Expired Study
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Baltimore, Maryland 21231


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT00080626


Primary Contact:

Principal Investigator
Vered Stearns, MD
Sidney Kimmel Comprehensive Cancer Center


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21231
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: December 15, 2017

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