NCT03078036 (BREAKOUT) is a clinical trial of Germline BRCA Test (blood) in Breast Cancer, sponsored by AstraZeneca.

Who is sponsoring NCT03078036?

NCT03078036 is sponsored by AstraZeneca.

What drugs are being tested in NCT03078036?

Interventions in NCT03078036: Germline BRCA Test (blood), FoundationOne Dx Genomic Profile (archival Tumour Specimen), Follow-up.

What condition does NCT03078036 study?

NCT03078036 studies Breast Cancer.

Is NCT03078036 still recruiting?

NCT03078036 is currently completed. Last updated 20 May 2020.

Last reviewed 2020-05-20 · How we verify

NCT03078036: BREAKOUT

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Last updated 20 May 2020

What this trial tests

trial testing Germline BRCA Test (blood) in Breast Cancer in 873 participants. Completed in 20 May 2019.

Timeline

13 March 2017

Primary endpoint
20 May 2019

20 May 2019

Quick facts

Lead sponsor	AstraZeneca
Status	Completed
Study type	OBSERVATIONAL
Enrollment	873
Start date	13 March 2017
Primary completion	20 May 2019
Estimated completion	20 May 2019
Sites	98 locations across Italy, Japan, Russia, Taiwan, United Kingdom, Germany, Hungary, Poland

Drugs / interventions tested

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

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

AstraZeneca — full company profile →

Who can join

18 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

Biomarkers in Triple-Negative Breast Cancer: State-of-the-Art and Future Perspectives.
Cocco S, Piezzo M, Calabrese A, Cianniello D, et al · · 2020 · cited 91× · PMID 32605126 · DOI 10.3390/ijms21134579
Prevalence of germline BRCA mutations in HER2-negative metastatic breast cancer: global results from the real-world, observational BREAKOUT study.
O'Shaughnessy J, Brezden-Masley C, Cazzaniga M, Dalvi T, et al · · 2020 · cited 40× · PMID 33109210 · DOI 10.1186/s13058-020-01349-9
Prevalence of mutations in BRCA and homologous recombination repair genes and real-world standard of care of Asian patients with HER2-negative metastatic breast cancer starting first-line systemic cytotoxic chemotherapy: subgroup analysis of the global BREAKOUT study.
Koh SJ, Ohsumi S, Takahashi M, Fukuma E, et al · · 2022 · cited 7× · PMID 34467476 · DOI 10.1007/s12282-021-01283-4

Verify or expand the search:

Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

NCT06148038 — CBD for Breast Cancer Primary Tumors · Phase 1 · recruiting
NCT07405801 — A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus R · Phase 2 · recruiting
NCT07285993 — Detection and Outcomes in Metastatic Invasive Lobular Breast Cancer Through Novel F-18 FAP PET · Phase 2 · recruiting
NCT07510698 — Same-Day Awake Mastectomy With Immediate Breast Reconstruction for Patients With Breast Cancer · NA · recruiting
NCT06768931 — Biolosion Combined Standard Neoadjuvant Therapy to Treat Triple-negative Breast Cancer · Phase 2 · recruiting

Other AstraZeneca trials

Trials by the same sponsor.

NCT06998095 — Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea · not yet recruiting
NCT07431775 — Saphnelo Use in Females of Child-bearing Potential · not yet recruiting
NCT07516184 — Explore the Diagnostic Value of Bronchodilation Test With Portable Oscillometry in Asthma Diagnosis · NA · not yet recruiting
NCT07279935 — Osimertinib Combined With Chemotherapy in Patients Who Had Distant Recurrence After Adjuvant Osimertinib for EGFRm Resec · Phase 4 · not yet recruiting
NCT07279948 — A Single-arm Observational Study to Characterize the Demographic, Clinical Features and Outcomes of a Brazilian Cohort o · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03078036 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 20 May 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03078036.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing