Phase III trial of IV vinflunine versus an alkylating agent in patients with metastatic breast cancer previously treated with or resistant to an anthracycline, a taxane, an antimetabolite, and a vinca-alkaloid (study L00070 IN 308 B0)
- Conditions
- -C50 Malignant neoplasm of breastMalignant neoplasm of breastC50
- Registration Number
- PER-077-10
- Lead Sponsor
- PIERRE FABRE MEDICAMENT,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 0
• Patients must give written informed consent (signed and dated personally) before performing any procedure related to the study.
• Women with histologically or cytologically confirmed breast carcinoma
• Documented metastatic disease not susceptible to surgery or radiotherapy with curative intent
• Patients must have received at least two previous chemotherapy regimens for the treatment of locally recurrent and / or metastatic disease, excluding chemotherapy received in the neo / adjuvant setting
• The above treatments must have included an anthracycline, a taxane, an antimetabolite and a vinca alkaloid (except vinflunine) in any combination or order. Patients may have received ixabepilone in countries where the drug was registered.
• Patients should not be suitable for treatment with anthracyclines, taxanes, antimetabolites and vinca alkaloids (except vinflunine)
• Patients should have received the last dose of vinca alkaloid more than 4 months before randomization.
• Patients may have been treated with previous hormonal anticancer therapy, but are no longer considered candidates for subsequent hormonal therapy.
• Patients with positive Her-2 tumors may have been treated with targeted anti-Her 2 therapy (eg trastuzumab, lapadnib) and should have discontinued treatment at least 3 weeks before randomization
• Prior radiation therapy is allowed and must have ended at least 3 weeks before randomization
• Measurable or non-measurable disease according to the KECIST criteria (version 1.1)
• Estimated life expectancy> 12 weeks
• WHO functional status <2
• Age> 18 years and <75 years
• Adequate hematological function: absolute neutrophil count (RAN)> 1.5 x 10 ^ 9 / L, platelets> 100 X 10 ^ 9 / L, hemoglobin> 10g / dl. (Transfusions are not allowed during the month prior to the first administration of the study medication, unless medically indicated.)
• Adequate liver function: transaminase <2.5 x Upper Normal Limit (LSN) (<5 x LSN in case of liver metastases), total bilirubin <1.5 x LSN, alkaline phosphatase <5 x LSN
• Adequate renal function: creatinine <1.5 x LSN or calculation of creatinine clearance (Cockroft-Gault)> 50 ml / min
• Women of childbearing age should use a medically accepted contraceptive method (barrier methods, intrauterine devices) to prevent pregnancy during the two months prior to the start of the study treatment, during the study period and up to three months after the last dose of the treatment under study, so that the risk of pregnancy is minimized. Women of childbearing age should obtain a negative test result in serum or urine pregnancy within 72 hours prior to the first administration of treatment.
• The patient must have access to the public health system if appropriate in accordance with local legislation
• Absence of any psychological, family, sociological or geographical situation that could potentially hinder compliance with the protocol under study and the monitoring program; These situations should be assessed with the patient before registration in the trial.
• Patients with pulmonary lymphangitis or symptomatic pleural effusion (grade> 2) that causes pulmonary dysfunction that requires active treatment or symptomatic ascites (grade> 2) that requires paracentesis.
• Patients with meningeal carcinomatosis
• Patients with metastases in the central nervous system, unless the patient has completed local treatment, the CT scan indicates stability for at least 4 weeks without signs of cerebral edema and does not need corticosteroids or anticonvulsants
• Patients who have received any other experimental treatment or antineoplastic treatment within 30 days prior to randomization, except for hormonal treatment
• Patients who have participated in a previous clinical trial with vinflunine
• History of a second primary malignant tumor, except bilateral breast carcinoma, in situ carcinoma of the cervix, properly treated non-melanomatous cutaneous carcinoma and another malignant tumor treated, at least 5 years before without evidence of recurrence
• Patients with prior peripheral motor / sensory neuropathy of grade> 1 according to CTCAE version 3.0
• History of severe hypersensitivity to vinca alkaloids and / or alkylating agents or any contraindication to any of the drugs under study
• Known history of HIV infection
• Pregnant or breastfeeding women
• Patients presenting with a serious uncontrolled concurrent medical disorder, especially uncontrolled hypercalcemia, congestive heart failure, uncontrolled high risk hypertension, arrhythmia, angina pectoris or previous history of myocardial infarction in the 6 months prior to randomization
• Previous history of high-dose chemotherapy with bone marrow transplantation or autologous stem cell infusion
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method