Study of Safety and Efficacy of Letrozole Monotherapy as Second-line Endocrine Therapy in Postmenopausal Patients With Advanced Breast Cancer Who Received Previous Anti-estrogen Treatment
NCT00237198 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 47
Last updated 2017-02-23
Summary
* Safety and efficacy of letrozole 2.5 mg/day monotherapy as second-line endocrine therapy in postmenopausal patients with advanced breast cancer who received previous anti-estrogen treatment
* To investigate changes in blood drug concentrations and blood hormone kinetics.
* To investigate gene polymorphisms of CYP2A6, an enzyme involved in the metabolism of letrozole
Conditions
- Postmenopausal Women With Advanced Breast Cancer
Interventions
- DRUG
Sponsors & Collaborators
-
Chugai Pharmaceutical
collaborator INDUSTRY - lead INDUSTRY
Principal Investigators
-
Novartis Pharmaceuticals · Novartis Pharmaceuticals
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 20 Years
- Max Age
- 79 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2004-03-31
- Primary Completion
- 2006-07-31
Countries
- Japan
Study Locations
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