Back to resultsA Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
bevacizumab [Avastin]
Docetaxel
Xeloda
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Participants Achieving Pathological Complete Response (pCR)
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.
Secondary Outcome Measures
Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)
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.
Progression-Free Survival
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.
Overall Survival
Overall survival was defined as the time from the date of informed consent until the date of death due to any cause.
Percentage of Participants Undergoing Breast-Conserving Surgery
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00576901
Brief Title
A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.
Official Title
"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"
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Terminated
Why Stopped
The sample for statistical analysis of results could not be recruited within the specified timeframe upon retirement of the original principal investigator.
Study Start Date
November 2007 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2009 (Actual)
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 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.
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
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
15mg/kg iv on day 1 of each 3 week cycle
Intervention Type
Drug
Intervention Name(s)
Docetaxel
Intervention Description
75mg/m2 iv on day 1 of each 3 week cycle
Intervention Type
Drug
Intervention Name(s)
Xeloda
Intervention Description
2000mg/m2 po on days 1-15 of each 3 week cycle
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Pathological Complete Response (pCR)
Description
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.
Time Frame
At time of surgery, after receiving up to 6 cycles of treatment (average of 12 to 18 weeks)
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)
Description
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.
Time Frame
Day 1 of Cycles 1-6
Title
Progression-Free Survival
Description
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.
Time Frame
Cycles 1-6
Title
Overall Survival
Description
Overall survival was defined as the time from the date of informed consent until the date of death due to any cause.
Time Frame
Cycles 1-6
Title
Percentage of Participants Undergoing Breast-Conserving Surgery
Description
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.
Time Frame
Following Cycle 6
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
City
Madrid
ZIP/Postal Code
28041
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.
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