Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer

Johns Hopkins Medicine

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Procedure: neoadjuvant therapy; Biological: pegfilgrastim; Procedure: conventional surgery; Drug: docetaxel

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00080626

P50CA088843 (U.S. NIH Grant/Contract)

NA_00040559 (Other Identifier)

P30CA006973 (U.S. NIH Grant/Contract)

JHOC-03012301 (Other Identifier)

J0266

CDR0000346460 (Registry Identifier)

JHOC-J0266 (Other Identifier)

Details and patient eligibility

About

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.

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.

Enrollment: 19 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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19 participants in 1 patient group

Docetaxel

Experimental group

Description:

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.

Treatment:

Drug: docetaxel

Procedure: conventional surgery

Procedure: neoadjuvant therapy

Biological: pegfilgrastim