Trial intelligence / Profile preview

NEO-ORB: Alpelisib or Buparlisib + Letrozole in Neoadjuvant Breast Cancer

NCT01923168Phase 2Completed

Sponsor
Novartis
Start
Mar 2014
Primary completion
Jul 2017
Modality
Small Molecules
Countries
17
01

Overview

Phase 2, randomised, double-blind trial of alpelisib in Breast cancer (hormone receptor-positive/human epidermal growth factor receptor 2-negative) (3 arms), sponsored by Novartis. Primary endpoints: Pathological Complete Response (pCR) in PIK3CA Mutant Cohort at 24 weeks, Pathological Complete Response (pCR) in PIK3CA Wild-type Cohort at 24 weeks and 2 more. Started Mar 2014; status: completed.

02

Drugs

alpelisib
03

Conditions

Breast cancer (hormone receptor-positive/human epidermal growth factor receptor 2-negative)

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