Phase III study of vinflunine plus gemcitabine versus paclitaxel plus gemcitabine in patients with unresectable, locally recurrent or metastatic breast cancer after prior anthracycline-based adjuvant chemotherapy - Vinflunine/gemcitabine Vs. paclitaxel plus gemcitabine in metastatic breast cancer
- Conditions
- Treatment of patients with unresectable, locally recurrent or metastatic breast cancer after prior anthracycline-based adjuvant chemotherapy or if contraindicated, a non-anthracycline based chemotherapy.MedDRA version: 13.1 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
- Registration Number
- EUCTR2006-001139-23-GB
- Lead Sponsor
- PIERRE FABRE Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 994
- Patient must given written informed consent (personnaly dated and signed)
- Age between 18 and 75 years old
- Woman with histologically or cytologically confirmed carcinoma of the breast
- Woman of chilbearing potential must be using a medically accepted method of contraception to avoid pregancy 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. Woman of childbearing potential must have a negative serum or urine pregnancy test within 72 hours prior to first treatment administration
-Documented locally recurrent or metastatic disease not amenable to curative surgery or radiotherapy.
- Patient with eiter HER-2 negative disease assessed by IHC 0-1+ or FISH/CISH negative, on the primary tumour or on metastatic site, or HER-2 status unknown, provided that a tumour sample is available for retrospective review, if relevant.
- Patient must have received a prior neo-adjuvant and/or adjuvant anthracycline based chemotherapy ( or if contraindicated, a non-anthracycline based chemotherapy) with or without a taxane. The disease free interval from completion of the prior chemotherapy must be more than 12 months.
- Prior hormone therapy is allowed either in the neoadjuvant and/or adjuvant setting and in the metastatic setting provided that there is a documented progression of the disease ant the treatment must be terminated prior to randomisation.
- Prior radiation therapy allowed to inferior25% of the bone marrow and must be completed at least 4 weeks before randomisation.
- Patient with measurable or non-measurable lesion usong the RECIST guidelines.
- Estimated life expectancy superior or equal to 12 weeks.
- Karnofsky performance score > or = 70%
- Adequate haematological function (within 7 days before first study treatment): ANC >or=1,5 x 109/L, platelet count >or =100 x 109/L and haemaglobin >or=10 g/dL.
- Adequate hepatic function (within 7 days before first study treatment): Total bilirubin - Adequate renal function (within 7 days before first treatment administration): creatinine level within normal values or, in case of creatinine level > ULN, calculated creatinine clearance >or= 60 mL/min according to Cockroft-Gault formula.
- ECG without clinically relevant modification (within 7 days before first treatment administration).
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
- Patient having received previous chemotherapy for metastatic disease or having progressed while on adjuvant chemotherapy or within 12 months from completion of adjuvant chemotherapy.
- Patient with known or with clinical evidence of brain metastatic or leptomeningeal involment.
- Inflammatory breast cancer without evidence of metastatic disease.
- Patient having received any other experimental or anti-cancer therapy within 30 days before randomisation, except hormone therapy
- History of second primary malignancy, except: bilateral breast carcinoma, in situ carcinoma of the cervix, adequately treated non melanomatous carcinoma of the skin, or other malignancy treated at least 5 years previously with no evidence of recurrence.
- Patient having as the sole tumour lesion, any of the following: malignant effusion, lymphangitis, cystic lesion, bone lesion and any other lesion that is not assessed by imaging techniques or colour photography.
- Patient with pre-existing motor or sensory peripheral neuropathy of CTCAE version 3.0 grade >1.
- History of severe hypersensitivity to vinca alkaloids and/or gemcitabine and/or taxanes or any contraindication to any of the study drugs.
- Pregnant or breast feeding woman.
- Patient who had a serious, concurrent uncontrolled medical disorder especially uncontrolled hypercalcaemia, congestive heart failure, uncontrolled high-risk hypertension, arrhythmia, angina pectoris or previous history of myocardial infarction within 6 months prior to randomisation.
- Prior bone marrow transplantation or autologous stem cell infusion following high-dose chemotherapy.
- Prior therapy with gemcitabine and/or vinca alkaloids.
- Patients with any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; and patients under guardianship (e.g. individuals who are not able to freely give their informed consent). These conditions should be assessed with the patient before randomisation.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary end point(s): - Progression-free survival will be calculated from the date of randomisation until the date of progression or death (whatever the reason of death). ;Main Objective: To show that the vinflunine plus gemcitabine test arm is non inferior to the paclitaxel plus gemcitabine control arm in terms of progression-free survival. If non inferiority is claimed after this first test, a second test will be performed in order to show that the vinflunine plus gemcitabine arm is superior to the paclitaxel plus gemcitabine arm in terms of progression-free survival.;<br> Secondary Objective: To compare between the 2 treatment arms:<br> - the tumour response rate,<br> - the duration of response, duration of disease control, time to treatment failure and time to first response,<br> - the overall survical,<br> - the safety profile,<br> - the health-related quality of life through a QOL questionnaire.<br>
- Secondary Outcome Measures
Name Time Method