Docetaxel, Carboplatin, and Pegfilgrastim in Treating Patients Who Are Undergoing Surgery for Stage II or Stage 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.
Procedure: conventional surgery
Procedure: neoadjuvant therapy
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Trial of Docetaxel and Carboplatin Administered Every Two Weeks as Induction Therapy for Stage II or III Breast Cancer|
- Pathological complete response rate by histologic evaluation at definitive surgery [ Designated as safety issue: No ]
- Toxicity profile by CTCAE v3.0 at baseline and each subsequent evaluation [ Designated as safety issue: Yes ]
- Rate of breast conserving surgery at definitive surgery after neoadjuvant chemotherapy [ Designated as safety issue: No ]
- Clinical response rate by clinical examination prior to definitive surgery [ Designated as safety issue: No ]
|Study Start Date:||August 2005|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
- Determine the pathological complete response rate in patients with stage II or III breast cancer treated with neoadjuvant docetaxel, carboplatin, and pegfilgrastim.
- 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.
PROJECTED ACCRUAL: A total of 25-58 patients will be accrued for this study within 21-23 months.
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|Study Chair:||Vivek Roy, MD, FACP||Mayo Clinic|
|Investigator:||Edith A. Perez, MD||Mayo Clinic|
|Investigator:||Robert T. Chambers, MD, FRCSC, FACS||MeritCare Wahpeton|
|Investigator:||Judith E. Hurley, MD||University of Miami Sylvester Comprehensive Cancer Center|