Breast Cancer Clinical Trial

Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer

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.

View Full Description

Full 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.

View Eligibility 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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

19

Study ID:

NCT00080626

Recruitment Status:

Terminated

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Check Your Eligibility

Let’s see if you might be eligible for this study.

What is your age and gender ?

Submit

There is 1 Location for this study

See Locations Near You

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

19

Study ID:

NCT00080626

Recruitment Status:

Terminated

Sponsor:


Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

How clear is this clinincal trial information?

×

Introducing, the Journey Bar

Use this bar to access information about the steps in your cancer journey.

Please confirm you are a US based health care provider:

Yes, I am a health care Provider No, I am not a health care provider