Randomized 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 - NORCAP
- Conditions
- First line chemotherapy in pazients HER2 negative with metastatic breast cancerMedDRA version: 14.1Level: PTClassification code 10055113Term: Breast cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2005-000438-19-IT
- Lead Sponsor
- Pierre Fabre Medicament
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 150
Women with: Age =/> 18years; Histologically confirmed adenocarcinoma of the breast; Documented metastatic disease previously untreated with chemoterapy; HER2 negative (assessed by ICH or FISH methods) on the primary tumor or on metastatic site; At least one measurable lesion using the RECIST criteria; Women on childbearing potential must be using a medically accepted method of contraception (oral contraceptives, intrauterine devices)to avoid pregnancy 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 in such a manner to minimise the risk of pregnancy; Negative serum or urine pregnancy test within 72 hours prior to the start of study treatment; Prior chemoterapy as follows: -Adjuvant or neoadjuvant chemotherapy wich 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; Previous hormonotherapy for metastatic breast cancer is allowed; Patients may have received prior therapy but not on the sites used to assess the response. A minimum of 4 weeks interval must have elapsed; Karnofsky Performance Status =/> 70%; Life expectancy =/> 16 weeks; Adequate bone marrow, hepatic and renal functions as evidenced by the following:-Haemoglobin =/> 10 g/dL. -Absolute Neutrophil Count =/> 2 x10^9/L. - Platelet Count >/= 100 x 10^9/L. - Total Bilirubin < ULN (ULN: Upper Limit of Normal). - SGOT/SGPT >/= 2.5 x ULN. -Alkaline Phosphatase < 2.5 x ULN )or < 5ULN in case of bone metastases). -Creatinine clearance >50mL/min (calculated using the Cockroft and Gault formula); Absence of psychological, familiar, sociological or geographic condition potentially hampering compliance with the study protocol and follow-up schedule;these conditions should be assessed with the patient before registration in the trial; The patient must give written (personally signed and dated) informed consent before completing any study-related procedure.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
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 or after conservative treatment or contra-lateral tumor; Female is not eligible to enter the study if: -pregnant or lacating; -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 and at least 3 months following the last dose of study treatment; Patient with symptoms suggesting CNS involvement or leptomeningeal metastases; Concomitant hormonal therapy for metastatic breast cancer; Malabsorbtion syndrome or disease significantly affecting gastrointestinal function or major resection of the stomach or proximal small bowel that could affect absorption of capecitabine and oral vinorelbine; Prior severe and unexspected 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 chremaphor; Prior chemotherapy in the metastatic setting; Patients previously treated with a vinca alkaloid, capecitabine, gemcitabine or taxanes; Current pheripheral neuropathy >/= G2 according to NCI criteria; Patients with dysphagia or inability to swallow the tablets; Other serious illness or medical conditions: a)Cardiac disease, b)Unstable diabetes, c)Uncotrolled hypercalcemia, d)Clinically significant active infections, e) Previous organ allograft; Requirement for concurrent use of the antiviral agent (sorivudine) or chemically related analogues such a brivudine; Paticipation to another clinical trial with any investigational drug within 30 days prior to registration; Hystory 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