- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00811135
A Study of Avastin (Bevacizumab) in Combination With Herceptin (Trastuzumab) and Xeloda (Capecitabine) in Patients With HER2-Positive Breast Cancer
August 23, 2016 updated by: Hoffmann-La Roche
A Single Arm Open-label, Phase II Study of Bevacizumab in Combination With Trastuzumab and Capecitabine as First-line Treatment of Patients With HER2-positive Locally Recurrent or Metastatic Breast Cancer
This single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic breast cancer.
Patients will receive 3-weekly treatment cycles of Herceptin (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
88
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Herlev, Denmark, 2730
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Vejle, Denmark, 7100
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Aix En Provence, France, 13616
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Beziers, France, 34500
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Creteil, France, 94010
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Dechy, France, 59187
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Lormont, France, 33310
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Marseille, France, 13285
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Narbonne, France, 11780
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Paris, France, 75970
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Paris, France, 75651
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Paris, France, 75475
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Paris, France, 75571
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Rodez, France, 12027
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Saint Jean, France, 31240
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Saint Quentin, France, 02321
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Toulouse, France, 31076
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Moscow, Russian Federation, 115478
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Moscow, Russian Federation, 143423
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Saint-Petersburg, Russian Federation, 197758
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Bratislava, Slovakia, 833 10
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Barcelona, Spain, 08036
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Madrid, Spain, 28040
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Madrid, Spain, 28007
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Malaga, Spain, 29010
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Pontevedra, Spain, 36002
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Salamanca, Spain, 37007
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Sevilla, Spain, 41013
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Valencia, Spain, 46026
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Valencia, Spain, 46010
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Vizcaya
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Barakaldo, Vizcaya, Spain, 48903
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Eskilstuna, Sweden, 63188
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Sundsvall, Sweden, 85186
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Uppsala, Sweden, 75185
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Vaxjo, Sweden, 35185
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- adult patients, >=18 years of age;
- breast cancer with measurable locally recurrent or metastatic lesions;
- candidate for chemotherapy;
- HER2-positive disease;
- ECOG PS of <=2.
Exclusion Criteria:
- previous anticancer therapy for metastatic breast cancer;
- previous radiotherapy for metastatic breast cancer (except for adjuvant radiotherapy >=6 months before enrollment);
- chronic daily treatment with corticosteroids (>=10mg/day), aspirin (>325 mg/day) or clopidogrel (>75mg/day);
- other primary tumor within last 5 years, except for adequately treated cervical cancer in situ, squamous or basal cell skin cancer;
- uncontrolled hypertension or significant cardiovascular disease.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 1
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15mg/kg iv on day 2 of first 3-week cycle,and on day 1 of subsequent cycles
1000mg/m2 bid po on days 1-14 of each 3-week cycle
8mg/kg iv loading dose on day 1 of first 3-week cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR)
Time Frame: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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Tumor response was assessed using the Response Evaluation Criteria in Solid Tumors (RECIST), Version 1.0.
BOR was defined as the best response recorded for a participant from the start of treatment until disease progression/recurrence.
Percentage of participants with a BOR of confirmed CR or PR (responders) was reported.
CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30 percent (%) decrease in the sum of the longest diameter (LD) of target lesions taking as reference the baseline sum LD.
Confirmed responses were those which were confirmed by a repeat assessment, performed 4 weeks after the criteria for response first met.
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Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Number of Participants With Disease Progression or Death
Time Frame: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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Disease progression was defined as at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
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Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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Progression Free Survival (PFS)
Time Frame: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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PFS was defined as the time from enrollment to time of first documented disease progression or death due to any cause, whichever occurred first.
Progression: at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
PFS was estimated using Kaplan-Meier methods.
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Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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Number of Participants With Overall Survival (OS)
Time Frame: Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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OS was defined as the time from enrollment to death from any cause where enrollment was defined as successfully passed screening visit, enrolled in the study and received first dose of study treatment.
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Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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Overall Survival (OS)
Time Frame: Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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OS was defined as the time from enrollment to death from any cause where enrollment was defined as successfully passed screening visit, enrolled in the study and received first dose of study treatment.
OS was estimated using Kaplan-Meier methods.
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Screening until death (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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Number of Participants With Time to Progression (TTP)
Time Frame: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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TTP was defined as the time from enrollment to first documented disease progression (at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions).
TTP was estimated using Kaplan-Meier methods.
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Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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Time to Progression (TTP)
Time Frame: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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TTP was defined as the time from enrollment to first documented disease progression (at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions).
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Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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Number of Participants With Response
Time Frame: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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Participants who had CR or PR were considered as responders.
CR: disappearance of all target and non-target lesions and normalization of tumor marker level; PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
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Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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Duration of Response (DR)
Time Frame: Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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DR was defined as the time from the first recorded response (CR/PR) to the date of first documented progression or death.
CR: disappearance of all target lesions and non-target lesions and normalization of tumor marker level.
PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference the baseline sum LD.
Progression: at least a 20% increase in the sum of LD of target lesions taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions.
DR was estimated using Kaplan-Meier methods.
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Screening until disease progression (assessed at screening, every 6 weeks up to Week 36, thereafter every 9 weeks during treatment period, and then every 3 months during follow-up, up to approximately 4 years)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2008
Primary Completion (ACTUAL)
December 1, 2015
Study Completion (ACTUAL)
December 1, 2015
Study Registration Dates
First Submitted
December 16, 2008
First Submitted That Met QC Criteria
December 17, 2008
First Posted (ESTIMATE)
December 18, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
September 29, 2016
Last Update Submitted That Met QC Criteria
August 23, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Breast Diseases
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Trastuzumab
- Capecitabine
- Bevacizumab
Other Study ID Numbers
- MO21926
- 2008-003283-20
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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