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Home > "P" Clinical Trials Conditions > Primary Chemotherapy with Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer  Primary Chemotherapy with Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer
Primary Chemotherapy with Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer
For Condition: Breast Cancer,Breast Neoplasm
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: This study will assess the usefulness of a technique called cDNA microarray-an examination of a wide array of genes to identify disease-associated patterns-for measuring tumor response to chemotherapy in breast cancer patients. The study will look for "markers" that can help select the most effective type of chemotherapy. It will also evaluate the safety and effectiveness of a new drug combination of capecitabine and docetaxel. Patients age 18 years and older with stage II or III breast cancer whose tumor is 2 centimeters or larger may be eligible for this study. Those enrolled will be treated with surgery, standard chemotherapy using doxorubicin (Adriamycin) and cyclophosphamide (Cytoxan), and the capecitabine and docetaxel combination. Patients will have a physical examination, mammogram and magnetic resonance imaging to evaluate their tumor before beginning treatment. They will then have four 21-day treatment cycles of docetaxel and capecitabine, as follows: docetaxel intravenously (through a vein) on day 1 and capecitabine pills (by mouth) twice a day from days 2 through 15. No drugs will be given from days 16 through 21. This regimen will be repeated four times, after which the tumor will be re-evaluated by physical examination, mammogram, and magnetic resonance imaging. Patients will then have surgery to remove the cancer-either lumpectomy with removal of the underarm lymph nodes; mastectomy and removal of the underarm lymph nodes; or modified radical mastectomy. After recovery, they will have four more cycles of chemotherapy, this time with a doxorubicin and cyclophosphamide. Both drugs will be given intravenously on day 1 of four 21-day cycles. Some patients who had a mastectomy (depending on their tumor characteristics and whether tumor cells were found in their lymph nodes) and all those who had a lumpectomy will also have radiation therapy. Patients with hormone receptor-positive tumors will also receive tamoxifen treatment for 5 years. In addition to the above procedures, all patients will have tumor biopsies (removal of a small piece of tumor tissue) before beginning treatment, on day 1 of cycle 1, before cycle 2, and at the time of surgery, and physical examinations, chest X-rays, bone scans, computerized tomography (CT) scans, electrocardiograms, MUGA (nuclear medicine test of cardiac function) or echocardiograms of heart function, mammograms and blood tests at various times during the study. Patients will be followed at NIH for 3 years after diagnosis with physical examinations, blood tests, X-rays, and CT scans. Although it is not known whether this treatment will help an individual patient's cancer, possible benefits are tumor shrinkage and decreased risk of disease recurrence. In addition, the information gained about genetic changes after chemotherapy will help determine if additional studies on the use of cDNA microarray to measure tumor response are warranted.
Details: This phase II trial in patients with stage II and stage III breast cancer will test the feasibility of using cDNA microarray as a measure of a tumor's biological response to chemotherapeutic agents by characterizing the cDNA expression patterns in breast cancer before and after primary chemotherapy. Thirty-six patients receive docetaxel/capecitabine induction chemotherapy followed by surgery and doxorubicin/cyclophosphamide adjuvant therapy (TX/AC). We will determine the response rate of TX induction therapy and the toxicities of the sequential combinations (TX/AC). We will also obtain tumor tissue for correlative biological determinations.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Stage II or III breast cancer with a tumor size of greater than 2 cm. Patients with a previous biopsy are eligible provided adequate tumor tissue remains for biopsy in this study. At least 18 years of age. Adequate hematopoietic function as defined by absolute neutrophil count greater than 1200/mm(3) and platelet count greater than 100,000/mm(3). Adequate renal function as defined by creatinine less than 1.6 mg/dL. Adequate hepatic function as defined by T. bilirubin less than 1.4 mg/dL and SGOT/SGPT less than 1.5 times the upper limit of normal and alkaline phosphatase less than 2.5 times upper limit of normal Zubrod Performance status 0-2. EXCLUSION CRITERIA: Medical or psychiatric condition that, in the opinion of the Principal Investigator, would preclude chemotherapy administration. Patients may be evaluated by psychiatry or medical subspecialties as appropriate. Pregnant or lactating women Known bleeding disorders Hypersensitivity to Tween 80 (Polysorbate) Cardiac ejection fraction below normal limits, myocardial infarction within the past 12 months, or symptomatic arrhythmia requiring medical intervention. Prior chemotherapy or hormonal therapy for breast cancer. Patients treated with hormonal chemoprevention (tamoxifen or raloxifene) will be eligible. Active malignancy diagnosed within the last 5 years. (Cervical cancer or non-melanomatous skin cancer that has been treated with curative intent will be eligible).
Total Enrollment: 36
Location and Contact Information:
National Cancer Institute (NCI)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 000149; 00-C-0149
Study Start Date: June 9, 2000
Record last reviewed: June 1, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005908
Other Breast Cancer Studies:
1. A Safety and Tolerability Study of Oral TAK-165 Administered to Subjects with Tumors Known to Express HER2
2. Establishment of Normal Breast Epithelial Cell Lines from Patients at High Risk for Breast Cancer
3. A Phase I Trial of Tamoxifen and 9-cis-Retinoic Acid in Breast Cancer Patients
4. Allogeneic (Donor) Bone Marrow Transplant to Treat Breast Cancer
5. Phase I Study of LMB-9, a Recombinant Disulfide Stabilized Immunotoxin for Advanced Carcinomas that Express Lewis Y Antigen
Related Studies:
Other Breast Cancer Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Primary Chemotherapy with Docetaxel-Capecitabine and Doxorubicin-Cyclophosphamide in Breast Cancer
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