Chemotherapy and Bevacizumab in Treating Women With Invasive Breast Cancer
| Status: | Recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/1/2014 |
| Start Date: | June 2006 |
Dose-Dense Adjuvant Chemotherapy Plus Bevacizumab in Lymph Node Positive Breast Cancer: A Pilot Study
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.
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.
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.
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.
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
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