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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

Definitive surgery

Safety Issue:

No

Principal Investigator

Vered Stearns, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sidney Kimmel Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

J0266 CDR0000346460

NCT ID:

NCT00080626

Start Date:

July 2003

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
  • stage IV breast cancer
  • Breast Neoplasms

Name

Location

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410