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  /    /  LACOG 0115 – LORELEI

A Phase II Randomized, Double-Blind, Parallel Cohort Study of Neoadjuvant Letrozole + GDC-0032 versus Letrozole + Placebo in Post-Menopausal Women with ER+/HER2- Primary Breast Cancer

Type of Study: Clinical Trial

Sponsor / Support: LACOG, BIG, ABCSG, Genentech

Primary Objectives: To evaluate the efficacy of combining GDC-0032 with letrozole in women with ER+/HER2- early breast cancer, in terms of the co-primary endpoints of Tumor overall response rate (ORR), assessed by RECIST criteria by breast MRI; Pathological complete response in breast and axilla (total pCR).

Design: Parallel, 2-arm, randomized, double-blind, multicenter, pre-operative study to evaluate the effect of combining GDC-0032 to standard neoadjuvant aromatase inhibitor therapy with letrozole in postmenopausal women with ER+/HER2- untreated, stage I-III operable breast cancer.

Sample Size: 331 patients.

Principal Investigator: Gustavo Werutsky

Countries LATAM: Brazil