Stage IIIA Breast Cancer Clinical Trial
Official title:
Phase II Feasibility Trial Incorporating Bevacizumab Into Dose Dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Patients With Lymph Node Positive Breast Cancer
This phase II trial is studying how well giving bevacizumab together with combination chemotherapy works in treating patients who have undergone surgery for breast cancer that has spread to the lymph nodes. 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. Drugs used in chemotherapy 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 more than one chemotherapy drug (combination chemotherapy), may be a better way to block tumor growth.
PRIMARY OBJECTIVES:
I. To determine the incidence of clinically apparent cardiac dysfunction in patients with
lymph node positive breast cancer treated with bevacizumab and dose dense
doxorubicin/cyclophosphamide followed by paclitaxel (ddAC > T).
SECONDARY OBJECTIVES:
I. To evaluate changes in LVEF during treatment. II. To evaluate non-cardiac toxicity.
OUTLINE: This is a non-randomized, multicenter study. Patients are sequentially assigned to
1 of 2 treatment arms.
Arm A: Patients receive doxorubicin IV, cyclophosphamide IV over 20-30 minutes, and
bevacizumab IV over 30-90 minutes on day 1. Patients also receive filgrastim (G-CSF)
subcutaneously (SQ) on days 2-11 or pegfilgrastim SC on day 2. Treatment repeats every 14
days for 4 courses. Patients then receive paclitaxel IV over 3 hours and bevacizumab IV over
30-90 minutes on day 1. Patients also receive G-CSF or pegfilgrastim as above. Treatment
with paclitaxel, bevacizumab, and G-CSF or pegfilgrastim repeats every 14 days for 4
courses. Patients then receive bevacizumab alone every 14 days for up to 18 courses.
Arm B: Patients receive doxorubicin, cyclophosphamide, and G-CSF or pegfilgrastim as in
group I. Patients then receive paclitaxel, bevacizumab, and G-CSF or pegfilgrastim as in
group I. Patients then receive bevacizumab alone every 14 days for up to 22 courses.
Treatment in both groups continues in the absence of disease recurrence or unacceptable
toxicity.
Patients who require radiotherapy (post-lumpectomy) or who plan radiotherapy at the
discretion of the investigator (post-mastectomy) undergo radiotherapy beginning within 6
weeks after the completion of chemotherapy.
Premenopausal patients with estrogen receptor (ER) and/or progesterone receptor (PR)
positive disease receive oral tamoxifen once daily for 5 years beginning at the time of
radiotherapy or within 6 weeks after the completion of chemotherapy. Postmenopausal patients
with ER and/or PR positive disease receive an aromatase inhibitor (e.g., anastrozole,
letrozole, or exemestane) or tamoxifen followed by an aromatase inhibitor once daily for up
to 10 years.
After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for up to 3 years from study entry.
ACCRUAL: A total of 226 patients (104 on arm A and 122 on arm B) were accrued for this
study.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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