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ABCSG 63 / ERIKA: Elacestrant and RIbociclib in Ki67-tested endocrine responsive breAst cancer: An open-label, two-arm, randomized, phase II study of elacestrant plus ribociclib vs. AI (plus GnRH agonist in pre-/perimenopausal women and men) plus ribociclib as neoadjuvant therapy for endocrine-responsive HER2-negative early breast cancer

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-505758-17-00
Acronym
ABCSG 63
Enrollment
120
Registered
2025-04-24
Start date
2025-08-21
Completion date
Unknown
Last updated
2025-12-10

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

Conditions

endocrine-responsive HER2-negative early breast cancer

Brief summary

Proportion of modified PEPI score of 0 at the time of surgery

Detailed description

Proportion of endocrine-responsive tumors (i.e., Ki-67 10 %) determined by local pathology via C1D22 biopsy, Locally and centrally measured Ki-67 (via C1D22 visit biopsy), Proportion of RCB 0/I at the time of surgery determined by local pathology, Proportion of pCR at the time of surgery, Change of radiological tumor size from screening to 3 months of treatment and to pre-surgery

Interventions

DRUGEXEMESTANE
DRUG-
DRUGANASTROZOLE
DRUGORSERDU 345 mg film-coated tablets
DRUGKisqali 200 mg film-coated tablets
DRUGORSERDU 86 mg film-coated tablets
DRUGLETROZOLE

Sponsors

Verein Zur Praevention Und Therapie Boesartiger Erkrankungen Austrian Breast And Colorectal Cancer Study Group
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Proportion of modified PEPI score of 0 at the time of surgery—

Secondary

MeasureTime frame
Proportion of endocrine-responsive tumors (i.e., Ki-67 10 %) determined by local pathology via C1D22 biopsy, Locally and centrally measured Ki-67 (via C1D22 visit biopsy), Proportion of RCB 0/I at the time of surgery determined by local pathology, Proportion of pCR at the time of surgery, Change of radiological tumor size from screening to 3 months of treatment and to pre-surgery—

Countries

Austria, Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026