Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Biological: pegfilgrastimProcedure: conventional surgeryProcedure: neoadjuvant therapy
- Registration Number
- NCT00080626
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Giving a chemotherapy drug before surgery may shrink the tumor so that it can be removed.
PURPOSE: This phase II trial is studying how well neoadjuvant docetaxel works in treating women who are undergoing surgery for breast cancer.
- Detailed Description
OBJECTIVES:
Primary
* Correlate baseline and change in apoptosis and proliferation with clinical and pathological response to neoadjuvant docetaxel followed by surgery in women with newly diagnosed breast cancer.
Secondary
* Correlate baseline and change in fludeoxyglucose F 18 positron emission tomography uptake with clinical and pathological response in patients treated with this regimen.
* Correlate baseline and change in gene expression profiles with clinical and pathological response in patients treated with this regimen.
* Correlate baseline and change in tumor and serum proteomic patterns with clinical and pathological response in patients treated with this regimen.
OUTLINE: This is a pilot study.
* Neoadjuvant chemotherapy: Patients receive docetaxel IV over 1 hour on day 1 and pegfilgrastim subcutaneously (SC) on day 2. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity.
* Surgery: Within 2-4 weeks after the completion of 4 courses of docetaxel, patients undergo breast-conserving surgery or a mastectomy at the discretion of the treating surgeon. Patients may receive additional chemotherapy prior to surgery at the discretion of the treating physician.
* Adjuvant chemotherapy: Patients receive adjuvant chemotherapy at the discretion of the treating physician.
* Radiotherapy: Patients undergo radiotherapy after the completion of all chemotherapy at the discretion of the treating physician.
* Hormonal therapy: Patients with estrogen- and/or progesterone-positive tumors receive hormonal therapy after the completion of chemotherapy and all local therapies at the discretion of the treating physician.
Patients are followed every 6 months.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 19
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Docetaxel pegfilgrastim Neoadjuvant therapy with docetaxel (IV, 100 mg/m2, every 14 days with growth factor support with pegfilgrastim) for a total of 4 cycles prior to conventional surgery for breast cancer. Docetaxel conventional surgery Neoadjuvant therapy with docetaxel (IV, 100 mg/m2, every 14 days with growth factor support with pegfilgrastim) for a total of 4 cycles prior to conventional surgery for breast cancer. Docetaxel neoadjuvant therapy Neoadjuvant therapy with docetaxel (IV, 100 mg/m2, every 14 days with growth factor support with pegfilgrastim) for a total of 4 cycles prior to conventional surgery for breast cancer. Docetaxel docetaxel Neoadjuvant therapy with docetaxel (IV, 100 mg/m2, every 14 days with growth factor support with pegfilgrastim) for a total of 4 cycles prior to conventional surgery for breast cancer.
- Primary Outcome Measures
Name Time Method Correlation between change in apoptosis and proliferation with response after definitive surgery Definitive surgery
- Secondary Outcome Measures
Name Time Method Correlation between change in fludeoxyglucose F 18 positron emission tomography uptake with response after definitive surgery Definitive surgery
Trial Locations
- Locations (1)
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
🇺🇸Baltimore, Maryland, United States