An Open Label, Randomized Comparison of Femara® 2.5mg Once Daily With or Without Weekly Herceptin® Until Disease Progression as First-line Treatment in Postmenopausal Women With Advanced Breast Cancer.
Phase 4
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Metastatic Breast Cancer
Female
Metastatic Breast Cancer
Trial Information
An Open Label, Randomized Comparison of Femara® 2.5mg Once Daily With or Without Weekly Herceptin® Until Disease Progression as First-line Treatment in Postmenopausal Women With Advanced Breast Cancer.
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.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Time to progression as assessed by clinical palpation and radiologic imaging every 3 months
Outcome Time Frame:
3 months
Safety Issue:
No
Principal Investigator
Novartis Pharmaceuticals
Investigator Role:
Study Director
Investigator Affiliation:
Novartis Pharmeceuticals
Authority:
Germany: Federal Institute for Drugs and Medical Devices
Study ID:
CFEM345C2403
NCT ID:
NCT00171847
Start Date:
March 2003
Completion Date:
Related Keywords:
- Metastatic Breast Cancer
- Breast cancer
- Metastatic
- Trastuzumab
- Letrozole
- Breast Neoplasms
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