Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Trial of Fulvestrant with or without Palbociclib +/- Goserelin in Women with Hormone Receptor Positive Breast Cancer Whose Disease Progressed after Prior Endocrine Therapy

Print this page

Multicenter Randomized Double-Blind Placebo-Controlled Phase 3 Trial of Fulvestrant with or without Palbociclib +/- Goserelin in Women with Hormone Receptor Positive Breast Cancer Whose Disease Progressed after Prior Endocrine Therapy

Primary Objective:
To demonstrate the superiority of palbociclib in combination with fulvestrant (with or without goserelin) over fulvestrant (with or without goserelin) alone in prolonging investigator-assessed PFS in women with HR+/HER2- metastatic breast cancer whose disease has progressed on prior endocrine therapy.

Protocol Number041310
Principal InvestigatorDeborah Toppmeyer
PhasePhase III
ScopeNational
Applicable Disease SitesBreast - Female
Therapies InvolvedChemotherapy (NOS)
Drugs InvolvedPalbociclib
FULVESTRANT
Participating InstitutionsRutgers Cancer Institute of New Jersey

For further information on this clinical trial, please contact us at 732-235-8675 or cinjclinicaltrials@umdnj.edu.