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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000029029

Enrollment

Registered

2017-09-06

Start date

2016-11-25

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Provision of signed, written and dated informed consent. 2. Adult females (according to the age of majority/adulthood as defined by local regulations). 3. Histologically or cytologically confirmed HER2-ve breast cancer with evidence of metastatic disease. 4. Initiated treatment with 1st line systemic cytotoxic chemotherapy (not hormonal therapy) for metastatic breast cancer in the last 90 days and, at that time, are considered to have exhausted hormone therapy options (if HR+ve).

Exclusion criteria

Exclusion criteria: 1. Previous enrolment in this study. 2. Involvement in the planning and/or conduct of this study (applies to both AstraZeneca staff and/or staff at the study site). 3. Current participation in a clinical study with an investigational oncology product. 4. Previous PARPi therapy, including, but not limited to, participation in a previous clinical study that included PARPi therapy. 5. Current commencement of PARPi treatment.

Design outcomes

Primary

Measure	Time frame
the prevalence of gBRCA gene mutations	—

Countries

Japan,Asia(except Japan),North America,Europe

Contacts

Public ContactAstraZeneca K.K.

Medical Medical Evidence & Observational Research

Tatsunori.Jinnai@astrazeneca.com06-7711-3714

Outcome results