Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer

NCT ID: NCT00080626

Last Updated: 2019-03-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-11
• Study Completion Date: 2006-05-01

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Docetaxel

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.

Group Type: EXPERIMENTAL

pegfilgrastim

Intervention Type: BIOLOGICAL

6 mg injection on day 1 of each cycle

docetaxel

Intervention Type: DRUG

100 mg per meter-squared, every 14 days for 4 cycles

conventional surgery

Intervention Type: PROCEDURE

lumpectomy or mastectomy at end of treatment

neoadjuvant therapy

Intervention Type: PROCEDURE

treatment prior to definitive breast surgery

Interventions

pegfilgrastim

6 mg injection on day 1 of each cycle

Intervention Type: BIOLOGICAL

docetaxel

100 mg per meter-squared, every 14 days for 4 cycles

Intervention Type: DRUG

conventional surgery

lumpectomy or mastectomy at end of treatment

Intervention Type: PROCEDURE

neoadjuvant therapy

treatment prior to definitive breast surgery

Intervention Type: PROCEDURE

Other Intervention Names

Neulasta; Taxotere; definitive surgery

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vered Stearns, MD

Role: PRINCIPAL_INVESTIGATOR

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, United States

Countries

United States

Other Identifiers

P50CA088843

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P30CA006973

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NA_00040559

Identifier Type: OTHER

Identifier Source: secondary_id

JHOC-03012301

Identifier Type: OTHER

Identifier Source: secondary_id

JHOC-J0266

Identifier Type: OTHER

Identifier Source: secondary_id

CDR0000346460

Identifier Type: REGISTRY

Identifier Source: secondary_id

J0266

Identifier Type: -

Identifier Source: org_study_id