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

Sponsor
Hoffmann-La Roche
Study ID
NCT00774241
Phase
PHASE4
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

First listed
Oct 17, 2008
Start date
Jan 31, 2010
Status verified
Nov 2016
Primary completion
Nov 30, 2013
Completion
Nov 30, 2013

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 1

Primary Outcome Measure

Response rate, median progression free survival, overall survival [ Time Frame: Event driven ]

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