Back to resultsA Study of The Safety Profile of First-line Avastin (Bevacizumab) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Her2-negative Breast Cancer (AVATAX)
Primary Purpose
Breast Cancer
Status
Withdrawn
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
bevacizumab [Avastin]
paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Adult patients, >/= 18 years of age
- Locally recurrent or metastatic Her2-negative breast cancer
- Locally recurrent disease must not be amenable to radiation therapy or resection with curative intent
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Prior Adjuvant chemotherapy allowed; if taxane-based a disease-free interval after completion of >/=12 months is required
- Adequate haematological, renal and liver function
Exclusion Criteria:
- Previous chemotherapy for locally recurrent or metastatic disease
- Radiation therapy for metastatic disease (except for relief of metastatic bone pain with irradiation of </= 30% of marrow-bearing bone)
- CNS metastases
- Pre-existing peripheral neuropathy
- Clinically significant cardiovascular disease
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
Safety profile: Adverse events
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01156961
Brief Title
A Study of The Safety Profile of First-line Avastin (Bevacizumab) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Her2-negative Breast Cancer (AVATAX)
Official Title
Post Registration Observational Program for Patients With Locally Recurrent or Metastatic Breast Cancer Who Receive Bevacizumab (Avastin) in Combination With Paclitaxel for the First-line Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Absence of patient's recruitment in the study due to administrative reasons
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This single arm, open label study will assess the safety profile of Avastin (bevacizumab) in combination with paclitaxel as first-line treatment in patients with locally recurrent or metastatic Her2-negative breast cancer. Patients will receive Avastin, either 10 mg/kg intravenously (iv) every 2 weeks or 15 mg/kg iv every 3 weeks. Correspondingly, paclitaxel will be administered at a dose of 90 mg/m2 o days 1, 8 and 15 of every 28-day cycle or 175 mg/m2 on day 1 of every 21-day cycle. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
10 mg/kg iv every 2 weeks or 15 mg/kg iv every 3 weeks
Intervention Type
Drug
Intervention Name(s)
paclitaxel
Intervention Description
90 mg/m2 iv days 1, 8 and 15 of every 28-day cycle or 175 mg/m2 iv day 1 of each 21-day cycle
Primary Outcome Measure Information:
Title
Safety profile: Adverse events
Time Frame
approximately 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult patients, >/= 18 years of age
Locally recurrent or metastatic Her2-negative breast cancer
Locally recurrent disease must not be amenable to radiation therapy or resection with curative intent
Eastern Cooperative Oncology Group (ECOG) performance status 0-2
Prior Adjuvant chemotherapy allowed; if taxane-based a disease-free interval after completion of >/=12 months is required
Adequate haematological, renal and liver function
Exclusion Criteria:
Previous chemotherapy for locally recurrent or metastatic disease
Radiation therapy for metastatic disease (except for relief of metastatic bone pain with irradiation of </= 30% of marrow-bearing bone)
CNS metastases
Pre-existing peripheral neuropathy
Clinically significant cardiovascular disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Study of The Safety Profile of First-line Avastin (Bevacizumab) in Combination With Paclitaxel in Patients With Locally Recurrent or Metastatic Her2-negative Breast Cancer (AVATAX)
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