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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