None listed
Conditions
Interventions
1) Masking treatment phase: This group will be treated with Bevacizumab at a dose of 15 mg / kg, IV, every 3 weeks, until the progression of the disease, unacceptable toxicity, the researcher s decision to stop the medication, or completion of the maximum duration of treatment with bevacizumab, 24 months. + Standard chemotherapy, which can be any of the following: A) Cohort 1: Taxans every 3 weeks. B) Cohort 2: Chemotherapies based on anthracycline every 3 weeks. C) Cohort 3: 1000 mg / m2 of Cap
1) Treatment phase with masking: This group will be treated with Bevacizumab Placebo, IV, every 3 weeks, until the progression of the disease, unacceptable toxicity, the researcher s decision to stop the medication, or the completion of the maximum duration of treatment with the bevacizumab, 24 months. Standard chemotherapy, which may be any of the following: A) Cohort 1: Taxans every 3 weeks. B) Cohort 2: Chemotherapies based on anthracycline every 3 weeks. C) Cohort 3: 1000 mg / m2 of Capecita
Sponsors
PRODUCTOS ROCHE Q.F.S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1) Measurable or non-measurable breast adenocarcinoma, recurrent localized or metastatic disease, cytologically or histologically confirmed. 2) Have signed the Informed Consent. 3) Age ≥ 18 years. 4) Women with potential fertility will be required to use an accepted and effective non-hormonal contraceptive method. 5) A general state EGOG 0 or 1. 6) Be able to comply with the study and follow-up procedures. 7) Only for the anthracycline cohort: adequate left ventricle function at the beginning of the study. 8) For patients who have recently received radiation therapy: recovery of any important acute toxicity before day 0.
Exclusion criteria
Exclusion criteria: 1) Unknown condition of HER2, or known positive HER2. 2) A treatment prior to the study with chemotherapy for recurrent or metastatic disease. 3) A previous hormonal treatment within 2 weeks prior to day 0. 4) Complementary or pre-surgical prior chemotherapy within 12 months prior to day 0. 5) Only for the anthracycline cohort: treatment with anterior anthracycline as part of a complementary or pre-surgical treatment for localized breast cancer. 6) Experimental treatment within 28 days of day 0. 7) Major surgery, open biopsy, or major traumatic injury within 28 days prior to day 0, or anticipate the need for major surgery during the course of the study. 8) Minor surgeries, such as fine needle punctures or thick needle biopsies, within 7 days prior to day 0. 9) Brain metastases or other known CNS. 10) Blood pressure> 150/100 mmHg. 11) Unstable angina. 12) CHF grade II or higher. 13) Antecedents of myocardial infarction within 6 months prior to day 0. 14) History of cerebrovascular accident or transient ischemic attack within 6 months prior to day 0. 15) Symptomatic peripheral vascular disease. 16) Evidence of hemorrhagic diathesis or coagulopathies. 17) History of abdominal fistula, gastrointestinal perforation or intrabdominal abscess within 6 months prior to day 0. 18) Severe unhealed wounds, ulcers or bone fractures. 19) Pregnancy or lactation. 20) Inadequate organic functioning according to laboratory values. 21) Uncontrolled serious medical or psychiatric diseases. 22) Active infection requiring IV antibiotics on day 0. 23) Antecedents of other malignancies within the 5 years prior to day 0.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Measurement of time from randomization to disease progression or death for any reason during first line treatment. Death during first-line treatment is defined as death within 30 days of the last dose of chemotherapy or study drug. The progression will be evaluated according to the RECIST criteria for breast cancer. Measure:Disease free progression (PFS). Timepoints:When the event is presented, up to 2 years 7 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:1) Overall survival: Evaluation to determine the time from randomization to death for any reason. 2) Objective response: Clinical evaluation to determine the objective response, defined as the complete response (disappearance of all target lesions) or partial response (decrease of at least 30% of the sum of the largest diameter of the target lesions) determined in two consecutive occasions during ≥ 4 weeks of difference. For this, CT, MRI or other imaging techniques will be used. 3) Disease free progression (PFS) in each of the cohorts: Measurement of time from randomization to disease progression or death for any reason during the first line treatment in each cohort. 4) Best answer evaluated by the researcher: Applying the RECIST criteria, to determine when the criteria for the best response of the patient are met. Measure:1) Global survival. 2) Objective response. 3) Disease-free progression (PFS) in each of the cohorts. 4) Best response evaluated by the researcher. Timepoints:1) Overall survival: Up to 30 months. 2) Objective response, disease-free progression and better response evaluated by the researcher: 24 months. ; Outcome name:1) Adverse events: Clinical evaluation according to the Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3.0. 2) Proteinuria: measured according to urinary protein / urine creatinine ratio (in the US) and by means of 24-hour urine dipstick / urine test results (outside the US) 3) Clinical cardiotoxicity: In cohorts receiving chemotherapy with anthracyclines by echocardiography or ventriculography. Measure:Security: 1) Adverse events. 2) Proteinuria. 3) Clinical cardiotoxicity. Timepoints:When the event is presented. | — |
Countries
Australia, Brazil, Canada, France, Greece, Guatemala, Korea South, Mexico, Netherlands, Norway, Panama, Philippines, Russian Federation, Singapore, Spain, Sweden, Taiwan, Ukraine, United Kindgdom, United States, Uruguay
Outcome results
None listed