None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Vinflunina, at a dose of 320 mg / m2, in an IV infusion, on day 1 of each treatment cycle + Gemcitabine, at a dose of 1000 mg / m2, IV, on days 1 and 8 of each cycle, repeated, every 3 weeks, until the progression of the disease, unacceptable or negative toxicity of the patient to continue with the study.
Group name:GROUP 2 Type of group
This group will be treated with Paclitaxel, at a dose of 175 mg / m2, in a 3-hour IV infusion, followed by Gemcitabine, at a dose of 1250 mg / m2, in a 30-minute IV infusion, on days 1 and 8 of each cycle
This scheme will be administered every 3 weeks, until the progression of the disease, unacceptable or negative toxicity of the patient to continue with the study.
Sponsors
PIERRE FABRE MEDICAMENT,
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients must give written informed consent before performing any procedure related to the study. 2. Women suffering from carcinoma of the breast with histological or cytological confirmation. 3. Locally recurrent or documented metastatic disease not amenable to surgery or radiotherapy with curative intent. 4. Patients with: A) Negative HER-2 disease, assessed by IHC 0-1 + or FISH / CISH negative, in the primary tumor or in the metastatic location. B) Unknown status HER-2. as long as a tumor sample is available for retrospective evaluation. 5. Patients will have received prior adjuvant chemotherapy based on anthracycline with or without a taxane. 6. Previous hormonal treatment is allowed in neoadjuvant and / or adjuvant and in the metastatic setting. 7. Previous radiation therapy is allowed in <25% of the bone marrow and must have been completed at least 4 weeks before randomization. 8. Patients with measurable or non-measurable lesion according to the RECIST criteria. 9. Estimated life expectancy ≥ 12 weeks. 10. Kamofsky´s functional status score ≥ 70%. 11. Age ≥ 18 years and ≤ 75 years. 12. Adequate haematological function. 13. Adequate liver function. 14. Adequate renal function. 15. ECG without clinically important alterations. 16. Women of childbearing potential must use a medically accepted method of contraception during the two months prior to the start of study treatment, during the study period and for up to three months after the last dose of study treatment.
Exclusion criteria
Exclusion criteria: 1. Patients who have received prior chemotherapy for metastatic disease or who have progressed while receiving chemotherapy. 2. Patients with cerebral metastases or leptomeningeal involvement. 3. Inflammatory breast cancer without evidence of metastatic disease. 4. Patients who have received any other experimental treatment or antineoplastic treatment in the 30 days prior to randomization. 5. Concomitant treatment with any other experimental treatment or antineoplastic treatment. 6. History of the second primary malignant tumor. 7. Patients presenting as only tumor lesions any of the following: malignant effusion, lymphangitis, cystic lesions, bone lesions. 8. Patients with a previous existence of peripheral motor or sensory neuropathy of grade> 1 according to the CTCAE criteria version 3.0. 9. Previous therapy with gemcitabine and / or vinca alkaloids. 10. History of serious hypersensitivity to vinca alkaloids and / or gemcitabine and / or taxanes or any contraindication to any of the drugs under study. 11. Pregnant women or breastfeeding women. 12. Patients who present a serious uncontrolled concurrent medical disorder. 13. Previous bone marrow transplant or autologous stem cell infusion after high-dose chemotherapy. 14. Patients in any psychological, family, sociological or geographical situation that may hinder compliance with the study protocol and the follow-up program.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Determination of the time from randomization to the progression of the disease, which is defined as: A) A 20% increase in the sum of the larger diameters of the target lesions or the appearance of one or more new target lesions. B) Appearance of one or more new lesions and / or the unequivocal progression of existing non-target lesions. Measure:Progression Free Survival. Timepoints:Every 6 weeks until the progression of the disease. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Criteria 1 and 5: Determination of the number of patients that achieve the RECIST criteria for partial response (RP), complete response (CR) and stable disease (SE). Criterion 2: Measurement of the time from which some response criterion is reached, until a progressive disease criterion of RECIST is reached. Criterion 3: Calculation of the control rate based on the CR, RP and number of patients. Criterion 4: Determination of time from the date of randomization to the date of failure (progression, relapse, death or withdrawal due to an adverse event, refusal of the patient to continue, loss of follow-up or the start of a new therapy antineoplastic). Criterion 6: Determination of the time from randomization to death for any reason. Measure:Secondary efficacy: 1) Tumor response rate. 2) Duration of the response. 3) Duration of disease control. 4) Time to treatment failure. 5) Time until the first response. 6) Global survival. Timepoints:Every 6 weeks until the progression of the disease. ; Outcome name:Criterion 1: Leukocytes, RAN, platelets, hemoglobin Criterion 2: Determination of a RAN 38.5 ° C of unknown origin Criterion 3: ALT, AST, alkaline phosphatase, creatinine, total bilirubin. Criterion 4: Medical evaluation of any non-haematological adverse event, according to the criteria of the CTCAE, version 3.0. Measure:Safety: 1) Hematological parameters. 2) Febrile neutropenia. 3) Chemical parameters. 4) Non-haematological toxicities. Timepoints:Days 1 and 8 of each cycle and at the end of treatment. ; Outcome name:EORTC Questionnaire QLQ-C30, composed of 30 questions, which evaluates 5 functional scales (physical, role, cognitive, emotional, social) and 9 symptoms (nausea and vomiting, pain, fatigue, dyspnea, insomnia, loss of appetite, constipation, diarrhea , financial difficulties). Questionnaire QLQ-BR23, which evaluates: physical image, sexual function, enjoyment of sexual relations, per | — |
Countries
Australia, Czech Republic, Germany, Italy, Portugal, Spain, United Kindgdom
Contacts
Public ContactEduardo Gotuzzo
PAREXEL INTERNATIONAL (PERU) S.A.
Outcome results
None listed