Study of the Efficacy and Safety of Letrozole Combined With Trastuzumab in Patients With Metastatic Breast Cancer
Phase 4
Terminated
- Conditions
- Metastatic Breast Cancer
- Interventions
- Registration Number
- NCT00171847
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
Phase IV trial to investigate the effect of the combination of Letrozole with trastuzumab in metastatic breast cancer patients
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 93
Inclusion Criteria
- Postmenopausal
- Her-2 overexpression and ER and/or PgR positive
- Metastatic Breast Cancer
Exclusion Criteria
- Previous treatment with trastuzumab
- Significant Liver or renal impairment
- Erbb2 negative and/or ER and PgR negative
Other protocol-defined inclusion / exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description B - HER-2 +ve patients with Femara + Herceptin Trastuzumab plus Letrozole - A - HER-2 +ve patients with Femara alone Letrozole - C - HER-2 -ve patients with Femara alone Letrozole -
- Primary Outcome Measures
Name Time Method Time to progression as assessed by clinical palpation and radiologic imaging every 3 months 3 months
- Secondary Outcome Measures
Name Time Method Duration of response/clinical benefit during treatment 3 months Overall survival 3 months Objective response rate/Clinical Benefit rate 3 months Time to treatment failure 3 months
Trial Locations
- Locations (1)
Novartis Investigative Site
🇩🇪Tuebingen, Germany