Phase II trial of oral vinorelbine in combination with capecitabine as first line therapy in women with previously untreated HER2 negative metastatic breast cancer. - Not applicable
- Conditions
- Treatment in women with previously untreated HER2 negative metastatic breast cancer.
- Registration Number
- EUCTR2004-000753-30-ES
- Lead Sponsor
- Pierre Fabre Ibérica S.A. as legal representative of Pierr Fabre Mèdicament
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 55
Women with age not less than 18 years,
Documented metastatic breast cancer previously untreated by chemotherapy,
HER2 negative (assessed by 0-1 + IHC or 2+ IHC with FISH-) on the primary tumor or on metastatic site,
At least one measurable lesion using the RECIST criteria,
Karnofsky Performance Status not less than 70%,
Life expectancy not less than 16 weeks,
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 syptoms suggesting CNS involvment or leptomeningeal metastases,
Concomitant hormone therapy for metastaticbreast 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 Main Objective: To evaluate the Overall Response Rate (ORR) of oral vinorelbine (Navelbine Oral) in combination with capecitabine (Xeloda) for HER2 negative patients.;<br> Secondary Objective: - To assess the safety profile of the combination,<br> - To evaluate other efficacy parameters of the combination:<br> - Progression free survival,<br> - Duration of response,<br> - Time to treatment failure,<br> - Overall survival.<br><br> ;Primary end point(s): Evaluation of the Overall Response Rate (ORR) of oral vinorelbine (Navelbine Oral) in combination with capecitabine (Xeloda) for HER2 negative patients.
- Secondary Outcome Measures
Name Time Method