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Home > "T" Clinical Trials Conditions > Trastuzumab Plus Paclitaxel in Treating Women With Metastatic Breast Cancer That Overexpresses HER2  Trastuzumab Plus Paclitaxel in Treating Women With Metastatic Breast Cancer That Overexpresses HER2
Trastuzumab Plus Paclitaxel in Treating Women With Metastatic Breast Cancer That Overexpresses HER2
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering 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 monoclonal antibody therapy with chemotherapy may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of two different regimens of trastuzumab plus paclitaxel in treating women who have metastatic breast cancer that overexpresses HER2.
Details: OBJECTIVES: I. Evaluate the safety and tolerability of subcutaneous trastuzumab (Herceptin) plus paclitaxel in women with HER2 overexpressing metastatic breast cancer. II. Assess the activity of this treatment regimen in these patients. III. Determine the pharmacokinetics of trastuzumab and paclitaxel in this regimen. PROTOCOL OUTLINE: This is a randomized, open label, multicenter study. Patients are randomized to one of two treatment arms. Patients receive a loading dose of trastuzumab (Herceptin) IV over 90 minutes followed by paclitaxel IV over 3 hours on day 0. Paclitaxel is repeated every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. Arm I: Patients receive trastuzumab subcutaneously (SC) weekly starting day 7. Arm II: Patients receive trastuzumab SC twice weekly starting day 7. Treatment with trastuzumab SC continues for 48 weeks in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 80 patients (40 per treatment arm) 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-- - HER2 overexpressing (3+) metastatic breast cancer by immunohistochemistry, or amplified by fluorescent in situ hybridization (FISH) - No prior chemotherapy for breast cancer metastases - No bilateral disease - Bidimensionally measurable disease; At least 1 target lesion greater than 1 cm2 - No significant lymphedema in the arm ipsilateral to mastectomy site, unless patient has an indwelling catheter for the purpose of chemotherapy infusion - No CNS metastases - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: At least 14 days since prior immunotherapy; No prior trastuzumab (Herceptin); No other concurrent immunotherapy - Chemotherapy: See Disease Characteristics; Prior cytotoxic chemotherapy allowed in adjuvant setting; Prior cumulative doxorubicin exposure no greater than 300 mg/m2; At least 1 year since prior taxane therapy; No other concurrent chemotherapy - Endocrine therapy: At least 14 days since prior hormonal therapy; No concurrent hormonal therapy (e.g., tamoxifen, megestrol acetate, fluoxymesterone, or aminoglutethimide) - Radiotherapy: At least 14 days since prior radiotherapy; No concurrent radiotherapy to target lesions - Surgery: Not specified - Other: At least 30 days since other prior investigational agent or procedure; No other concurrent investigational agents --Patient Characteristics-- - Age: 18 and over - Sex: Female - Menopausal status: Not specified - Performance status: Karnofsky 70-100% - Life expectancy: Not specified - Hematopoietic: Hemoglobin at least 9.0 g/dL; WBC at least 3,000/mm3; Platelet count at least 100,000/mm3; Granulocyte count at least 1,500/mm3 - Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN); ALT, AST, and alkaline phosphatase no greater than 2.5 times ULN (no greater than 4.0 times ULN with liver or bone metastases) - Renal: Creatinine no greater than 1.5 times ULN - Cardiovascular: No clinically significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, unstable angina, intractable arrhythmia, congestive heart failure, or New York Heart Association class II-IV heart disease); Left ventricular ejection fraction at least 50% or above lower limit of normal, whichever is lower - Other: No severe hypersensitivity to products containing Cremophor EL (e.g., cyclosporine or teniposide for injection concentrate); No other serious medical condition that would preclude study; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AndrewSeidman, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Additional Information:
Study ID Numbers: CDR0000067790; GENENTECH-H1994g,NCI-G00-1769,MSKCC-99118
Study Start Date: January 2000
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005635
Other Stage 4 Breast Cancer Studies:
1. Docetaxel in Treating Patients With Metastatic Breast Cancer
2. Combination Chemotherapy and Peripheral Stem Cell Transplantation Followed by Interleukin-2 and Sargramostim in Treating Patients With Inflammatory Stage IIIB or Metastatic Stage IV Breast Cancer
3. Two Dose Levels of Capecitabine With Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer Who Have Not Responded to Previous Anthracycline-Based Chemotherapy
4. Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer
5. Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Trastuzumab Plus Paclitaxel in Treating Women With Metastatic Breast Cancer That Overexpresses HER2
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