Combination Chemotherapy and Surgery in Treating Patients With Stage II or Stage III Breast Cancer
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: anastrozole (Drug); capecitabine (Drug); cyclophosphamide (Drug); docetaxel (Drug); doxorubicin hydrochloride (Drug); exemestane (Drug); letrozole (Drug); tamoxifen citrate (Drug); antiestrogen therapy (Procedure); aromatase inhibition therapy (Procedure); chemotherapy (Procedure); conventional surgery (Procedure); diagnostic procedure (Procedure); gene expression profiling (Procedure); laboratory biomarker analysis (Procedure); proteomic profiling (Procedure); radiation therapy (Procedure); reverse transcriptase-polymerase chain reaction (Procedure); surface-enhanced laser desorption/ionization-time of flight mass spectrometry (Procedure)
Phase: Phase 2
Sponsored by: National Cancer Institute (NCI)
Official(s) and/or principal investigator(s):
Peter F. Lebowitz, MD, Study Chair, Affiliation: National Cancer Institute (NCI)
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.
Official title: 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
Study design: Treatment
- 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
- 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
Minimum age: 18 Years.
Maximum age: N/A.
- 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
- 18 and over
- Male or female
- Not specified
- Zubrod 0-2
- Not specified
- Absolute neutrophil count > 1,200/mm^3
- Platelet count > 100,000/mm^3
- No known bleeding disorders
- Bilirubin < 1. 4 mg/dL
- SGOT/SGPT < 1. 5 times upper limit of normal (ULN)
- Alkaline phosphatase < 2. 5 times ULN
- Creatinine < 1. 6 mg/dL
- Creatinine clearance > 50 mL/min
- Cardiac ejection fraction normal
- No myocardial infarction within the past year
- No symptomatic arrhythmia requiring treatment
- 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:
- Not specified
- No prior chemotherapy for breast cancer
- No prior hormonal therapy for breast cancer
- Prior tamoxifen or raloxifene allowed if administered to decrease the risk of breast
- Not specified
- See Disease Characteristics
- No other concurrent antitumor therapy
Locations and Contacts
Center for Cancer Research, Bethesda, Maryland 20892, United States
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support, Bethesda, Maryland 20892-1182, United States
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: June 2000
Last updated: January 30, 2008