Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer

Study Overview
=================
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.

Official Title
-----------------
A Pilot Study Assessing Patterns of Response or Resistance to Preoperative Dose Dense Docetaxel in Women With Newly Diagnosed Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Biological: pegfilgrastim
* Drug: docetaxel
* Procedure: conventional surgery
* Procedure: neoadjuvant therapy


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Docetaxel<br>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. | Biological: pegfilgrastim<br>* 6 mg injection on day 1 of each cycle<br>* Other names: Neulasta;Drug: docetaxel<br>* 100 mg per meter-squared, every 14 days for 4 cycles<br>* Other names: Taxotere;Procedure: conventional surgery<br>* lumpectomy or mastectomy at end of treatment<br>* Other names: definitive surgery;Procedure: neoadjuvant therapy<br>* treatment prior to definitive breast surgery<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between change in apoptosis and proliferation with response after definitive surgery |  | Definitive surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between change in fludeoxyglucose F 18 positron emission tomography uptake with response after definitive surgery |  | Definitive surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer