Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Capecitabine

Bevacizumab

Docetaxel

Antineoplastic Agents, Immunological

Angiogenesis Inhibitors

Growth Inhibitors

Tubulin Modulators

Antimitotic Agents

bevacizumab [Avastin]

2000mg/m2 po on days 1-15 of each 3 week cycle

Xeloda

Clinical Trials

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.

A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.

"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"

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.

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 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 was defined as the time from the date of informed consent until the date of death due to any cause.

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.

Hoffmann-La Roche

The safety population included all participants who received at least 1 dose of study treatment.

Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m\^2, IV, on Day 1; and capecitabine 2000 mg/m\^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.

Bevacizumab+Docetaxel+Capecitabine

Age, Continuous

Sex: Female, Male

Intent-to-treat (ITT) population. The ITT population included all enrolled participants.

Medical Communications

Evaluable Response (ER) Population: study-eligible participants who completed at least 2 treatment cycles; had lesions evaluated using the same technique at baseline and at least once after receiving the second treatment cycle; and had no major protocol deviation.

Percentage of Participants Achieving Pathological Complete Response (pCR)

Percentage of Participants Achieving an Overall Response of Complete Response (CR) or Partial Response (PR)

The application of a statistical model for the analysis of disease-free survival was not feasible as the sample size required for statistical analysis could not be recruited within the time established in the protocol and the study was terminated.

Progression-Free Survival

The application of a statistical model for the analysis of disease-free survival is not feasible as the sample size required for statistical analysis could not be recruited within the time established in the protocol and the study was terminated.

Overall Survival

Percentage of Participants Undergoing Breast-Conserving Surgery

Participants received bevacizumab 15 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1; docetaxel 75 mg per square meter (mg/m\^2), IV, on Day 1; and capecitabine 2000 mg/m\^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.

Spots Global Cancer Trial Database for A Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) and Docetaxel in Patients With Inflammatory or Locally Advanced Breast Cancer.

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

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Contact Details

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