Phase II trial of oral vinorelbine in combination with capecitabine and trastuzumab as first line therapy in women with previously untreated HER2 positive metastatic breast cancer. - Not applicable
- Conditions
- Treatment in women with previously untreated HER2 positive metastatic breast cancer.
- Registration Number
- EUCTR2004-000748-26-ES
- Lead Sponsor
- Pierre Fabre Ibérica, S.A. en representación de Pierre Fabre Mèdicament
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 55
Women with age not less than 18 years,
Documented metastatic breast disease previously untreated by chemotherapy,
HER2 positive (assessed by 3+IHC or FISH+) on the primary tumor or on metastatic site,
At least one measurable lesion using the RECIST criteria,
Be ambulatory with a Karnofsky Performance Status not less than 70%,
Life expectancy not less than 16 weeks,
Normal cardiac function, LVEF not less than 50% as measured by MUGA scan or ultrasound,
Adequate bone marrow, hepatic and renal functions.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Local relapse alone after conservative treatment of contra-lateral tumor,
Pregnant or lactating women,
Patient with symptoms suggesting CNS involvment or leptomeningeal metastases,
Concomitant hormone therapy for metastatic breast cancer,
Malabsorption syndrome or disease significantly affecting gastro-intestinal function or major resection of the stomach or proximal small bowel that could affect absorption of capecitabine (Xeloda) and oral vinorelbine (Navelbine Oral),
Other serious illness or medical conditions.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method