Back to resultsA Study of Herceptin (Trastuzumab) in Combination With Avastin (Bevacizumab) and Sequential Xeloda (Capecitabine) or Docetaxel in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer
Primary Purpose
Breast Cancer
Status
Withdrawn
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
bevacizumab [Avastin]
capecitabine [Xeloda]
docetaxel
trastuzumab [Herceptin]
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- male or female patients, age >/=18 years
- locally recurrent or metastatic HER2-positive breast cancer
- disease progression during or up to 12 months after prior adjuvant therapy with trastuzumab
- LVEF >/=55% at baseline
Exclusion Criteria:
- prior treatment with bevacizumab or capecitabine
- anthracyclines in prior adjuvant or neoadjuvant treatment exceeding cumulative dose of 360mg/m2 for doxorubicin and 720mg/kg for epirubicin
- chronic daily treatment with corticosteroids (>10mg/day methylprednisolone equivalent; excluding inhaled corticosteroids), or aspirin (>325mg/day), or clopidogrel (>75mg/day)
- clinically significant cardiac disease, or cardiac toxicity during previous trastuzumab therapy
- evidence of spinal cord compression or CNS metastasis
- history of other malignancy, unless disease-free for >/=5 years or treated curatively for carcinoma in situ of the cervix or non-melanomatous skin cancer
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Single Arm
Arm Description
Outcomes
Primary Outcome Measures
Progression-Free Survival on second-line treatment
Secondary Outcome Measures
Safety and tolerability: AEs, laboratory parameters, LVEF
Overall Response Rate, Best Overall Response, Duration of Response, Progression-free Survival (first-line), Overall Survival
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00964704
Brief Title
A Study of Herceptin (Trastuzumab) in Combination With Avastin (Bevacizumab) and Sequential Xeloda (Capecitabine) or Docetaxel in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer
Official Title
A Single Arm, Open-label Study to Evaluate the Efficacy on Tumor Response and the Safety of Bevacizumab and Trastuzumab Combination and Sequential Capecitabine in Patients With HER2 +Ive Locally Recurrent or Metastatic Breast Cancer After Early Relapse to Adjuvant Trastuzumab-containing Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Withdrawn
Why Stopped
No patients have been recruited therefore study has been cancelled
Study Start Date
March 2011 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2013 (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 evaluate the safety and efficacy of Herceptin in combination with Avastin and sequential Xeloda in patients with locally recurrent or metastatic HER2-positive breast cancer after early relapse on adjuvant Herceptin therapy. Patients will receive Herceptin at a loading dose of 8mg/kg iv followed by 6mg/kg iv every three weeks, and Avastin 15mg/kg every 3 weeks. At first sign of disease progression Xeloda 1000mg/m2 bid po will be added on days 1-14 of each cycle, or docetaxel (100mg/m2 iv every 3 weeks) if Xeloda is not indicated for a patient. Anticipated time on study treatment is until disease-progression on second line treatment and target sample size is <100.
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 2
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
15mg/kg iv every 3 weeks
Intervention Type
Drug
Intervention Name(s)
capecitabine [Xeloda]
Intervention Description
added at time of disease-progression, 1000mg/m2 bid po days 1-14 of every 3-week cycle
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
background therapy at time of disease progression, 100mg/m2 iv every 3 weeks
Intervention Type
Drug
Intervention Name(s)
trastuzumab [Herceptin]
Intervention Description
8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg every 3 weeks
Primary Outcome Measure Information:
Title
Progression-Free Survival on second-line treatment
Time Frame
event-driven, tumour assessments every 6 weeks for 24 weeks, every 12 weeks thereafter
Secondary Outcome Measure Information:
Title
Safety and tolerability: AEs, laboratory parameters, LVEF
Time Frame
throughout study, laboratory parameters every 3 weeks, LVEF every 12 weeks
Title
Overall Response Rate, Best Overall Response, Duration of Response, Progression-free Survival (first-line), Overall Survival
Time Frame
event-driven, tumour assessment every 6 weeks for 24 weeks, every 12 weeks thereafter
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male or female patients, age >/=18 years
locally recurrent or metastatic HER2-positive breast cancer
disease progression during or up to 12 months after prior adjuvant therapy with trastuzumab
LVEF >/=55% at baseline
Exclusion Criteria:
prior treatment with bevacizumab or capecitabine
anthracyclines in prior adjuvant or neoadjuvant treatment exceeding cumulative dose of 360mg/m2 for doxorubicin and 720mg/kg for epirubicin
chronic daily treatment with corticosteroids (>10mg/day methylprednisolone equivalent; excluding inhaled corticosteroids), or aspirin (>325mg/day), or clopidogrel (>75mg/day)
clinically significant cardiac disease, or cardiac toxicity during previous trastuzumab therapy
evidence of spinal cord compression or CNS metastasis
history of other malignancy, unless disease-free for >/=5 years or treated curatively for carcinoma in situ of the cervix or non-melanomatous skin cancer
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 Herceptin (Trastuzumab) in Combination With Avastin (Bevacizumab) and Sequential Xeloda (Capecitabine) or Docetaxel in Patients With HER2-Positive Locally Recurrent or Metastatic Breast Cancer
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