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: 08 Dec 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

    • 16 Nov 2017 According to an Institute of Cancer Research media release, Professor Nicholas Turner, Professor of Molecular Oncology at the ICR is the principle investigator of the study.
    • 14 Nov 2017 According to an AstraZeneca media release, the European Commission (EC) has approved a new indication for Faslodex (fulvestrant) in combination with a CDK4/6 inhibitor, palbociclib, for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer in women who have received prior endocrine therapy.
    • 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.
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