Status:
COMPLETED
Bevacizumab Given With Either Anastrozole or Fulvestrant With Trastuzumab for Postmenopausal Metastatic Breast Cancer
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Genentech, Inc.
AstraZeneca
Conditions:
Breast Cancer
Breast Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a phase II trial combining bevacizumab with either fulvestrant or anastrozole with trastuzumab in the treatment of metastatic breast cancer in postmenopausal women. It is hoped that these comb...
Detailed Description
Regimen A: Bevacizumab/anastrozole (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks \[patients who are also receiving trastuzumab have the option to receive their bevacizumab...
Eligibility Criteria
Inclusion
- Postmenopausal breast cancer (adenocarcinoma) estrogen (ER)and/or progesterone (PR) receptor positive that is locally advanced or locally recurrent and not able to be surgically removed OR with measurable and/or disease that is able to be assessed including isolated bone metastasis
- Female patients 18 years or older
- Documentation of ER+ and/or PR+
- No prior chemotherapy or hormone therapy for metastatic breast cancer or inoperable breast cancer that is locally recurrent or locally advanced
- Measurable or evaluable disease
- Radiation therapy to painful bone lesions or impending fractures is allowed as long as there is measurable or evaluable disease outside the radiated area.
- Must have adequate bone marrow, renal and liver function
- Patients receiving prior treatment with an anthracycline based chemotherapy must have a normal left ventricle ejection fraction
Exclusion
- No metastatic disease to the Central Nervous System
- No history of myocardial infarction (MI), stroke or transient ischemic attacks in the last 6 months
- No symptoms of peripheral vascular disease
- No history of abdominal fistula, gastrointestinal perforation or intrabdominal abscess in the past 6 months
- No known hypersensitivity to phosphate, trehalose or polysorbate
- No serious non-healing wound, ulcer or bone fracture
- No uncontrolled high blood pressure or history of hypertensive crisis
- No New York Hear Association class II congestive heart failure
- No extensive cancer involvement of the liver or lungs
- No history of significant psychiatric disorders
- No significant vascular disease
- There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.
Key Trial Info
Start Date :
November 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
79 Patients enrolled
Trial Details
Trial ID
NCT00405938
Start Date
November 1 2006
End Date
June 1 2011
Last Update
November 18 2021
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
2
Integrated Community Oncology Network
Jacksonville, Florida, United States, 32256
3
Florida Hospital Cancer Institute
Orlando, Florida, United States, 32804
4
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501