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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How this trial's enrollment target compares

Where NCT03286842's enrollment target sits among peer trials

256 1240th of 2000 higher than 759 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03286842, the US trial registry maintained by the National Library of Medicine. NCT03286842 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.