Identifier
SOLTI-1911 / BIG-21-02
Sponsor
SOLTI ( GRUPO ESPAÑOL DE ESTUDIO, TRATAMIENTO Y OTRAS ESTRATEGIAS EXPERIMENTALES EN TUMORES SÓLIDOS)
Principal Investigator
MERITXELL BELLET EZQUERRA
Study details
Tumor type: BREAST
Stage: Early/Locally advanced
Main Investigational Agent : Targeted therapy
Phase: II
Randomization: Non-randomized
Molecular details
Biomarker: ER pos; HER2 neg
Biomarker criteria: Mandatory
Prescreening: Local
Additional study population requirements: ER-positive/HER2-negative according to the most recent ASCO/CAP guidelines assessed locally, tumor cells >10% ER staining, grade 2 or 3 breast cancer.
Ki-67 index by local analysis of =20% on untreated breast tissue. Note: Multifocal and multicentric tumors are permitted if they are considered clinical stage II according to Seventh Edition of the AJCC. Biopsy of all lesions is not necessary.
Drug details
Arm A: Ribociclib (neoadjuvant) + Chemotherapy (adjuvant) + Ribociclib (adjuvant)
Arm B: Ribociclib (neoadjuvant) + Ribociclib (adjuvant)
