Clinical trials are an important way to improve treatment for people with cancer. While most are continuing during the COVID-19 pandemic, the period of time that clinical trials are available and recruiting may change quickly. If you would like to get involved in a clinical trial, speak to your treatment team or the health service where the clinical trial is being undertaken, to confirm it is open and appropriate for you. For cancer information and support, call Cancer Council's experienced cancer nurses on 13 11 20 Monday to Friday from 9am-5pm.

EPIK-B3 : A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (PTEN) Loss Without PIK3CA Mutation

Male or<br/>FemaleGender Male or
Female

Recruitment on holdStatus Recruitment on hold

Systemic<br/>Therapy TrialTypeSystemic
Therapy Trial

ThreePhase Three

18+Age Over 18

Breast<br/>CancersCancer LocationBreast
Cancers

Systemic therapy,Treatment | BreastBreast

Trial Overview Read MoreRead more

This phase III trial is trying to determine whether treatment with a combination of targeted therapy and chemotherapy is safe and effective for patients with advanced triple negative breast cancer.
 

This trial is treating patients with triple negative breast cancer.

This is a systemic therapy trial.

You may be able to join this trial if:

  • Your cancer has spread to other parts of the body.

You may be excluded from this trial if:

  • You have a certain disease or psychological condition.
  • You have had certain treatments, surgical procedures or drugs.

Clinical trials have complex eligibility criteria - talk to your doctor about your interest in this trial.

Clinical Summary Read MoreRead more

Trial Identifiers

Use the hyperlinks, where available to access additional clinical trial information.

Scientific Title

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination With Nab-paclitaxel in Patients With Advanced Triple Negative Breast Cancer With Either Phosphoinositide-3-kinase Catalytic Subunit Alpha (PIK3CA) Mutation or Phosphatase and Tensin Homolog Protein (PTEN) Loss Without PIK3CA Mutation

Commercial Sponsor

Novartis Pharmaceuticals

Summary

This trial is accepting patients with advanced triple negative breast cancer (aTNBC) who carry either a PIK3CA mutation or have PTEN loss without PIK3CA mutation. In this double-blind trial, eligible patients will be randomly selected to receive alpelisib or an alpelisib matching placebo, in combination with intravenous nab-paclitaxel on Days 1, 8 and 15 of a 28-day cycle.

Not Recruiting Hospitals Read MoreRead more

Recruitment on hold

PCCTU (Parkville Cancer Clinical Trials Unit) *
Parkville
Heather Rootes
PCCTU.Breast@petermac.org

Trial Overview: General information about a clinical trial. This section provides an overview of who might be able to join this trial and what type of treatment is involved.

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