Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Neoadjuvant Docetaxel in Treating Women With Newly Diagnosed Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Treatment Closed 18 and over NCI JHOC-J0266 JHOC-03012301, NCT00080626

Special Category: SPORE trial

Objectives

Primary

1. 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

1. Correlate baseline and change in fludeoxyglucose F 18 positron emission tomography uptake with clinical and pathological response in patients treated with this regimen.
2. Correlate baseline and change in gene expression profiles with clinical and pathological response in patients treated with this regimen.
3. Correlate baseline and change in tumor and serum proteomic patterns with clinical and pathological response in patients treated with this regimen.

Entry 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

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

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/mm³
• Platelet count at least 100,000/mm³
• 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

Expected Enrollment

A total of 40 patients will be accrued for this study.

Outcomes

Correlation between change in apoptosis and proliferation with response after definitive surgery

Correlation between change in fludeoxyglucose F 18 positron emission tomagraphy uptake with response after definitive surgery

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.

Trial Contact Information

Trial Lead Organizations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Vered Stearns, MD, Principal investigator		Ph: 443-287-6489

Registry Information
Official Title		A Pilot Study Assessing Patterns of Response or Resistance to Preoperative Dose Dense Docetaxel in Women with Newly Diagnosed Breast Cancer
Trial Start Date		2003-07-01
Registered in ClinicalTrials.gov		NCT00080626
Date Submitted to PDQ		2003-11-14
Information Last Verified		2006-05-04
NCI Grant/Contract Number		CA88843, CA06973

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