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
LACOG 0217 – IRONMAN
LACOG 0218 – Hercules
LACOG 0415 – APA in Prostate Cancer
LACOG 0515 – Testicular Registry
LACOG 0519 – PEACE III
LACOG 0620 – ExBAT
LACOG 1120 – RENAL REGISTRY
LACOG 1518 – Bladder Cancer Registry
LACOG 1818 – Prostate Cancer Registry