Active — Not RecruitingNot Applicable

A Non-interventional Prospective Study of Early HER2-negative High-risk Breast Cancer and BRCA1/2 Mutations Prevalence in RussiA

Russia625 participantsStarted 2023-06-30

Plain-language summary

(Neo)adjuvant treatment approaches and outcomes

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Signed ICF, including patient's consent for genetic testing specimens from primary tumor and blood samples
✓. High risk of recurrence according to one or more criteria:
✓. incomplete pathomorphological response (in case of neoadjuvant therapy)
✓. CPS-EG 3 scale score 3 and more (in case of neoadjuvant therapy)
✓. presence of ≥ 4 metastatic lymph nodes in HR+ pts (in case of only adjuvant therapy)
✓. ≥pT2 or ≥pN1 in TNBC pts (in case of only adjuvant therapy)
✓. Any other high risk criterion according to investigators opinion

What they're measuring

The primary objective of this study is to determine the prevalence of germline and somatic BRCA1/2 mutations in high-risk early HER2-negative breast cancer

Timeframe: 3 years

Trial details

NCT IDNCT05939128

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2027-09-30

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