Status:
COMPLETED
Carboplatin+Nab-paclitaxel, Plus Trastuzumab (HER2+) or Bevacizumab (HER2-) in the Neoadjuvant Setting
Lead Sponsor:
University of California, Irvine
Collaborating Sponsors:
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Conditions:
Breast Cancer
HER2-negative Breast Cancer
Eligibility:
FEMALE
21-90 years
Phase:
PHASE2
Brief Summary
This phase II is studying the side effects and how well carboplatin and paclitaxel albumin-stabilized nanoparticle formulation when together with bevacizumab or trastuzumab before surgery works in tre...
Detailed Description
PRIMARY OBJECTIVES: I. To estimate 2 year progression-free survival in patients with breast cancer more than 1 cm and/or lymph node positive breast cancer treated with weekly Carboplatin/Nab-Paclitax...
Eligibility Criteria
Inclusion
- Patients must be women with a histologically confirmed diagnosis of breast cancer that is more than 1 cm and or lymph node positive
- Physical examination, and scans needed for tumor assessment must be performed within 90 days prior to registration
- Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible
- Serum creatinine within normal limits within 90 days prior to registration
- Bilirubin within normal limits within 90 days prior to registration
- Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) =\< 2 x the institutional upper limit of normal within 90 days prior to registration
- Absolute neutrophil count (ANC) of \>= 1,500/microliters within 90 days prior to registration
- Platelet count of \>= 100,000/microliters within 90 days prior to registration
- Patients must have a performance status of 0-2 by Zubrod criteria
- Pregnant or nursing women may not participate; women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method; pregnancy test required for women of childbearing potential
- In calculating days of tests and measurements, the day a test or measurement is done is considered day 0; therefore, if a test is done on a Monday, the Monday four weeks later would be considered day 28; this allows for efficient patient scheduling without exceeding the guidelines; if day 28 or 42 falls on a weekend or holiday, the limit may be extended to the next working day
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
Exclusion
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
127 Patients enrolled
Trial Details
Trial ID
NCT00618657
Start Date
February 1 2008
End Date
July 1 2021
Last Update
February 28 2024
Active Locations (1)
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1
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868