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Palbociclib plus letrozole in ER+/HER2- advanced breast cancer (PALOMA-1)
NCT00721409Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2008
- Primary completion
- Nov 2013
- Countries
- 12
- Sponsor
- Pfizer
- Drugs
- palbociclib
- Conditions
- estrogen receptor-positive breast cancer (ER+)
01
Overview
Phase 2, randomised, open-label trial of palbociclib in estrogen receptor-positive breast cancer (ER+) (2 arms), sponsored by Pfizer. Primary endpoints: Number of Participants With Treatment-Emergent Adverse Events at Phase 1 at 55 months, Number of Participants With Treatment-Related Adverse Events at Phase 1 at 55 months and 2 more. Started Sep 2008; status: completed.
02
Design
2 arms- Study design
- RandomizedOpen-label
Palbociclib + Letrozole
Experimental combination therapy
Letrozole
Active comparator monotherapy
03
Who it enrols
Postmenopausal women with inoperable ER-positive, HER2-negative advanced breast cancer. Phase 2 Part 2 required CCND1 amplification and/or loss of p16. Patients must not have received prior systemic treatment for advanced disease.
04
Endpoints
Primary
Number of Participants With Treatment-Emergent Adverse Events at Phase 1
Number of Participants With Treatment-Related Adverse Events at Phase 1
Number of Participants With Dose Limiting Toxicities at Phase 1
Progression-Free Survival at Phase 2
Secondary
Objective Response Rate at Phase 1
Clinical Benefit Response at Phase 1
Palbociclib Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours
Palbociclib Maximum Observed Plasma Concentration
Palbociclib Time to Maximum Plasma Concentration
Palbociclib Terminal Plasma Half-life
Palbociclib Apparent Clearance
Palbociclib Apparent Volume of Distribution
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