Who is sponsoring NCT01942135?

NCT01942135 is sponsored by Pfizer.

What condition does NCT01942135 study?

NCT01942135 studies Metastatic Breast Cancer.

What drugs are being tested in NCT01942135?

Interventions: Palbociclib, Fulvestrant, Placebo, Fulvestrant.

What is the status of NCT01942135?

NCT01942135 is currently COMPLETED.

Last reviewed 2024-04-04 · How we verify

Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)

NCT01942135 PHASE3 COMPLETED Results posted

The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with the primary objective of demonstrating the superiority of palbociclib in combination with fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2 negative metastatic breast cancer whose disease has progressed after prior endocrine therapy. The safety between the two treatment arms will also be compared. During study treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist goserelin (Zoladex® or generic).

Details

Lead sponsor	Pfizer
Phase	PHASE3
Status	COMPLETED
Enrolment	521
Start date	Thu Sep 26 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Wed Sep 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

Metastatic Breast Cancer

Interventions

Palbociclib
Fulvestrant
Placebo
Fulvestrant

Countries

Italy, Japan, Netherlands, Russia, Ukraine, Belgium, Taiwan, Ireland, United Kingdom, Germany, South Korea, Romania, Canada, Australia, Portugal, United States, Turkey (Türkiye)