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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02005549
• Other study ID #: ML19869
• Status: Completed
• Phase: Phase 2
• First received: December 4, 2013
• Last updated: June 30, 2014
• Start date: February 2006
• Est. completion date: April 2008

Study information

• Verified date: May 2014
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Austrian Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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.

Exclusion Criteria:

• pregnant or lactating women;

• pre-operative local treatment for breast cancer;

• prior or concurrent systemic antitumor therapy;

• clinically significant cardiac disease.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• bevacizumab [Avastin]
15 mg/kg iv on Day 1 of each 3-week cycle, 5 cycles
• docetaxel
75 mg/m2 on Day 1 of each 3-week cycle, 6 cycles
• capecitabine [Xeloda]
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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Pathological Complete Response (pCR)	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.	Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])	No
Secondary	Percentage of Participants With pCR, Clinical Complete Response (CR), or Clinical Partial Response (PR)	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.	Baseline, 20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])	No
Secondary	Percentage of Participants Undergoing Breast-Conserving Surgery	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)	20-24 weeks (final surgery, performed 2 to 4 weeks after the last chemotherapy cycle [Week 18])	No