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| Sponsored by: |
National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00020241 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment |
| 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 Start Date: | June 2000 |
| Primary Completion Date: | January 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or cytologically confirmed stage II or III breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| United States, Maryland | |
| Center for Cancer Research | |
| Bethesda, Maryland, United States, 20892 | |
| Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support | |
| Bethesda, Maryland, United States, 20892-1182 | |
| Study Chair: | Peter F. Lebowitz, MD | National Cancer Institute (NCI) |
More Information
| Study ID Numbers: | CDR0000068096, NCI-00-C-0149 |
| Study First Received: | July 11, 2001 |
| Last Updated: | February 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00020241 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage II breast cancer stage IIIA breast cancer stage IIIB breast cancer male breast cancer |
|
Antimetabolites Anastrozole Immunologic Factors Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Letrozole Cyclophosphamide Breast Cancer, Male Selective Estrogen Receptor Modulators Hormones Docetaxel Anti-Bacterial Agents Estrogen Receptor Modulators Exemestane |
Aromatase Inhibitors Alkylating Agents Breast Diseases Estrogen Antagonists Capecitabine Estrogens Skin Diseases Antineoplastic Agents, Hormonal Citric Acid Breast Neoplasms Tamoxifen Immunosuppressive Agents Doxorubicin Breast Neoplasms, Male Citrate |
|
Antimetabolites Anastrozole Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Hormone Antagonists Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Bone Density Conservation Agents Cyclophosphamide Selective Estrogen Receptor Modulators Antibiotics, Antineoplastic Docetaxel Estrogen Receptor Modulators |
Neoplasms by Site Therapeutic Uses Exemestane Aromatase Inhibitors Alkylating Agents Breast Diseases Estrogen Antagonists Capecitabine Skin Diseases Antineoplastic Agents, Hormonal Breast Neoplasms Enzyme Inhibitors Immunosuppressive Agents Tamoxifen Doxorubicin |
