A Study Evaluating the Efficacy and Safety of Bevacizumab in Combination With Chemotherapy in Untreated Metastatic Breast Cancer (RIBBON 1)
- Conditions
- -C509 Breast, unspecifiedBreast, unspecifiedC509
- Registration Number
- PER-071-06
- Lead Sponsor
- PRODUCTOS ROCHE Q.F.S.A.,
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br>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.<br>Measure:Disease free progression (PFS).<br>Timepoints:When the event is presented, up to 2 years 7 months.<br>
- Secondary Outcome Measures
Name Time Method