Breast Cancer Clinical Trial
Official title:
Phase II Trial of Docetaxel and Carboplatin Administered Every Two Weeks as Induction Therapy for Stage II or III Breast Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different
ways to stop the growth of tumor cells, either by killing the cells or by stopping them from
dividing. Colony-stimulating factors, such as pegfilgrastim, may increase the number of
immune cells found in bone marrow or peripheral blood and may help the immune system recover
from the side effects of chemotherapy. Giving docetaxel and carboplatin together with
pegfilgrastim before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well giving docetaxel and carboplatin together
with pegfilgrastim works in treating patients who are undergoing surgery for stage II or
stage III breast cancer.
OBJECTIVES:
Primary
- Determine the pathological complete response rate in patients with stage II or III
breast cancer treated with neoadjuvant docetaxel, carboplatin, and pegfilgrastim.
Secondary
- Determine the toxicity profile of this regimen in these patients.
- Determine the rate of breast-conserving surgery in patients treated with this regimen.
- Determine the clinical response rate in patients treated with this regimen.
- Determine the feasibility of drug administration, in terms of the percent of planned
dose actually administered per course, in patients treated with this regimen.
- Determine the proportion of patients with negative pathologic lymph node status after
treatment with this regimen.
- Determine the proportion of patients with residual ductal carcinoma in situ after
treatment with this regimen.
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour and carboplatin IV over 30 minutes on day 1.
Patients also receive pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days
for up to 4 courses in the absence of disease progression or unacceptable toxicity.
No more than 6 weeks after completion of chemotherapy, patients undergo definitive surgery.
After completion of study therapy, patients are followed every 6 months until disease
progression and then annually for up to 5 years. Patients who do not complete all 4 courses
of chemotherapy or do not undergo surgery are followed every 6 months for up to 5 years.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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