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Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer Clinical Trials References presented on Clinical Trials Search is not intended to be a substitute for proven healthcare advice, trips or professional assistance by using a real medical. We aren't mDs. Always confer with your physician about Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer Clinical research trials and Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectualness of new does drugs. The purpose of the studies / projects is to solve specific human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to discover treatments for all sorts of conditions, such as Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer. Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer Clinical Trials and other clinical trials permit volunteers to access healthcare treatment choices before they are available to the general public. Some times the subjects recieve professional assistance for without cost, and every now and again they are compensated for their time. Sometimes there is a cost for a Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer clinical trial. Subjects often receive the most expert healthcare possible for their Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, healthcare dangers (perhaps life-jeopardising), and/or the treatment being ineffective. Trials are federally governed with stern guidelines to protect clinical trials subjects.
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Home > "T" Clinical Trials Conditions > Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer  Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer
Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Vanderbilt-Ingram Cancer Center
Synopsis: RATIONALE: Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of trastuzumab plus docetaxel in treating women who have recurrent or metastatic breast cancer.
Details: OBJECTIVES: I. Determine the objective response rate of women with HER2-neu overexpressing recurrent or metastatic breast cancer treated with trastuzumab (Herceptin) in combination with docetaxel. II. Determine the toxicity of this treatment regimen in these patients. III. Determine the duration of response to this treatment regimen in these patients. IV. Determine the time to progression in these patients after receiving this treatment regimen. V. Compare HER2-neu overexpression as determined by fluorescent in situ hybridization (FISH) versus immunohistochemistry, and correlate these findings with response to this treatment regimen in these patients. VI. Correlate HER2-neu activation by immunohistochemistry and the extracellular domain of HER2-neu by ELISA with response to this treatment regimen in these patients. PROTOCOL OUTLINE: This is a multicenter study. Patients receive docetaxel IV over 30 minutes weekly for 6 weeks plus trastuzumab (Herceptin) IV over 30-90 minutes weekly for 8 weeks. Treatment continues every 8 weeks in the absence of disease progression or unacceptable toxicity. Patients are followed monthly for 3 months, every 3 months for 9 months, and then every 6 months thereafter. PROJECTED ACCRUAL: A total of 18-34 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed recurrent or metastatic breast cancer; HER2-neu overexpressing tumor (2+ or 3+) - Measurable or evaluable disease; If bone disease only, must have lytic lesions - No carcinomatous meningitis or untreated or uncontrolled brain parenchymal disease - Prior brain parenchymal disease allowed if controlled by appropriate therapy given at least 8 weeks prior to study, and patient is asymptomatic from CNS disease - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: No concurrent biologic response modifiers - Chemotherapy: Prior adjuvant chemotherapy allowed; No more than 1 prior chemotherapy regimen for metastatic disease; No prior taxane (docetaxel or paclitaxel;) Prior doxorubicin allowed if total dose less than 250 mg/m2; No other concurrent chemotherapy - Endocrine therapy: Prior hormonal therapy allowed; No concurrent hormonal therapy - Radiotherapy: At least 4 weeks since prior radiotherapy; No prior cumulative radiotherapy to more than 25% of bone marrow; No concurrent radiotherapy - Surgery: Not specified - Other: At least 7 days since prior antibiotics; No other concurrent investigational drugs; No other concurrent antineoplastic therapy; No concurrent parenteral antibiotics --Patient Characteristics-- - Age: 18 and over - Sex: Female - Menopausal status: Not specified - Performance status: ECOG 0-2 - Life expectancy: Not specified - Hematopoietic: WBC at least 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin normal; Alkaline phosphatase no greater than 2.5 times upper limit of normal (ULN); SGOT and SGPT no greater than 1.5 times ULN - Renal: Creatinine no greater than 2.0 mg/dL - Cardiovascular: No congestive heart failure; Ejection fraction greater than 45% by MUGA; No myocardial infarction within the past 6 months; No ischemic heart disease requiring medication; No uncontrolled hypertension - Other: No peripheral neuropathy grade 2 or more; No other prior malignancy within the past 5 years except curatively treated basal cell or squamous cell carcinoma of the skin, carcinoma in situ of the cervix, or contralateral breast cancer; No active unresolved infection; No history of hypersensitivity reaction to products containing Polysorbate 80; No poorly controlled diabetes mellitus; Not pregnant; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
DavidJohnson, Study Chair, Vanderbilt-Ingram Cancer Center
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
United States
Additional Information:
Study ID Numbers: CDR0000068114; VU-VCC-BRE-9823,NCI-G00-1830
Study Start Date: June 2000
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006104
Other Stage 4 Breast Cancer Studies:
1. Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
2. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
3. Vaccine Therapy in Treating Patients With Breast Cancer
4. Capecitabine and Paclitaxel in Treating Patients With Metastatic Breast Cancer
5. Trastuzumab, Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Pennsylvania Clinical Trials
Other Philadelphia Clinical Trials
Trastuzumab Plus Docetaxel in Treating Women With Recurrent or Metastatic Breast Cancer
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