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.

AMEERA-5 : A Randomized, Multicenter, Double-blind Phase 3 Study of SAR439859 Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease

Male or<br/>FemaleGender Male or
Female

RecruitingStatus Recruiting

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 find the best combination of cancer drugs (SAR439859 + palbociclib, compared to letrozole + palbociclib) to improve survival in patients with ER+, HER2- advanced breast cancer who have not received prior treatment for advanced disease.
 

This trial is treating patients with ER+, HER2- breast cancer.

This is a systemic therapy trial.

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 Randomized, Multicenter, Double-blind Phase 3 Study of SAR439859 Plus Palbociclib Versus Letrozole Plus Palbociclib for the Treatment of Patients With ER (+), HER2 (-) Breast Cancer Who Have Not Received Prior Systemic Anti-cancer Treatment for Advanced Disease

Commercial Sponsor

Sanofi Aventis

Summary

Eligible patients will be randomised to receive a continuous dose of either SAR439859 or Letrozole once-daily, in combination with a dose of Palbociclib once daily on days 1-21 of every 28-day cycle. Goserelin may also be administered once every 4 weeks in pre/peri menopausal women and men.

Recruiting Hospitals Read MoreRead more

Epworth Freemasons, Medical Oncology
East Melbourne
Mr Dave McKee
dave.mckee@epworth.org.au
03 9936 8043

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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