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Dose-Dense Adjuvant Chemotherapy Plus Bevacizumab in Lymph Node Positive Breast Cancer: A Pilot Study

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Dose-Dense Adjuvant Chemotherapy Plus Bevacizumab in Lymph Node Positive Breast Cancer: A Pilot Study



- 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.


- Estimate the 2-year and 5-year disease-free survival of patients treated with this

- 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


- 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


- 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


- 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

- No concurrent major surgery

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Incidence of treatment failure

Safety Issue:


Principal Investigator

Linnea Chap, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Premiere Oncology



Study ID:




Start Date:

June 2006

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • Breast Neoplasms



Premiere Oncology Santa Monica, California  90404