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| Sponsor: | Memorial Sloan-Kettering Cancer Center |
|---|---|
| Collaborator: |
National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00436709 |
Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Biological: bevacizumab Biological: pegfilgrastim Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel albumin-stabilized nanoparticle formulation Other: flow cytometry Other: immunoenzyme technique Other: immunologic technique Other: laboratory biomarker analysis Procedure: adjuvant therapy Procedure: immunoscintigraphy |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized |
| Official Title: | A Pilot Study of Bevacizumab With Dose Dense Doxorubicin and Cyclophosphamide (AC) Followed by Dose Dense Nanoparticle Albumin Bound Paclitaxel for the Treatment of Early Stage Breast Cancer |
| Estimated Enrollment: | 75 |
| Study Start Date: | July 2006 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a nonrandomized, pilot, multicenter study.
Patients receive doxorubicin hydrochloride IV, cyclophophamide IV, and bevacizumab IV over 30-90 minutes on day 1 and pegfilgrastim subcutaneously (SC) on day 2. Treatment repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on day 1 and pegfilgrastim SC on day 2. Treatment with paclitaxel albumin-stabilized nanoparticle formulation and pegfilgrastim repeats every 2 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising bevacizumab IV over 30-90 minutes on day 1. Treatment with maintenance therapy repeats every 3 weeks for 12 courses in the absence of disease progression or unacceptable toxicity.
Blood samples are collected at baseline and periodically during study treatment. Samples are analyzed for circulating endothelial cells (by flow cytomery [FC]), circulating epithelial cells (by immunocytochemistry and FC), troponin I concentrations (by enzyme immunoassay or chemiluminescent microparticle immunoassay), and plasma renin activity (by radioimmunoassay).
After completion of study treatment, patients are followed every 4-6 months for 3 years, every 6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed invasive breast cancer meeting the following criteria:
Early-stage disease
Candidate for treatment with anthracycline- and taxane-based chemotherapy in the adjuvant setting
PATIENT CHARACTERISTICS:
No nonmalignant systemic disease (e.g., cardiovascular, renal, or hepatic) that would preclude study therapy, including any of the following conditions:
PRIOR CONCURRENT THERAPY:
Prior therapy for an ipsilateral or contralateral breast cancer primary allowed provided the following criteria are met:
More than 28 days since prior and no concurrent major surgery or open biopsy
More than 7 days since prior minor surgery, including fine-needle aspiration or core biopsy
Contacts and Locations| United States, New York | |
| Memorial Sloan-Kettering Cancer Center | |
| New York, New York, United States, 10021 | |
| Study Chair: | Maura N. Dickler, MD | Memorial Sloan-Kettering Cancer Center |
More Information
| Study ID Numbers: | CDR0000529855, MSKCC-06019 |
| Study First Received: | February 15, 2007 |
| Last Updated: | March 11, 2009 |
| ClinicalTrials.gov Identifier: | NCT00436709 History of Changes |
| Health Authority: | United States: Federal Government |
|
male breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer |
|
Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Bevacizumab Cyclophosphamide Antibiotics, Antineoplastic Neoplasms by Site Therapeutic Uses Growth Inhibitors Angiogenesis Modulating Agents Alkylating Agents Breast Diseases Skin Diseases Growth Substances |
Mitosis Modulators Breast Neoplasms Antimitotic Agents Angiogenesis Inhibitors Immunosuppressive Agents Pharmacologic Actions Doxorubicin Neoplasms Paclitaxel Tubulin Modulators Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Antineoplastic Agents, Phytogenic |