Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer - Full Text View

Sponsors and Collaborators:	Sidney Kimmel Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00080626

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.

Condition	Intervention	Phase
Breast Cancer	Drug: docetaxel Drug: pegfilgrastim Procedure: conventional surgery Procedure: neoadjuvant therapy	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel Pegfilgrastim

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Pilot Study Assessing Patterns of Response or Resistance to Preoperative Dose Dense Docetaxel in Women With Newly Diagnosed Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Correlation between change in apoptosis and proliferation with response after definitive surgery [ Designated as safety issue: No ]

Secondary Outcome Measures:

Correlation between change in fludeoxyglucose F 18 positron emission tomagraphy uptake with response after definitive surgery [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	July 2003

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00080626

Locations

United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410

Sponsors and Collaborators

Sidney Kimmel Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Vered Stearns, MD

Sidney Kimmel Comprehensive Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000346460, JHOC-J0266, JHOC-03012301
Study First Received:	April 7, 2004
Last Updated:	July 23, 2008
ClinicalTrials.gov Identifier:	NCT00080626
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer
stage IIIA breast cancer

stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009