Status:
COMPLETED
A Study of Bevacizumab (Avastin) in Combination With Neoadjuvant Treatment Regimens in Participants With Primary Human Epidermal Growth Factor Receptor 2 (HER2) Negative Breast Cancer
Lead Sponsor:
Hoffmann-La Roche
Collaborating Sponsors:
Norwegian Radium Hospital
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will evaluate the effect of bevacizumab in combination with chemotherapy or endocrine therapy, as preoperative treatment, in participants with HER2 negative breast cancer. Participants will...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed, HER2-negative, men or pre- or post-menopausal women with primary operable adenocarcinoma of the breast, greater than or equal to (\>=) 2.5 centimeters (cm) in size
- Eastern Cooperative Oncology Group (ECOG)/world health organization (WHO) performance status less than or equal to (\</=) 2
- Normal baseline cardiac function (Left Ventricular Ejection Fraction \[LVEF\])
Exclusion
- Stage IV (metastatic) disease
- Previous treatment for localized breast cancer less than (\<) 24 months from diagnosis of present breast cancer
- Other previous or current cancer except for basal cell cancer or in situ cervical cancer
- Current or recent use of aspirin (greater than \[\>\] 325 milligrams per day)
- Clinically significant cardiovascular disease
Key Trial Info
Start Date :
November 7 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 9 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00773695
Start Date
November 7 2008
End Date
November 9 2022
Last Update
January 9 2023
Active Locations (3)
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1
The Norvegian Radium Hospital Montebello; Dept of Oncology
Oslo, Norway, 0379
2
Ullevael Sykehus; Dept of Oncology
Oslo, Norway, 0407
3
St. Olavs Hospital; Kreftavdelingen
Trondheim, Norway, 7000