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

NCT00436709 | Unknown

• 2 other identifiers: CDR0000529855MSKCC-06019
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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 carry tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with chemotherapy after surgery may kill any tumor cells that remain after surgery. PURPOSE: This clinical trial is studying the side effects and how well giving bevacizumab together with doxorubicin and cyclophosphamide followed by paclitaxel albumin-stabilized nanoparticle formulation and bevacizumab works in treating patients who have undergone surgery for early-stage breast cancer.

Conditions

Breast Cancer

Keywords

male breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer

Outcome Measures

Primary Outcomes (1)

• Safety

Secondary Outcomes (3)

• Noncardiac toxicity

• Time to tumor recurrence

• Overall survival

Interventions

bevacizumab BIOLOGICAL

pegfilgrastim BIOLOGICAL

cyclophosphamide DRUG

doxorubicin hydrochloride DRUG

paclitaxel albumin-stabilized nanoparticle formulation DRUG

flow cytometry OTHER

immunoenzyme technique OTHER

immunologic technique OTHER

laboratory biomarker analysis OTHER

adjuvant therapy PROCEDURE

immunoscintigraphy PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

Bevacizumab; pegfilgrastim; Cyclophosphamide; Doxorubicin; Taxes; Flow Cytometry; Immunoenzyme Techniques; Immunologic Techniques; Chemotherapy, Adjuvant; Radioimmunodetection

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Economics; Health Care Economics and Organizations; Cell Separation; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cytophotometry; Fluorometry; Luminescent Measurements; Photometry; Chemistry Techniques, Analytical; Investigative Techniques; Immunoassay; Immunohistochemistry; Molecular Probe Techniques; Combined Modality Therapy; Therapeutics; Drug Therapy; Radionuclide Imaging; Diagnostic Imaging; Diagnostic Techniques, Radioisotope

Study Officials

• Maura N. Dickler, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 15, 2007
• First Posted: February 19, 2007
• Study Start: July 1, 2006
• Last Updated: January 6, 2014

Record last verified: 2007-06

Locations

US (1)