Dose-Dense Adjuvant Chemotherapy Plus Bevacizumab in Lymph Node Positive Breast Cancer: A Pilot Study
18 Years
N/A
Female
Breast Cancer
Trial Information
Dose-Dense Adjuvant Chemotherapy Plus Bevacizumab in Lymph Node Positive Breast Cancer: A Pilot Study
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.
Inclusion 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
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of treatment failure
Safety Issue:
No
Principal Investigator
Linnea Chap, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Premiere Oncology
Authority:
Unspecified
Study ID:
CDR0000495777
NCT ID:
NCT00372866
Start Date:
June 2006
Completion Date:
Related Keywords:
- Breast Cancer
- stage II breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Premiere Oncology | Santa Monica, California 90404 |
