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Tipifarnib Plus Letrozole in Advanced Breast Cancer
NCT00050141Phase 2
Key facts
- Status
- Completed
- Start
- Sep 2002
- Primary completion
- Oct 2005
- Countries
- 6
- Sponsor
- Johnson & Johnson
- Modality
- Small Molecules
- Drugs
- tipifarnib
- Conditions
- breast cancer
01
Overview
Phase 2, randomised, double-blind trial in breast cancer comparing Tipifarnib + Letrozole with Placebo + Letrozole (2 arms). Primary endpoint: Confirmed Complete Response (CR) or Partial Response (PR). Started Sep 2002; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Tipifarnib + Letrozole
Tipifarnib 300 mg BID + Letrozole 2.5 mg QD
Placebo + Letrozole
Placebo + Letrozole 2.5 mg QD
03
Who it enrols
Postmenopausal women with ER/PR positive advanced breast cancer progressing after antiestrogen therapy.
04
Endpoints
Primary
Confirmed Complete Response (CR) or Partial Response (PR)
Secondary
Time to Disease Progression
Time to Treatment Failure
Duration of Response
Clinical Benefit
Survival Time
Safety and Tolerability
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