Cross-sectional study to assess the penetration of gBRCA1/2 genetic testing within HER2-negative recurrent high-risk early-breast cancer patients (BRCAwareness)

Cross-sectional study to assess the penetration of gBRCA1/2 genetic testing within HER2-negative recurrent high-risk early-breast cancer patients (BRCAwareness) - Cross-sectional study on BRCA testing in recurrent high-risk EBC

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000055219

Enrollment

700

Registered

2024-08-11

Start date

2024-11-02

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

Recurrent high-risk HER2-negative early-breast cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All of the following criteria must be met as primary enrollment. 1.Newly diagnosed invasive breast cancer 2.No distant metastasis from the time of diagnosis to surgery 3.18 years or older at the time of diagnosis 4.HER2 negative (Definition of HER2 negative: 0 or 1+ by immunohistochemistry (IHC), or HER2/CEP17 ratio <2.0 and HER2 copy number <6.0 by fluorescence in situ hybridization (FISH)) 5.Underwent radical surgery (mastectomy or partial mastectomy) for breast cancer between January 1, 2023 and December 31, 2023 6.Estrogen receptor (ER)-positive (ER-positive cells account for >=1% by IHC) 6-1.Four lymph node metastases (>=pN2) after prior surgery 6-2.Non-pCR (with residual invasive cancer cells) after preoperative chemotherapy 7.ER-negative (ER-positive cells account for <1% by IHC) 7-1.Invasive tumor >2 cm in diameter (>=pT2) or one lymph node metastasis (>=pN1) after prior surgery 7-2.Non-pCR (with residual invasive cancer cells) after preoperative chemotherapy To proceed to secondary enrollment, patients must have a CPS+EG score of at least 3 points if they meet the following criteria 6.ER-positive and 2.non-pCR after preoperative chemotherapy

Exclusion criteria

Exclusion criteria: Cases deemed ineligible by the attending physician

Design outcomes

Primary

Measure	Time frame
Proportion of gBRCA1/2 genetic testing performed	—

Secondary

Measure	Time frame
Factors associated with not taking gBRCA1/2 genetic testing Proportion of patients with gBRCA1/2 pathogenic variants among those who underwent gBRCA1/2 genetic testing Proportion of patients initiated on olaparib among gBRCA1/2 pathogenic variant holders Drug therapy used other than olaparib in gBRCA1/2 pathogenic variant carriers	—

Countries

Japan

Contacts

Public ContactTomoe Taji

Kansai Medical University Hospital Department of Breast Surgery

taji.tom@kmu.ac.jp0728042720

Outcome results