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A Phase II Neoadjuvant Trial of Sequential Doxorubicin and Docetaxel for the Treatment of Stage III Breast Cancer Measuring STAT Activation as a Predictor of Response to Therapy


Phase 2
18 Years
70 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

A Phase II Neoadjuvant Trial of Sequential Doxorubicin and Docetaxel for the Treatment of Stage III Breast Cancer Measuring STAT Activation as a Predictor of Response to Therapy


OBJECTIVES:

- Evaluate the clinical and pathological response rate of sequential doxorubicin and
docetaxel chemotherapy in the neoadjuvant treatment of women with stage III breast
cancer.

- Measure signal transducer and activator of transcription (STAT) activation before and
after this neoadjuvant chemotherapy regimen in this patient population.

- Correlate response to chemotherapy with STAT activation before and after this
neoadjuvant chemotherapy regimen in these patients.

- Determine how other potential predictors of response correlate with STAT activation by
measuring Bcl-2, Bcl-xL, Bax protein levels, tyrosine kinase levels, growth rate of the
tumor, and apoptotic index before and after this neoadjuvant chemotherapy regimen in
these patients.

- Correlate response to chemotherapy with levels of STAT activation in association with
the presence of Bcl-2 proteins and tyrosine kinases, growth rate of the tumor, and
apoptotic index in these patients.

- Evaluate the toxicity of this neoadjuvant chemotherapy regimen given in a dose-dense
fashion in these patients.

OUTLINE: Patients receive doxorubicin IV on day 1 every 2 weeks for 3 courses. After 3 weeks
of rest, patients receive docetaxel IV over 1 hour on day 1 every 2 weeks for 3 courses.
Filgrastim (G-CSF) is administered subcutaneously on days 3-10 of each doxorubicin and
docetaxel course. Within 6 weeks of completion of neoadjuvant chemotherapy, patients undergo
surgery with mastectomy or lumpectomy and axillary lymph node dissection.

PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 5 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or pathologically confirmed stage III breast cancer

- Clinical evidence of primary invasive breast tumor greater than 5 cm in
dimension (T3) and no evidence of metastatic disease clinically or by staging
studies including computed tomography (CT) scan of the chest, abdomen, and
pelvis, and a bone scan

- Inflammatory breast carcinoma defined as diffuse brawny induration of the skin of the
breast with an erysipeloid edge due to embolization of the dermal lymphatics and
pathologic evidence of dermal lymphatic invasion

- No bilateral breast cancer unless synchronous

- Hormone receptor status:

- Not specified

PATIENT CHARACTERISTICS:

Age:

- 18 to 70

Sex:

- Female

Menopausal status:

- Not specified

Performance status:

- Eastern Cooperative Oncology Group (ECOG) 0-1

Life expectancy:

- Not specified

Hematopoietic:

- WBC at least 3,000/mm^3

- Absolute neutrophil count at least 1,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin less than 2.0 mg/dL

- SGOT/SGPT less than 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 4 times ULN provided SGOT/SGPT no greater than
ULN

Renal:

- Creatinine no greater than 1.5 mg/dL

Cardiovascular:

- If prior cardiac event or ischemia on electrocardiogram, must be cleared by
cardiologist

- LVEF at least 50% by resting MUGA

- No severe cardiac dysfunction

- No prior or concurrent angina pectoris, congestive heart failure, or major
ventricular arrhythmias

- No uncontrolled essential hypertension

Other:

- Not pregnant or nursing

- Fertile patients must use effective nonhormonal barrier contraception

- No other prior malignancy within the past 5 years except adequately treated basal
cell or squamous cell skin cancer, carcinoma in situ of the cervix, or intraductal or
lobular carcinoma in situ of the breast

- No other serious medical or psychiatric illness that would preclude study consent or
treatment

- No prior severe and intolerable reactions to filgrastim (G-CSF)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior radiotherapy to the breast

Surgery:

- Not specified

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Pathological Response Rate

Outcome Description:

Evaluate the pathological response rate of sequential doxorubicin and docetaxel chemotherapy in the neoadjuvant treatment of women with stage III breast cancer. Pathologic response is classified as either complete pathologic response or partial pathologic response based on the size of residual tumor after treatment (complete pathologic response if 0 cm, partial pathologic response if >0 cm).

Outcome Time Frame:

7 years

Safety Issue:

No

Principal Investigator

Susan Minton, D.O.

Investigator Role:

Principal Investigator

Investigator Affiliation:

H. Lee Moffitt Cancer Center and Research Institute

Authority:

United States: Food and Drug Administration

Study ID:

MCC-11971

NCT ID:

NCT00005800

Start Date:

April 1999

Completion Date:

May 2012

Related Keywords:

  • Breast Cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • inflammatory breast cancer
  • Breast Neoplasms

Name

Location

H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612