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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: bevacizumab [Avastin]; Drug: docetaxel; Drug: capecitabine [Xeloda]

• Registration Number: NCT02005549
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Study First Submitted: 2013-12-04
• Study First Submitted QC: 2013-12-04
• Study First Posted: 2013-12-09
• Status Verified: 2014-05
• Results First Submitted: 2014-05-07
• Results First Submitted QC: 2014-05-07
• Results First Posted: 2014-06-06
• Last Update Submitted: 2014-06-30
• Last Update Posted: 2014-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 18

Inclusion Criteria

• female patients, 18-70years of age;
• histologically-proven invasive breast cancer;
• no prior or current neoplasm except for non-melanoma skin cancer, or in situ cancer of the cervix;
• no distant disease/secondary cancer.

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Exclusion Criteria

• pregnant or lactating women;
• pre-operative local treatment for breast cancer;
• prior or concurrent systemic antitumor therapy;
• clinically significant cardiac disease.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Neoadjuvant Therapy	bevacizumab [Avastin]	-
Neoadjuvant Therapy	docetaxel	-
Neoadjuvant Therapy	capecitabine [Xeloda]	-

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Pathological Complete Response (pCR)	Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR)	Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])	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 Breast-Conserving Surgery	20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])	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)