This site is intended for healthcare professionals
  • Home
  • /
  • Clinical trials
  • /
  • Uncategorised Disease
  • /
  • A Study of Ipatasertib in Combination With Paclita...
Clinical trial

A Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Participants With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer (IPATunity130)

Read time: 3 mins
Last updated:6th Jan 2018
Identifier: NCT03337724

This study will evaluate the efficacy of ipatasertib + paclitaxel versus placebo + paclitaxel in participants with histologically confirmed, locally advanced or metastatic triple-negative breast cancer (TNBC) and in participants with locally advanced or metastatic hormone receptor positive (HR+)/ human epidermal growth factor receptor 2 negative (HER2−) breast adenocarcinoma who are not suitable for endocrine therapy.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Randomized Phase III Study of Ipatasertib in Combination With Paclitaxel as a Treatment for Patients With PIK3CA/AKT1/PTEN-Altered, Locally Advanced or Metastatic, Triple-Negative Breast Cancer or Hormone Receptor-Positive, HER2-Negative Breast Cancer
Actual Study Start Date: January 6, 2018
Estimated Primary Completion Date: December 22, 2021
Estimated Study Completion Date: December 22, 2021

Arms:
- Experimental:
Ipatasertib + Paclitaxel
- Experimental: Placebo + Paclitaxel

Category Value
Date last updated at source 2019-06-04
Study type(s) Interventional
Expected enrolment 450
Study start date 2018-01-06
Estimated primary completion date 2021-12-22

View full details