EUCTR2004-000753-30-ESActive, not recruitingPhase 1
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
Pierre Fabre Ibérica S.A. as legal representative of Pierr Fabre Mèdicament0 sites55 target enrollmentStarted: October 7, 2004Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 55
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Investigators
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