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Home > "C" Clinical Trials Conditions > Combination Chemotherapy With or Without Trastuzumab in Treating Women With Metastatic Breast Cancer  Combination Chemotherapy With or Without Trastuzumab in Treating Women With Metastatic Breast Cancer
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: Recruiting
Sponsor(s): Eastern Cooperative Oncology Group , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy with or without trastuzumab in treating women who have metastatic breast cancer.
Details: OBJECTIVES: - Assess the safety, toxicity, and feasibility of doxorubicin HCl liposome and docetaxel with or without trastuzumab (Herceptin) in patients with metastatic breast cancer, particularly with respect to cardiotoxicity. - Assess the overall objective response rate, response duration, time to treatment failure, and median survival in these patients with these treatment regimens. - Assess any association between trough plasma levels of cardiac troponin T and brain natriuretic peptide and any cardiac event (congestive heart failure or LVEF decrease). OUTLINE: Patients are assigned to one of two treatment arms according to HER2 overexpression status. - Patients receive doxorubicin HCl liposome IV over 30 minutes followed by docetaxel IV over 1 hour. Treatment is repeated every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. Patients may receive maintenance therapy of docetaxel IV over 1 hour either weekly or every 3 weeks. Maintenance continues in the absence of disease progression or unacceptable toxicity. - Patients receive trastuzumab IV over 90 minutes on day 1, with subsequent doses over 30 minutes. Patients receive doxorubicin HCl liposome IV over 30 minutes followed by docetaxel IV over 1 hour on day 2 of course 1, followed by subsequent doses on day 1 of each course. Antibody therapy continues weekly and chemotherapy every 3 weeks for 8 courses. Patients may receive maintenance therapy of trastuzumab IV over 30 minutes weekly followed by docetaxel IV over 1 hour weekly or every 3 weeks. Maintenance continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 92 patients (46 per arm) will be accrued for this study within 13 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic adenocarcinoma of the breast - HER2 nonoverexpressed (0-1+) OR overexpressed (2-3+) - Measurable or evaluable disease - Pleural or peritoneal effusions allowed if local intracavitary treatment not started at onset of therapy - Blastic or mixed blastic/lytic osseous metastases allowed if accompanied by pain or decreased performance status, and do not require radiotherapy within two courses of study therapy - Osteolytic disease allowed if proven by x-ray - No abnormal bone scan without confirmatory x-rays as only evidence of metastatic disease - Prior brain metastases responsive to treatment of radiotherapy and/or surgery allowed (cannot be only site of metastases) - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female Menopausal status: - Not specified Performance status: - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - SGOT no greater than 2.5 times upper limit of normal - Bilirubin normal Renal: - Creatinine no greater than 1.5 mg/dL Cardiovascular: - No prior deep venous thrombosis or thromboembolic condition - LVEF at least lower limit of normal - No prior myocardial infarction or congestive heart failure - No arrhythmia requiring medication - No hypertension or systolic or diastolic dysfunction - No ventricular hypertrophy or conduction abnormality Pulmonary: - No prior pulmonary thromboembolism Other: - No other malignancy within past 5 years except curatively treated carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin - Not pregnant or nursing - Fertile women must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No prior trastuzumab (Herceptin) Chemotherapy: - No prior chemotherapy for advanced or local/regional recurrent disease - Prior adjuvant chemotherapy allowed if completed 6 months before metastasis - No prior anthracyclines or anthracenediones Endocrine therapy: - At least 2 weeks since prior hormonal therapy Radiotherapy: - Prior radiotherapy allowed only to conserved breast, postmastectomy chest wall with or without internal mammary lymph node chain (IMN), or field containing less than 25% bone marrow - No prior photon IMN treatment - At least 2 weeks since prior radiotherapy - No concurrent radiotherapy Surgery: - At least 2 weeks since surgery (including mastectomy) and recovered
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AntonioWolff, Study Chair, Sidney Kimmel Cancer Center
CCOP - Merit Care Hospital *Recruiting*
Fargo, North Dakota, 58122
United States
Recruiting Preston Steen 701-234-6161
Veterans Affairs Medical Center - Lakeside Chicago *Recruiting*
Chicago, Illinois, 60611-4494
United States
Recruiting Timothy Kuzel 312-469-3748
CCOP - Northern Indiana CR Consortium *Recruiting*
South Bend, Indiana, 46601
United States
Recruiting Rafat Ansari 574-284-7977
Albert Einstein Clinical Cancer Center *Recruiting*
Bronx, New York, 10461
United States
Recruiting Joseph Sparano 718-904-2555
CCOP - Metro-Minnesota *Recruiting*
St. Louis Park, Minnesota, 55416
United States
Recruiting Patrick Flynn 952-993-15175
CCOP - Marshfield Clinic Research Foundation *Recruiting*
Marshfield, Wisconsin, 54449
United States
Recruiting Tarit Banerjee 715-387-5134
Tufts - New England Medical Center *Recruiting*
Boston, Massachusetts, 02111
United States
Recruiting John Erban 617-636-5147
CCOP - Sioux Community Cancer Consortium *Recruiting*
Sioux Falls, South Dakota, 57104
United States
Recruiting Loren Tschetter 605-328-8044
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins *Recruiting*
Baltimore, Maryland, 21231
United States
Recruiting Antonio Wolff 410-614-4192
CCOP - Kalamazoo *Recruiting*
Kalamazoo, Michigan, 49007-3731
United States
Recruiting Raymond Lord 269-373-7488
Pretoria Academic Hospital *Recruiting*
Pretoria, , 0001
South Africa
Recruiting Coenraad Slabber 27-12-354-1054
CCOP - Duluth *Recruiting*
Duluth, Minnesota, 55805
United States
Recruiting Robert Dalton 218-786-8364
MBCCOP-Our Lady of Mercy Cancer Center *Recruiting*
Bronx, New York, 10466
United States
Recruiting Peter Wiernik 718-920-1100
CCOP - St. Vincent Hospital Cancer Center, Green Bay *Recruiting*
Green Bay, Wisconsin, 54307-3453
United States
Recruiting Gerald Bayer 920-433-8889
Cancer Institute of New Jersey *Recruiting*
New Brunswick, New Jersey, 08903
United States
Recruiting Joseph Aisner 732-235-7464
CCOP - MainLine Health *Recruiting*
Wynnewood, Pennsylvania, 19096
United States
Recruiting Paul Gilman 610-645-2057
CCOP - Carle Cancer Center *Recruiting*
Urbana, Illinois, 61801
United States
Recruiting Kendrith Rowland 217-383-4083
CCOP - Iowa Oncology Research Association *Recruiting*
Des Moines, Iowa, 50309-1016
United States
Recruiting Roscoe Morton 515-244-7586
Penn State Cancer Institute at Milton S. Hershey Medical Center *Recruiting*
Hershey, Pennsylvania, 17033-0850
United States
Recruiting Witold Rybka 717-531-1050
Winship Cancer Institute of Emory University *Recruiting*
Atlanta, Georgia, 30322
United States
Recruiting William Wood 404-778-5180
Robert H. Lurie Comprehensive Cancer Center at Northwestern University *Recruiting*
Chicago, Illinois, 60611
United States
Recruiting Al Benson 312-695-1382
MetroHealth Medical Center *Recruiting*
Cleveland, Ohio, 44109
United States
Recruiting Edward Mansour 216-778-4394
Additional Information:
Study ID Numbers: CDR0000067564; ECOG-3198
Study Start Date:
Record last reviewed: December 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004888
Other Stage 4 Breast Cancer Studies:
1. Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer
2. Methotrexate With or Without Antineoplaston Therapy in Treating Postmenopausal Women With Advanced Refractory Breast Cancer
3. Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer
4. Evaluation of Drug Resistance in Patients With Metastatic Breast Cancer
5. Combination Chemotherapy With Trastuzumab in Treating Women With Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Wisconsin Clinical Trials
Other Marshfield Clinical Trials
Combination Chemotherapy With or Without Trastuzumab in Treating Women With Metastatic Breast Cancer
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