A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer
This single-arm study assessed the efficacy and safety of first-line treatment with Avastin (bevacizumab) in combination with taxane-based chemotherapy (paclitaxel and gemcitabine) in patients with HER-2 negative breast cancer. Patients received Avastin 10 mg/kg iv, paclitaxel 150 mg/m^2 iv, and gemcitabine 200 mg/m^2 iv on Day 1 and Day 15 of each 4-week treatment cycle until disease progression, death, or withdrawal of consent.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||An Open Label Study to Assess the Effect of First Line Treatment With Avastin in Combination With Paclitaxel and Gemcitabine in Progression-free Survival in Patients With HER-2 Negative Breast Cancer|
- Progression-free Survival [ Time Frame: Baseline to the end of the study (up to 2 years 10 months) ] [ Designated as safety issue: No ]Progression-free survival was defined as the time from enrollment in the study to the first documented disease progression using Response Evaluation Criteria In Solid Tumors (RECIST) or death from any cause, whichever occurred first.
- Percentage of Participants With an Objective Response [ Time Frame: Baseline to the end of the study (up to 2 years 10 months) ] [ Designated as safety issue: No ]An objective response was defined as a complete or partial response determined on 2 consecutive occasions ≥ 4 weeks apart using Response Evaluation Criteria in Solid Tumors (RECIST). Complete response was defined as the disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must be < 10 mm on the short axis. Partial response was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum.
- Duration of the Objective Response [ Time Frame: Baseline to the end of the study (up to 2 years 10 months) ] [ Designated as safety issue: No ]Duration of the objective response is defined as the time from a complete or partial response to disease progression or death due to disease.
- Overall Survival [ Time Frame: Baseline to the end of the study (up to 2 years 10 months) ] [ Designated as safety issue: No ]Overall survival is defined as the time from the first dose of study medication until death.
|Study Start Date:||January 2009|
|Study Completion Date:||January 2013|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Experimental: Bevacizumab + paclitaxel + gemcitabine
Participants received bevacizumab 10 mg/kg intravenously (IV), paclitaxel 150 mg/m^2 IV, and gemcitabine 2000 mg/m^2 IV on Day 1 and Day 15 of each 4-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
Bevacizumab was supplied as a sterile liquid in glass vials.
Other Name: AvastinDrug: Paclitaxel
Paclitaxel was supplied as a sterile liquid in glass vials.
Other Name: TaxolDrug: Gemcitabine
Gemcitabine was supplied as a sterile liquid in glass vials.
Other Name: Gemzar
Please refer to this study by its ClinicalTrials.gov identifier: NCT00846027
|Elda, Alicante, Spain, 03600|
|Manresa, Barcelona, Spain, 08243|
|Cádiz, Cadiz, Spain, 11009|
|Las Palmas de Gran Canaria, Las Palmas, Spain, 35016|
|Alcorcon, Madrid, Spain, 28922|
|Marbella, Malaga, Spain, 29600|
|Vigo, Pontevedra, Spain, 36214|
|Sagunto, Valencia, Spain, 46520|
|Barcelona, Spain, 08022|
|Barcelona, Spain, 08907|
|Burgos, Spain, 09006|
|Cordoba, Spain, 14004|
|Granada, Spain, 18003|
|Granada, Spain, 18014|
|Huelva, Spain, 21005|
|Jaen, Spain, 23007|
|Lugo, Spain, 27004|
|Madrid, Spain, 28041|
|Madrid, Spain, 28222|
|Murcia, Spain, 30008|
|Sevilla, Spain, 41009|
|Sevilla, Spain, 41014|
|Zaragoza, Spain, 50009|
|Study Director:||Clinical Trials||Hoffmann-La Roche|