A Study of Avastin (Bevacizumab) in Combination With Taxane-based Chemotherapy as First Line Treatment in Patients With HER-2 Negative Breast Cancer
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
2 other identifiers
interventional
90
1 country
23
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 breast-cancer
Started Jan 2009
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 17, 2009
CompletedFirst Posted
Study publicly available on registry
February 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2013
CompletedResults Posted
Study results publicly available
June 26, 2014
CompletedJuly 23, 2014
July 1, 2014
2.9 years
February 17, 2009
May 27, 2014
July 9, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free Survival
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.
Baseline to the end of the study (up to 2 years 10 months)
Secondary Outcomes (3)
Percentage of Participants With an Objective Response
Baseline to the end of the study (up to 2 years 10 months)
Duration of the Objective Response
Baseline to the end of the study (up to 2 years 10 months)
Overall Survival
Baseline to the end of the study (up to 2 years 10 months)
Study Arms (1)
Bevacizumab + paclitaxel + gemcitabine
EXPERIMENTALParticipants 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.
Interventions
Bevacizumab was supplied as a sterile liquid in glass vials.
Paclitaxel was supplied as a sterile liquid in glass vials.
Gemcitabine was supplied as a sterile liquid in glass vials.
Eligibility Criteria
You may qualify if:
- Female patients, ≥ 18 years of age.
- Breast cancer, with measurable, locally recurrent or metastatic lesions, or patients with bone metastasis only.
- HER-2 negative disease.
- Candidates for chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
You may not qualify if:
- Previous chemotherapy for metastatic or locally advanced breast cancer.
- Previous radiotherapy for treatment of metastatic breast cancer.
- Any prior adjuvant treatment with anthracyclines completed \< 6 months prior to enrollment.
- Chronic daily treatment with corticosteroids (≥ 10 mg/day), aspirin (\> 325 mg/day) or clopidogrel (\> 75mg/day).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Unknown Facility
Elda, Alicante, 03600, Spain
Unknown Facility
Barcelona, Barcelona, 08022, Spain
Unknown Facility
Barcelona, Barcelona, 08907, Spain
Unknown Facility
Manresa, Barcelona, 08243, Spain
Unknown Facility
Burgos, Burgos, 09006, Spain
Unknown Facility
Cadiz, Cadiz, 11009, Spain
Unknown Facility
Córdoba, Cordoba, 14004, Spain
Unknown Facility
Granada, Granada, 18003, Spain
Unknown Facility
Granada, Granada, 18014, Spain
Unknown Facility
Huelva, Huelva, 21005, Spain
Unknown Facility
Jaén, Jaen, 23007, Spain
Unknown Facility
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
Unknown Facility
Lugo, Lugo, 27004, Spain
Unknown Facility
Alcorcón, Madrid, 28922, Spain
Unknown Facility
Madrid, Madrid, 28041, Spain
Unknown Facility
Madrid, Madrid, 28222, Spain
Unknown Facility
Marbella, Malaga, 29600, Spain
Unknown Facility
Murcia, Murcia, 30008, Spain
Unknown Facility
Vigo, Pontevedra, 36214, Spain
Unknown Facility
Seville, Sevilla, 41009, Spain
Unknown Facility
Seville, Sevilla, 41014, Spain
Unknown Facility
Sagunto, Valencia, 46520, Spain
Unknown Facility
Zaragoza, Zaragoza, 50009, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2009
First Posted
February 18, 2009
Study Start
January 1, 2009
Primary Completion
December 1, 2011
Study Completion
January 1, 2013
Last Updated
July 23, 2014
Results First Posted
June 26, 2014
Record last verified: 2014-07