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PRIMADOS Study:A Study of Avastin (Bevacizumab) Plus Docetaxel for First Line Treatment of Patients With Metastatic Breast Cancer

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ClinicalTrials.gov Identifier: NCT00774241
Recruitment Status : Withdrawn (Study was put on hold then out of Medical Plan therefore cancelled)
First Posted : October 17, 2008
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: bevacizumab [Avastin] Drug: docetaxel Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : January 2010
Estimated Primary Completion Date : November 2013
Estimated Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: bevacizumab [Avastin]
15mg/kg iv every 3 weeks
Drug: docetaxel
75mg/m2 every 3 weeks for 18 weeks


Outcome Measures

Primary Outcome Measures :
  1. Response rate, median progression free survival, overall survival [ Time Frame: Event driven ]

Secondary Outcome Measures :
  1. Adverse events [ Time Frame: Throughout study ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00774241


Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00774241     History of Changes
Other Study ID Numbers: ML21343
First Posted: October 17, 2008    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Bevacizumab
Docetaxel
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action