Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer
This trial is active, not recruiting.
|Treatments||pegfilgrastim, docetaxel, conventional surgery, neoadjuvant therapy|
|Sponsor||Sidney Kimmel Comprehensive Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||July 2003|
|End date||April 2006|
|Trial size||19 participants|
|Trial identifier||NCT00080626, J0266 CDR0000346460, JHOC-03012301, JHOC-J0266, P30CA006973, P50CA088843|
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.
|Endpoint classification||efficacy study|
|Intervention model||single group assignment|
Correlation between change in apoptosis and proliferation with response after definitive surgery
time frame: Definitive surgery
Correlation between change in fludeoxyglucose F 18 positron emission tomography uptake with response after definitive surgery
time frame: Definitive surgery
Female participants at least 18 years old.
DISEASE CHARACTERISTICS: - Histologically confirmed infiltrating carcinoma of the breast - Unresected clinical stage T1c, T2, T3, or T4 lesion, any N - Newly diagnosed disease - Diagnostic mammogram and an ultrasound of the affected breast within 3 months before study entry - Mammogram of the contralateral breast within 6 months before study entry - Clinically measurable disease - Hormone receptor status: - Immunohistochemical staining for estrogen and progesterone and HER2/neu receptors must be obtained on initial diagnostic material PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - ECOG 0-2 Life expectancy - Not specified Hematopoietic - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 - Hemoglobin at least 8 g/dL Hepatic - Bilirubin no greater than 1.5 times normal Renal - Creatinine no greater than 1.5 times normal Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No medical condition that would put the patient at unnecessary risk of potentially serious complications during study participation PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - No prior chemotherapy for current breast cancer Endocrine therapy - At least 1 month since prior tamoxifen or raloxifene for breast cancer prevention - No prior endocrine therapy for current breast cancer Radiotherapy - No prior radiotherapy for current breast cancer Surgery - Not specified
|Official title||A Pilot Study Assessing Patterns of Response or Resistance to Preoperative Dose Dense Docetaxel in Women With Newly Diagnosed Breast Cancer|
|Principal investigator||Vered Stearns, MD|
|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.|
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