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

Antimetabolites

15 mg/kg iv on Day 1 of each 3-week cycle, 5 cycles

bevacizumab [Avastin]

75 mg/m2 on Day 1 of each 3-week cycle, 6 cycles

docetaxel

950 mg/m2, orally twice daily, evening of Day 1 until morning of Day 15, followed by a 7 day rest period, every 3 weeks

capecitabine [Xeloda]

Clinical Trials

This study will evaluate the effect of Avastin (15mg/kg iv) in combination with Docetaxel and Xeloda, given as pre-operative therapy to patients with primary breast cancer. Avastin will be administered every 3 weeks, for the first 5 cycles of chemotherapy. The anticipated time on study treatment is 3-12 months.

A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer

A Phase II Study of Bevacizumab With Docetaxel and Capecitabine in the Neoadjuvant Setting for Breast Cancer Patients

pCR was defined as the absence of signs for invasive tumor in the final surgical sample as judged by the local pathologist. Surgery was performed 2 to 4 weeks after the last chemotherapy cycle.

Percentage of participants with pCR plus the percentage of participants without pCR who achieved CR or PR as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria. 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 axis 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.

Percentage of participants undergoing a breast-conserving procedure versus a modified radical mastectomy at final surgery, performed 2 to 4 weeks after the last chemotherapy cycle (Week 18)

Hoffmann-La Roche

An adverse event is any undesirable event associated with the use of a drug, whether or not considered drug related, and includes any side effect, injury, toxicity, or sensitivity reactions. It also includes any undesirable clinical or laboratory event which is not normally observed in the participant.

Participants received bevacizumab, 15 mg/kg IV, followed by docetaxel 75 mg/m\^2 IV on Day 1 and capecitabine 950 mg/m\^2 PO BID within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.

Bevacizumab+Docetaxel+Capecitabine

Age, Continuous

Sex: Female, Male

Intent-to-treat (ITT) population. All participants who received at least one dose of study drug.

Nonserious adverse events presented in this record include all adverse events reported during the study, not just nonserious events.

Medical Communications

ITT population; participants evaluable for response included those participants who received a minimum of 3 cycles of treatment (9 weeks on study) with final surgery performed and the samples and reports available.

Percentage of Participants With Pathological Complete Response (pCR)

Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR)

Percentage of Participants Undergoing Breast-Conserving Surgery

Participants received bevacizumab, 15 milligrams/kilogram (mg/kg) intravenously (IV), followed by docetaxel 75 mg per square meter (mg/m\^2) IV on Day 1 and capecitabine 950 mg/m\^2 orally (PO) twice daily (BID) within 30 minutes after the end of a meal, starting the evening of Day 1 and continuing until the morning of Day 15 (followed by a 7-day rest period) for a maximum of five 3-week cycles.

Spots Global Cancer Trial Database for A Study of Avastin (Bevacizumab) in Combination With Chemotherapy in Patients With Primary Breast Cancer

Trial Identification

Conditions

Interventions

Study Description

Keywords

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