Docetaxel, Carboplatin, and Pegfilgrastim in Treating Patients Who Are Undergoing Surgery for Stage II or Stage III Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT00107510
- Lead Sponsor
- Alliance for Clinical Trials in Oncology
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description docetaxel + carboplatin + pegfilgrastim + surgery pegfilgrastim 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. docetaxel + carboplatin + pegfilgrastim + surgery carboplatin 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. docetaxel + carboplatin + pegfilgrastim + surgery conventional surgery 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. docetaxel + carboplatin + pegfilgrastim + surgery docetaxel 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.
- Primary Outcome Measures
Name Time Method Pathological complete response rate by histologic evaluation at definitive surgery Up to 5.5 years
- Secondary Outcome Measures
Name Time Method Toxicity profile by CTCAE v3.0 at baseline and each subsequent evaluation Up to 5.5 years Rate of breast conserving surgery at definitive surgery after neoadjuvant chemotherapy Up to 5.5 years Clinical response rate by clinical examination prior to definitive surgery Up to 5.5 years
Related Research Topics
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Trial Locations
- Locations (117)
Mayo Clinic Scottsdale
🇺🇸Scottsdale, Arizona, United States
Mayo Clinic - Jacksonville
🇺🇸Jacksonville, Florida, United States
Rush-Copley Cancer Care Center
🇺🇸Aurora, Illinois, United States
St. Joseph Medical Center
🇺🇸Bloomington, Illinois, United States
Graham Hospital
🇺🇸Canton, Illinois, United States
Memorial Hospital
🇺🇸Carthage, Illinois, United States
Eureka Community Hospital
🇺🇸Eureka, Illinois, United States
Galesburg Clinic
🇺🇸Galesburg, Illinois, United States
Galesburg Cottage Hospital
🇺🇸Galesburg, Illinois, United States
Mason District Hospital
🇺🇸Havana, Illinois, United States
Scroll for more (107 remaining)Mayo Clinic Scottsdale🇺🇸Scottsdale, Arizona, United States