Breast Cancer Clinical Trial
Official title:
Autotransplantation and Her 2 Neu Antibody Immunotherapy in Advanced Breast Cancer
Verified date | May 2018 |
Source | Dana-Farber Cancer Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
RATIONALE: Chemotherapy uses different ways to stop tumor cells from dividing so they stop
growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow
the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. 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 I/II trial to study the effectiveness of chemotherapy and peripheral stem cell
transplantation followed by trastuzumab in treating women who have metastatic breast cancer.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2000 |
Est. primary completion date | July 2000 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 65 Years |
Eligibility |
DISEASE CHARACTERISTICS: Histologically confirmed stage IV breast cancer that overexpresses
HER2/neu Evidence of at least a partial response (at least 50% reduction) to salvage
chemotherapy as initial chemotherapy for metastatic disease Measurable disease not required
if there is no disease progression at induction chemotherapy Bone lesions as only site of
metastatic disease allowed if evidence of clinical improvement and no new lesions on x-ray
No CNS metastases Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 to physiologic 65 Sex: Female Menopausal status: Pre or postmenopausal Performance status: Karnofsky 80-100% Life expectancy: At least 6 months Hematopoietic: WBC at least 2,500/mm3 Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 2.5 times ULN Renal: Creatinine no greater than 2.0 mg/dL Cardiovascular: LVEF at least 45% by radionucleotide ventriculogram No uncontrolled hypertension No unstable angina No New York Heart Association class IV heart disease or congestive heart failure No coronary angioplasty or myocardial infarction within past 6 months No uncontrolled atrial or ventricular cardiac arrhythmias Pulmonary: FEV1 and DLCO at least 50% Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No insulin dependent diabetes mellitus No uncontrolled active systemic infection No other significant nonmalignant disease No other malignancy in past 5 years except surgically cured nonmelanoma skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: Prior trastuzumab allowed No prior bone marrow or peripheral blood stem cell transplantation Chemotherapy: See Disease Characteristics Prior doxorubicin not to exceed total cumulative dose of 360 mg/m2 No more than 6 standard courses of pretransplant salvage chemotherapy No more than 3 months of prior weekly taxane therapy More than 1 chemotherapy regimen allowed with no progression during chemotherapy Endocrine therapy: Concurrent tamoxifen therapy allowed for estrogen receptor positive patients who have not received prior hormonal therapy No other concurrent hormonal therapy Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: Concurrent pamidronate allowed for bone lesions |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Hackensack University Medical Center | Hackensack | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Beth Israel Deaconess Medical Center |
United States,
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