- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00576901
A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.
July 17, 2014 updated by: Hoffmann-La Roche
"An Open Label Study to Assess the Effect of Neoadjuvant Treatment With Docetaxel + Xeloda + Avastin on Pathological Response Rate in Inflammatory or Locally Advanced Breast Cancer"
This single arm study will assess the efficacy and safety of combination first-line treatment with docetaxel + Xeloda + Avastin in patients with inflammatory or locally advanced breast cancer.
Patients will receive 3-weekly cycles of Avastin (15mg/kg i.v. on day 1 of each cycle), docetaxel (75mg/m2 i.v. on day 1 of each cycle, after Avastin) and Xeloda (2000mg/m2 p.o. on days 1-15 of each cycle).
Four cycles of chemotherapy are planned, plus an optional additional two cycles; after chemotherapy patients will be assessed for surgery.
The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
23
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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Madrid, Spain, 28041
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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
Female
Description
Inclusion Criteria:
- female patients, >=18 years of age;
- HER2-negative, locally advanced (stage II or III) or inflammatory cancer of the breast;
- ECOG performance status 0-1.
Exclusion Criteria:
- metastatic disease (stage IV);
- previous treatment for breast cancer;
- evidence of CNS metastasis;
- current or recent (within 10 days of first dose of Avastin) use of aspirin (>325mg/day) NSAIDs or full dose anticoagulants for therapeutic purposes;
- clinically 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: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
|
15mg/kg iv on day 1 of each 3 week cycle
75mg/m2 iv on day 1 of each 3 week cycle
2000mg/m2 po on days 1-15 of each 3 week cycle
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving Pathological Complete Response (pCR)
Time Frame: At time of surgery, after receiving up to 6 cycles of treatment (average of 12 to 18 weeks)
|
pCR was defined as the absence of viable tumor cells, as determined by standard histologic procedure, in the tumor specimen (including regional lymph nodes) obtained at surgery.
In order to minimize evaluation bias, tumor specimens were analyzed by both a central and local pathologist.
The number of participants with pathological tumor stage 0 (pT0) and regional lymph nodes stage 0 (pN0) at surgery was determined.
pCR was defined as the number of participants with pT0 and pN0 at surgery divided by the total number of participants with pathological tumor stage data collected.
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At time of surgery, after receiving up to 6 cycles of treatment (average of 12 to 18 weeks)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)
Time Frame: Day 1 of Cycles 1-6
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The percentage of participants with a best overall response of CR or PR according to Response Evaluation Criteria in Solid Tumors (RECIST).
CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease.
All nodes, both target and non-target, must have decreased to normal (short axis less than [<]10 millimeters [mm]).
No new lesions.
PR was defined as greater than or equal to (≥) 30 percent (%) decrease under baseline of the sum of diameters of all target lesions.
The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.
No unequivocal progression of non-target disease.
No new lesions.
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Day 1 of Cycles 1-6
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Progression-Free Survival
Time Frame: Cycles 1-6
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Progression-free survival was defined as the time from the date of informed consent until the date disease progression was identified, or the date of death from disease progression, whichever occurred first.
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Cycles 1-6
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Overall Survival
Time Frame: Cycles 1-6
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Overall survival was defined as the time from the date of informed consent until the date of death due to any cause.
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Cycles 1-6
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Percentage of Participants Undergoing Breast-Conserving Surgery
Time Frame: Following Cycle 6
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The percentage of participants who were able to undergo breast-conserving surgical procedures (segmentectomy plus lymphadenectomy or quadrantectomy plus lymphadenectomy) rather than non-breast conserving procedures (radical mastectomy or modified-radical mastectomy) following 4 or more treatment cycles.
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Following Cycle 6
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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
November 1, 2007
Primary Completion (Actual)
June 1, 2009
Study Completion (Actual)
June 1, 2009
Study Registration Dates
First Submitted
December 18, 2007
First Submitted That Met QC Criteria
December 18, 2007
First Posted (Estimate)
December 19, 2007
Study Record Updates
Last Update Posted (Estimate)
August 11, 2014
Last Update Submitted That Met QC Criteria
July 17, 2014
Last Verified
July 1, 2014
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
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Docetaxel
- Bevacizumab
Other Study ID Numbers
- ML20561
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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