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Chemotherapy and Bevacizumab in Treating Women With Invasive Breast Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2007 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00372866
First received: September 6, 2006
Last updated: February 6, 2009
Last verified: April 2007
History of Changes
  Purpose

RATIONALE: Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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 tumor cells by blocking blood flow to the tumor. Giving chemotherapy together with bevacizumab after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This clinical trial is studying how well giving chemotherapy together with bevacizumab works in treating women with invasive breast cancer.


Condition Intervention
Breast Cancer
 Biological: bevacizumab
Biological: filgrastim
Biological: pegfilgrastim
Drug: cyclophosphamide
Drug: doxorubicin hydrochloride
Drug: paclitaxel
Procedure: adjuvant therapy

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: Dose-Dense Adjuvant Chemotherapy Plus Bevacizumab in Lymph Node Positive Breast Cancer: A Pilot Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Incidence of treatment failure [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Toxicity [ Designated as safety issue: Yes ]
  • Adverse events [ Designated as safety issue: Yes ]
  • Disease-free survival at 2 and 5 years [ Designated as safety issue: No ]
  • Correlation of circulating tumor cell and circulating endothelial progenitor cell assay results with clinical outcomes [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2006
Detailed Description:

OBJECTIVES:

Primary

  • Determine the feasibility and toxicity of dose-dense adjuvant chemotherapy and bevacizumab followed by single-agent bevacizumab in women with lymph-node positive, invasive breast cancer.

Secondary

  • Estimate the 2-year and 5-year disease-free survival of patients treated with this regimen.
  • Describe the detection rate of circulating tumor cells and circulating endothelial cells before initiating adjuvant treatment in these patients.

OUTLINE: This is an open-label, pilot study.

  • Dose-dense chemotherapy (courses 1-8): Patients receive doxorubicin hydrochloride IV and cyclophosphamide IV on day 1. Treatment repeats every 2 weeks for 4 courses. Patients then receive paclitaxel IV over 3 hours on day 1. Treatment repeats every 2 weeks for 4 courses.
  • Bevacizumab (courses 1-20): Beginning with course 1 of chemotherapy, patients also receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 2 weeks for 8 courses. Patients then receive bevacizumab alone every 3 weeks for 12 courses.

Patients also receive filgrastim (G-CSF) daily on days 3-10 OR pegfilgrastim once on day 2 of each chemotherapy course.

After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed invasive breast cancer

  • Stage IIA-IIIB disease

    • Lymph node-positive disease

  • Must have undergone local surgical therapy (modified radical mastectomy or breast-conserving surgery) within the past 28-42 days

    • Negative tumor margins for invasive cancer
  • Bilateral synchronous breast cancer allowed if other criteria are met
  • No inflammatory breast cancer
  • No HER2/neu-positive tumors
  • No evidence of distant metastasis
  • No CNS or brain metastases

  • Hormone receptor status:

    • Any status

PATIENT CHARACTERISTICS:

  • Female
  • Menopausal status not specified
  • Performance status 0-1
  • Absolute neutrophil count ≥ 1,200/mm³
  • Platelet count > 100,000/mm³
  • Creatinine < 2.0 mg/dL
  • Bilirubin < 1.5 times upper limit of normal
  • LVEF normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other malignancies within the past 5 years except for carcinoma in situ of the cervix, melanoma in situ, or basal cell carcinoma of the skin
  • Blood pressure ≤ 150/100 mm Hg
  • Urine protein:creatinine ratio < 1.0
  • No unstable angina
  • No New York Heart Association class II-IV congestive heart failure
  • No myocardial infarction or stroke within the past 6 months
  • No clinically significant peripheral vascular disease
  • No evidence of bleeding diathesis or coagulopathy
  • No significant traumatic injury within the past 28 days
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • No serious, nonhealing wound, ulcer, or bone fracture

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics

  • No prior chemotherapy, hormonal therapy, or radiotherapy for treatment of the primary breast cancer

    • Tamoxifen or aromatase inhibitors allowed
  • No prior anthracyclines for any malignancy
  • More than 4 weeks since prior and no concurrent participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
  • More than 28 days since prior major surgery or open biopsy
  • More than 7 days since prior minor surgery, including fine-needle aspiration or core biopsies
  • No concurrent major surgery
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00372866

Locations
United States, California
Premiere Oncology Recruiting
Santa Monica, California, United States, 90404
Contact: Linnea Chap, MD     310-633-8400        
Sponsors and Collaborators
Premiere Oncology
Investigators
Study Chair: Linnea Chap, MD Premiere Oncology
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00372866     History of Changes
Other Study ID Numbers: CDR0000495777, PREMIERE-AVF3359S, PREMIERE-WIRB-20060904, PREMIERE-WIRB-1079513
Study First Received: September 6, 2006
Last Updated: February 6, 2009
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Adjuvants, Immunologic
Lenograstim
Cyclophosphamide
Bevacizumab
Doxorubicin
Paclitaxel
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Immunosuppressive Agents
 Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antineoplastic Agents, Phytogenic
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances

ClinicalTrials.gov processed this record on May 16, 2013