Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00080626
Study type	Interventional
Source	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact
Status	Terminated
Phase	Phase 2
Start date	August 11, 2003
Completion date	May 1, 2006

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.