Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Trial Of Fulvestrant (Faslodex (Registered)). With Or Without Pd-0332991 (Palbociclib) +/- Goserelin In Women With Hormone Receptor-positive, Her2-negative Metastatic Breast Cancer Whose Disease Progressed After Prior Endocrine Therapy

Trial Profile

Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 3 Trial Of Fulvestrant (Faslodex (Registered)). With Or Without Pd-0332991 (Palbociclib) +/- Goserelin In Women With Hormone Receptor-positive, Her2-negative Metastatic Breast Cancer Whose Disease Progressed After Prior Endocrine Therapy

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Oct 2017

At a glance

  • Drugs Fulvestrant (Primary) ; Palbociclib (Primary) ; Goserelin
  • Indications Advanced breast cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms PALOMA-3
  • Sponsors Pfizer
  • Most Recent Events

    • 13 Oct 2017 According to an AstraZeneca media release, the Committee for Medicinal Products for Human Use (CHMP) of the EMA has adopted a positive opinion recommending a new indication for Faslodex (fulvestrant) that will expand its use to include combination therapy with palbociclib. The CHMP opinion is based on data from this trial.
    • 02 Jun 2017 Results presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.
    • 02 Jun 2017 Planned locations also included France, Mexico, South Africa, South Korea, Switzerland as per European Clinical Trials Database.
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