A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With 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.
Drug: bevacizumab [Avastin]
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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"|
- 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) ] [ Designated as safety issue: No ]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.
- Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR) [ Time Frame: Day 1 of Cycles 1-6 ] [ Designated as safety issue: No ]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 [ Time Frame: Cycles 1-6 ] [ Designated as safety issue: No ]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 [ Time Frame: Cycles 1-6 ] [ Designated as safety issue: No ]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 [ Time Frame: Following Cycle 6 ] [ Designated as safety issue: No ]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.
|Study Start Date:||November 2007|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Drug: bevacizumab [Avastin]
15mg/kg iv on day 1 of each 3 week cycleDrug: Docetaxel
75mg/m2 iv on day 1 of each 3 week cycleDrug: Xeloda
2000mg/m2 po on days 1-15 of each 3 week cycle
Please refer to this study by its ClinicalTrials.gov identifier: NCT00576901
|Madrid, Spain, 28041|
|Study Director:||Clinical Trials||Hoffmann-La Roche|