Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00080626
• Other study ID #: J0266
• Secondary ID: P50CA088843P30CA
• Status: Terminated
• Phase: Phase 2
• Start date: August 11, 2003
• Est. completion date: May 1, 2006

Study information

• Verified date: March 2019
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: May 1, 2006
• Est. primary completion date: May 1, 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Biological:
• pegfilgrastim
6 mg injection on day 1 of each cycle

Drug:
• docetaxel
100 mg per meter-squared, every 14 days for 4 cycles

Procedure:
• conventional surgery
lumpectomy or mastectomy at end of treatment
• neoadjuvant therapy
treatment prior to definitive breast surgery

Locations

Country	Name	City	State
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between change in apoptosis and proliferation with response after definitive surgery		Definitive surgery
Secondary	Correlation between change in fludeoxyglucose F 18 positron emission tomography uptake with response after definitive surgery		Definitive surgery