|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 11, 2001 | ||||
| Last Updated Date | February 14, 2009 | ||||
| Start Date ICMJE | June 2000 | ||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00020241 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Combination Chemotherapy and Surgery in Treating Patients With Stage II or Stage III Breast Cancer | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | 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. |
||||
| Detailed Description | 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. |
||||
| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment | ||||
| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE |
|
||||
| Study Arms / Comparison Groups | |||||
| Publications * | 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. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | |||||
| Completion Date | |||||
| Primary Completion Date | January 2008 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
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:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00020241 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000068096, NCI-00-C-0149 | ||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
|
||||
| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2006 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||