Status:
UNKNOWN
Bevacizumab, Doxorubicin, and Cyclophosphamide Followed By Paclitaxel Albumin-Stabilized Nanoparticle Formulation and Bevacizumab in Treating Patients Who Have Undergone Surgery for Early-Stage Breast Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or...
Detailed Description
OBJECTIVES: Primary * Determine the cardiac safety of adjuvant concurrent bevacizumab and dose-dense doxorubicin hydrochloride and cyclophosphamide followed by dose-dense paclitaxel albumin-stabiliz...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed invasive breast cancer meeting the following criteria:
- Early-stage disease
- No stage IV disease
- More than one synchronous primary breast tumor
- Lymph node positive OR high-risk lymph node negative
- Candidate for treatment with anthracycline- and taxane-based chemotherapy in the adjuvant setting
- Must begin therapy within 84 days after the final required surgical procedure
- HER2/neu-negative breast cancer, defined as an immunohistochemistry (IHC) score of 0, 1+ or 2+ and fluorescent in situ hybridization (FISH) not amplified
- No CNS disease (e.g., primary brain tumor or brain metastasis)
- Hormone receptor status known
- PATIENT CHARACTERISTICS:
- Male or female
- Pre- or post-menopausal
- ECOG performance status 0-1
- Absolute neutrophil count ≥ 1,000/mm\^3
- Platelet count ≥ 100,000/mm\^3
- Bilirubin normal
- AST or ALT ≤ 2.5 times upper limit of normal
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Urine protein:creatinine ratio ≤ 1.0
- PT and PTT normal
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 6 months after completion of study therapy
- LVEF normal by MUGA scan at baseline
- No significant bleeding within the past 6 months
- No uncontrolled underlying bleeding diathesis
- No nonmalignant systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude study therapy, including any of the following conditions:
- Blood pressure \> 150/100 mm Hg
- Unstable angina
- New York Heart Association class II -IV congestive heart failure
- Myocardial infarction or stroke within the past 12 months
- Clinically significant peripheral vascular disease
- No seizures not controlled with standard medical therapy
- No history of stroke
- No known allergy or hypersensitivity to study drugs (prior hypersensitivity to paclitaxel allowed)
- No significant traumatic injury within the past 28 days
- No serious nonhealing wound, ulcer, or bone fracture
- No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
- No active gastroduodenal ulcer
- No uncontrolled intercurrent illness, including psychiatric illness or social situation that would limit compliance with study requirements
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior therapy for an ipsilateral or contralateral breast cancer primary allowed provided the following criteria are met:
- No prior anthracycline therapy
- Prior hormonal therapy for this previous breast cancer is allowed, but must be stopped during study therapy
- At least 1 year since prior taxane therapy
- More than 28 days since prior and no concurrent major surgery or open biopsy
- Anticipated reconstructive surgery (e.g., tissue expander exchange) is allowed during the course of the study (bevacizumab will be held during that time as per protocol guidelines)
- More than 7 days since prior minor surgery, including fine-needle aspiration or core biopsy
- At least 24 hours since prior indwelling catheter placement
- No prior bevacizumab or other KDR inhibitors (e.g., VEGF Trap, semaxanib, SU6668, vandetanib, vatalanib, AEE788, or IMC-1CII)
- No concurrent full-dose anticoagulation therapy
- No concurrent hormonal therapy as chemoprevention
- Concurrent participation in adjuvant hormone therapy or correlative or companion (e.g., bisphosphonate clinic) studies allowed
- No other concurrent anticancer therapy
Exclusion
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT00436709
Start Date
July 1 2006
Last Update
January 6 2014
Active Locations (1)
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1
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021