Randomised phase II study of the combination of oral vinorelbine with capecitabine versus a sequential regimen of oral vinorelbine and capecitabine versus the combination of docetaxel and capecitabine in patients with metastatic breast cancer previously treated with anthracyclines.
- Conditions
- Patients with metastatic breast cancer previously treated with anthracyclinesMedDRA version: 7.1Level: LLTClassification code 10027475Term: <Manually entered code. Term in E.1.1>
- Registration Number
- EUCTR2004-005205-30-BE
- Lead Sponsor
- Pierre Fabre Medicament
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 135
- Females with histologically or cytologically confirmed adenocarcinoma of the breast and documented metastatic disease
- HER-2 negative disease on the primary tumour or on metastatic site
- At least one measurable lesion according to RECIST
- Prior (neo)-adjuvant chemotherapy (anthracycline-based, unless contraindicated) with at least 12 months of disease-free interval. In case of prior taxane chemotherapy in the (neo) adjuvant setting at least twelve months of disease free interval will be required
- No prior chemotherapy for metastatic disease
- Patients may have received prior radiotherapy but not to the sites used to assess response. A minimum 4-week interval must have elapsed unless the area involved was < 20 % of bone marrow volume in which case the patient may start treatment earlier
- Patients may have had previous hormonal therapy as adjuvant treatment and/or treatment of metastatic disease provided that the patient has progressive disease at study entry. Hormonal therapy must be discontinued prior to study entry
- Women of childbearing potential must be using a medically accepted method of contraception (i.e. oral contraceptives, intrauterine devices) during the treatment and must have a negative serum or urine pregnancy test within 72 hours prior to the start of study treatment
- Age not less than 18 and not more than 75 years
- Life expectancy of at least 3 months
- Karnofsky performance status of 70 or greater
- Adequate haematological, 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
- 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 treatment
- HER-2 positive disease on the primary tumour or on metastatic site
- Prior vinorelbine containing regimen in the (neo)-adjuvant setting
- Patient with life-threatening conditions (i.e. symptomatic lung lymphangitis, rapidly progressive visceral lesions)
- History of another malignancy except appropriately-treated basal cell carcinoma of the skin or carcinoma in situ of the cervix during the last 5 years
- Malabsorption syndrome or disease affecting significantly gastrointestinal tract function
- Concomitant/uncontrolled medical disorder (cardiovascular, hepatic or other systemic disease)
- Patients with brain or leptomeningeal metastases
- Prior severe and unexpected reaction to fluoropyrimidine therapy (which can be explained by DPD deficiency) or known hypersensitivity to 5-fluorouracil, or capecitabine
- Patients with prior history of severe hypersensitivity to drugs formulated with polysorbate 80
- Patients with prior history of high-dose chemotherapy followed by bone marrow or peripheral stem cell support
- Concomitant treatment with sorivudine or its clinically related analogues such as brivudine
- Concurrent treatment with any other anti-cancer therapy
- Patients with pre-existing motor or sensory peripheral neuropathy grade not less than 2 according to NCI criteria
- Male patients.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate simultaneously the response rate of the combination of oral vinorelbine with capecitabine, a sequential regimen of oral vinorelbine and capecitabine, and the combination of docetaxel and capecitabine for first line treatment of patients with metastatic breast cancer, after prior anthracycline containing (neo)- adjuvant regimen;Secondary Objective: - to evaluate the duration of response, the progression-free survival, time-to-treatment failure and overall survival<br>- to evaluate the safety profile in the 3 study arms<br>- to assess the quality of life;Primary end point(s): - Assessment of all lesions every 2 cycles according to RECIST<br>- Assessment of the tumour response rate, duration of responses progression free survival, time to treatment failure and overall survival<br>
- Secondary Outcome Measures
Name Time Method