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Autotransplantation and Her 2 Neu Antibody Immunotherapy in Advanced Breast Cancer

Phase 1/Phase 2
18 Years
65 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Autotransplantation and Her 2 Neu Antibody Immunotherapy in Advanced Breast Cancer

OBJECTIVES: I. Determine the safety and toxicity profile, specifically cardiac toxicity, of
trastuzumab (Herceptin) following high dose chemotherapy and autologous peripheral blood
stem cell transplantation in women with metastatic breast cancer. II. Determine the time to
disease progression and disease free survival in these patients when treated with this
regimen. III. Determine the impact of trastuzumab (Herceptin) on minimal residual disease
after autologous peripheral blood stem cell transplantation as evidenced by serial
immunocytochemical analysis of bone marrow. IV. Determine the relationship between
posttransplant reconstitution of antibody dependent cellular toxicity and the efficacy of
trastuzumab (Herceptin) in these patients.

OUTLINE: This is a multicenter study. Patients undergo stem cell mobilization with growth
factors alone (filgrastim (G-CSF) and/or sargramostim (GM-CSF)) or chemotherapy followed by
growth factors (depending on center). Peripheral blood stem cells (PBSC) are then collected
by leukapheresis. Patients then receive high dose chemotherapy consisting of
cyclophosphamide IV over 1 hour and cisplatin IV over 72 hours on days -6 to -4 and
carmustine IV on day -3 or cyclophosphamide IV, thiotepa IV, and carboplatin IV over 96
hours on days -7 to -4 (depending on center). PBSC are reinfused on day 0. Patients then
receive trastuzumab IV over 30-90 minutes weekly for 1 year or until disease progression
beginning 5-8 weeks after PBSC reinfusion.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Inclusion Criteria

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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David Avigan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Beth Israel Deaconess Medical Center


United States: Federal Government

Study ID:




Start Date:

July 2000

Completion Date:

Related Keywords:

  • Breast Cancer
  • stage IV breast cancer
  • Breast Neoplasms



Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Hackensack University Medical Center Hackensack, New Jersey  07601