Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments pegfilgrastim, docetaxel, conventional surgery, neoadjuvant therapy
Phase phase 2
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

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
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
pegfilgrastim Neulasta
6 mg injection on day 1 of each cycle
docetaxel Taxotere
100 mg per meter-squared, every 14 days for 4 cycles
conventional surgery definitive surgery
lumpectomy or mastectomy at end of treatment
neoadjuvant therapy
treatment prior to definitive breast surgery

Primary Outcomes

Measure
Correlation between change in apoptosis and proliferation with response after definitive surgery
time frame: Definitive surgery

Secondary Outcomes

Measure
Correlation between change in fludeoxyglucose F 18 positron emission tomography uptake with response after definitive surgery
time frame: Definitive surgery

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center.