MedTrace Logo

A Study of Taselisib + Fulvestrant Versus Placebo + Fulvestrant in Participants With Advanced or Metastatic Breast Cancer Who Have Disease Recurrence or Progression During or After Aromatase Inhibitor Therapy

NCT02340221 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 631

Last updated 2022-07-12

Study results available
· View outcomes & findings →

Summary

This international, multicenter, randomized, double-blinded, placebo-controlled study is designed to compare the efficacy and safety of taselisib + fulvestrant with that of placebo + fulvestrant in postmenopausal women with estrogen receptor (ER)-positive, human epidermal growth factor receptor-2 (HER2)-negative, oncogene that encodes for phosphatidylinositol-4,5-bisphosphate 3-kinase (PIK3CA)-mutant, unresectable, locally advanced or metastatic breast cancer after recurrence or progression during or after an aromatase inhibitor (AI) therapy. There will be a 2:1 randomization to the taselisib arm versus the placebo arm. Enrollment will be enriched for participants with PIK3CA mutant tumors via central testing. The anticipated duration of the study is approximately 3.5 years.

Conditions

Interventions

DRUG

Taselisib

Taselisib 4 mg was administered as two tablets of 2 mg each as per the schedule specified in the respective arm.

DRUG

Placebo

Placebo matching to taselisib was administered as per the schedule specified in the respective arm.

DRUG

Fulvestrant

Fulvestrant 500 mg was administered as two IM injections of 250 mg each as per the schedule specified in the respective arms.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-09
Primary Completion
2021-06-29
Completion
2021-06-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Bosnia and Herzegovina
  • Bulgaria
  • Canada
  • China
  • Colombia
  • Czechia
  • Finland
  • France
  • Germany
  • Greece
  • Italy
  • Mexico
  • Netherlands
  • Peru
  • Poland
  • Portugal
  • Romania
  • Russia
  • Serbia
  • South Korea
  • Spain
  • Sweden
  • Taiwan
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02340221 on ClinicalTrials.gov