PRIMADOS Study:A Study of Avastin (Bevacizumab) Plus Docetaxel for First Line Treatment of Patients With Metastatic Breast Cancer
This study has been withdrawn prior to enrollment.
(Study was put on hold then out of Medical Plan therefore cancelled)
Information provided by (Responsible Party):
First received: October 16, 2008
Last updated: March 2, 2015
Last verified: March 2015
This single arm study will assess the efficacy and safety of first line combination treatment with Avastin + docetaxel in patients with HER2 negative metastatic breast cancer.Patients will receive Avastin (15mg/kg iv every 3 weeks) plus docetaxel (75mg/m2 every 3 weeks for 6 cycles). The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.
Drug: bevacizumab [Avastin]
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||An Open Label Study of the Effect of First Line Combination Treatment With Avastin and Docetaxel on Disease Response in Patients With Metastatic Breast Cancer
Primary Outcome Measures:
- Response rate, median progression free survival, overall survival [ Time Frame: Event driven ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Adverse events [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2013 (Final data collection date for primary outcome measure)
Drug: bevacizumab [Avastin]
15mg/kg iv every 3 weeks
75mg/m2 every 3 weeks for 18 weeks
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- male and female patients, >=18 years of age;
- stage IV, HER2 negative metastatic breast cancer;
- candidate for taxane-based therapy;
- ECOG performance status 0-2.
- prior chemotherapy for metastatic breast cancer;
- concomitant primary malignant disease, except for adequately treated cervical cancer in situ, or basal or squamous cell skin cancer within last 5 years;
- suspicion of CNS metastasis;
- clinically significant cardiovascular disease.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00774241
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||October 16, 2008
||March 2, 2015
||Mexico:Ministry of Health (COFEPRIS)
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on April 23, 2015
Neoplasms by Site
Angiogenesis Modulating Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs