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AN OPEN-LABEL, RANDOMISED PHASE 1B/2 STUDY OF PF-04691502 IN COMBINATION WITH LETROZOLE COMPARED WITH LETROZOLE ALONE IN PATIENTS WITH ESTROGEN RECEPTOR POSITIVE, HER-2 NEGATIVE EARLY BREAST CANCER

Update Il y a 4 ans
Reference: EUCTR2011-003044-53

Woman Man

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Extract

Phase 1B: To assess the tolerability of PF-04691502 combined with letrozole in postmenopausal patients with ER positive, HER 2 negative advanced breast cancer. Phase 2: To compare the change in Ki-67 value from baseline to Week 6 in matched tumor biopsies from patients with ER positive, HER-2 negative early breast cancer treated with PF-04691502 in combination with letrozole or letrozole alone.

Inclusion criteria

  • ESTROGEN RECEPTOR POSITIVE, HER-2 NEGATIVE EARLY BREAST CANCER WITH KI-67 HIGHER THAN 10% AND ESTROGEN RECEPTOR POSITIVE, HER-2 NEGATIVE ADVANCED BREAST CANCER

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