Randomised phase II study of the combination of oral vinorelbine with capecitabine versus gemcitabine in combination with paclitaxel versus gemcitabine in combination with docetaxel as first line chemotherapy in patients with metastatic breast cancer.
- Conditions
- First line chemotherapy in patients with metastatic breast cancerMedDRA version: 7.1Level: LLTClassification code 10027475Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2005-000438-19-DE
- Lead Sponsor
- Pierre Fabre Médicament
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 150
Women with:·
- Age superior at 18 years
- Histologically confirmed adenocarcinoma of the breast
- Documented metastatic disease 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 or non-measurable lesion using the RECIST criteria
- Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) during the 2 months preceding the start of study treatment, throughout the study period and for up to 3 months after the last dose of study treatment and must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment
- Prior chemotherapy as follows:
. adjuvant or neoadjuvant chemotherapy which may contain an anthracycline is allowed and relapsing more than 6 months after the end of chemotherapy
. patient previously treated with 5 FU infusion in adjuvant setting is allowed and relapsing more than 6 months after the end of chemotherapy
- Prior hormonotherapy for neoadjuvant or metastatic breast cancer is allowed
- Patients may have received prior radiotherapy but not on the sites used to assess response. A minimum of 4 weeks interval must have elapsed
- 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 or contra-lateral tumor
- Female is not eligible to enter the study if :
- pregnant or lactating
- with positive pregnancy test at inclusion
- Female of childbearing potential who is unwilling or unable to use a medically accepted method to avoid pregnancy during the 2 months preceding the start of study treatment, throughout the study period andat least 3 months following the last dose of study treatment
- Patients with symptoms suggesting CNS involvement or leptomeningeal metastases
- Concomitant hormonal 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 and oral vinorelbine (Navelbine Orale)
- Prior severe and unexpected reaction to fluoropyrimidine therapy (with or without documented DPD deficiency) or known hypersensitivity to 5-fluorouracil, or patient with a history of hypersensitivity reactions to product containing cremaphorâ
- Prior chemotherapy in the metastatic setting
- Patients previously treated with a vinca-alkaloid, capecitabine, gemcitabine or taxanes
- Current peripheral neuropathy ³ grade 2 according to NCI criteria
- Patients with dysphagia, or inability to swallow the tablets
- Other serious illness or medical conditions: Cardiac disease; Unstable diabetes; Uncontrolled hypercalcemia; Clinically significant active infections; Previous organ allograft
- Requirement for concurrent use of the antiviral agent (sorivudine) or chemically related analogues such a brivudine
- Participation in another clinical trial with any investigational drug within 30 days prior to registration; History of another malignancy within the past five years except basal cell carcinoma of the skin or carcinoma in situ of the cervix.
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