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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00774241
• Other study ID #: ML21343
• Status: Withdrawn
• Phase: Phase 4
• First received: October 16, 2008
• Last updated: November 1, 2016
• Start date: January 2010
• Est. completion date: November 2013

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico:Ministry of Health (COFEPRIS)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• bevacizumab [Avastin]
15mg/kg iv every 3 weeks
• docetaxel
75mg/m2 every 3 weeks for 18 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate, median progression free survival, overall survival		Event driven	No
Secondary	Adverse events		Throughout study	No