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Combination Chemotherapy and Surgery in Treating Patients With Stage II or Stage III Breast Cancer
This study has been completed.
Study NCT00020241   Information provided by National Cancer Institute (NCI)
First Received: July 11, 2001   Last Updated: February 14, 2009   History of Changes

July 11, 2001
February 14, 2009
June 2000
January 2008   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00020241 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy and Surgery in Treating Patients With Stage II or Stage III Breast Cancer
A Pilot Trial of Sequential Primary (Neoadjuvant) Combination Chemotherapy With Docetaxel/Capecitabine (TX) and Doxorubicin/Cyclophosphamide (AC) in Primary Breast Cancer With Evaluation of Chemotherapy Effects on Gene Expression

RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and surgery in treating patients who have stage II or stage III breast cancer.

OBJECTIVES:

  • Evaluate the feasibility of using cDNA microarray as a measure of a tumor's biological response to neoadjuvant docetaxel and capecitabine followed by surgery and adjuvant doxorubicin and cyclophosphamide by characterizing the cDNA expression patterns before and after chemotherapy in patients with stage II or III breast cancer.
  • Determine the toxic effects of this regimen in these patients.
  • Determine the clinical and pathologic response rate of patients treated with this regimen.
  • Determine the feasibility of obtaining clinical material for exploratory studies using cDNA microarray and proteomic approaches in these patients.

OUTLINE: Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice daily on days 2-15 every 21 days for 4 courses. After surgery, patients receive doxorubicin IV and cyclophosphamide IV over 30 minutes on day 1 every 21 days for 4 courses. Patients who undergo lumpectomy and axillary lymph node dissection receive standard radiotherapy after the completion of chemotherapy. Patients who undergo a modified radical mastectomy may receive chest wall radiation. Patients with estrogen or progesterone receptor-positive disease receive oral tamoxifen daily for 5 years. Post-menopausal patients with a contraindication to tamoxifen may receive anastrozole daily for 5 years. After 2-5 years of tamoxifen therapy, patients may recieve letrozole, exemestane, or anastrazole.

Tumor tissue is collected at baseline, day 2 of course 1 of neoadjuvant chemotherapy, prior to course 2 of neoadjuvant chemotherapy, and at surgery. These samples are subjected to reverse transcriptase polymerase chain reaction, cDNA microarray analysis, and proteomic expression analysis using surface-enhanced laser desorption/ionization-time of flight mass spectrometry in order to evaluate gene expression ratios before and after chemotherapy.

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 18 months.

Phase II
Interventional
Treatment
Breast Cancer
  • Drug: anastrozole
  • Drug: capecitabine
  • Drug: cyclophosphamide
  • Drug: docetaxel
  • Drug: doxorubicin hydrochloride
  • Drug: exemestane
  • Drug: letrozole
  • Drug: tamoxifen citrate
  • Genetic: microarray analysis
  • Genetic: proteomic profiling
  • Genetic: reverse transcriptase-polymerase chain reaction
  • Other: laboratory biomarker analysis
  • Other: surface-enhanced laser desorption/ionization-time of flight mass spectrometry
  • Procedure: conventional surgery
  • Radiation: radiation therapy
 
Lebowitz PF, Eng-Wong J, Swain SM, Berman A, Merino MJ, Chow CK, Venzon D, Zia F, Danforth D, Liu E, Zujewski J. A phase II trial of neoadjuvant docetaxel and capecitabine for locally advanced breast cancer. Clin Cancer Res. 2004 Oct 15;10(20):6764-9.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
 
 
January 2008   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage II or III breast cancer

    • Tumor size > 2 cm
  • Prior biopsy allowed if adequate tumor tissue remains for second biopsy
  • Hormone receptor status:

    • Receptor status known

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count > 1,200/mm^3
  • Platelet count > 100,000/mm^3
  • No known bleeding disorders

Hepatic:

  • Bilirubin < 1.4 mg/dL
  • SGOT/SGPT < 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase < 2.5 times ULN

Renal:

  • Creatinine < 1.6 mg/dL
  • Creatinine clearance > 50 mL/min

Cardiovascular:

  • Cardiac ejection fraction normal
  • No myocardial infarction within the past year
  • No symptomatic arrhythmia requiring treatment

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective nonhormonal contraception
  • No known hypersensitivity to polysorbate
  • No medical or psychiatric condition that would preclude study compliance
  • No other prior malignancy in the past 5 years except curatively treated cervical cancer or nonmelanomatous skin cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • No prior chemotherapy for breast cancer

Endocrine therapy:

  • No prior hormonal therapy for breast cancer
  • Prior tamoxifen or raloxifene allowed if administered to decrease the risk of breast cancer

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Other:

  • No other concurrent antitumor therapy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00020241
 
CDR0000068096, NCI-00-C-0149
National Cancer Institute (NCI)
 
Study Chair: Peter F. Lebowitz, MD National Cancer Institute (NCI)
National Cancer Institute (NCI)
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP