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NCT03078036 · ClinicalTrials.gov registry record

International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study

A clinical trial of Breast Cancer, sponsored by AstraZeneca.

Completed
Registry status
873
Enrollment target
20
Study locations

NCT03078036 is a study of Breast Cancer that has completed, run by AstraZeneca. The registered enrollment target is 873 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (69% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT03078036, a study of Breast Cancer, has completed, sponsored by AstraZeneca.

COMPLETED
Registry status
873 participants
Enrollment target
20
Study locations

Study Summary

BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study BREAKOUT is a prospective cross-sectional cohort study of human epidermal growth factor receptor 2 negative metastatic breast cancer patients who have started 1st line systemic cytotoxic chemotherapy. The study will estimate the prevalence of germline breast cancer susceptibility gene in an otherwise unselected population, describe the treatments administered and estimate the associated clinical outcomes of overall survival and progression-free survival amongst mutation carriers within the context of a low poly ADP ribose polymerase inhibitor treatment setting. Other exploratory analyses may be undertaken to describe somatic breast cancer susceptibility gene and other homologous recombination repair gene mutations.

Conditions Studied

Breast Cancer

Interventions

  • GENETIC Germline BRCA Test (blood)
  • GENETIC FoundationOne Dx Genomic Profile (archival Tumour Specimen)
  • OTHER Follow-up

Study Locations (20)

Texas

  • Research Site - Dallas
  • Research Site - Denton
  • Research Site - Flower Mound
  • Research Site - Houston
  • Research Site - Houston
  • Research Site - Paris
  • Research Site - San Antonio
  • Research Site - The Woodlands

Other

  • Research Site - Dobrich
  • Research Site - Rousse
  • Research Site - Sofia

Washington

  • Research Site - Vancouver
  • Research Site - Wenatchee

California

  • Research Site - Santa Barbara

Colorado

  • Research Site - Denver

Florida

  • Research Site - Hialeah

Virginia

  • Research Site - Newport News

Queensland

  • Research Site - Redcliffe

Trial Details

FieldValue
Enrollment Target 873 participants
Start Date 2017-03-13
Est. Completion 2019-05-20

Sponsor

AstraZeneca

1,285 total trials

Interested in This Trial?

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03078036

The ClinicalTrials.gov registry entry for NCT03078036 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 873 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (69% lower). The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Germline BRCA Test (blood) is the first listed.

NCT03078036 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Texas, Other, Washington.

Frequently Asked Questions

What is clinical trial NCT03078036 about?

NCT03078036 is a clinical study titled "International Breast Cancer Biomarker,Standard of Care and Real World Outcomes Study". BREAKOUT -International Breast Cancer Biomarker, Standard of Care and Real World Outcomes Study BREAKOUT is a prospective cross-sectional cohort study of human epidermal growth factor receptor 2 negative metastatic breast cancer patients who have started 1st line systemic cytotoxic chemotherapy. The...

What is the current status of trial NCT03078036?

This trial is currently completed. The enrollment target is 873 participants. The study started on 2017-03-13. Estimated completion is 2019-05-20.

What conditions does trial NCT03078036 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT03078036?

The interventions under investigation include: Germline BRCA Test (blood) (GENETIC), FoundationOne Dx Genomic Profile (archival Tumour Specimen) (GENETIC), Follow-up (OTHER).

Who is sponsoring clinical trial NCT03078036?

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

Where is trial NCT03078036 being conducted?

This trial has 20 study locations across California, Colorado, Florida, Texas, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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.