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Clinical trial

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

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Last updated:25th Sep 2013
Identifier: NCT01942135

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).

Study Type: Interventional  (Clinical Trial)
Actual Enrollment: 521 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date: September 26, 2013
Actual Primary Completion Date: December 5, 2014
Estimated Study Completion Date: January 31, 2019

- Experimental:
Arm A
- Active Comparator: Arm B

Category Value
Date last updated at source 2018-04-12
Study type(s) Interventional
Expected enrolment 521
Study start date 2013-09-26
Estimated primary completion date 2014-12-05

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