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Radiolabeled Monoclonal Antibody Followed by Peripheral Stem Cell Transplantation in Treating Patients With Relapsed or Metastatic Breast Cancer

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: July 11, 2001
Last updated: April 29, 2015
Last verified: September 2003

RATIONALE: Radiolabeled monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of monoclonal antibody therapy and kill more cancer cells.

PURPOSE: Phase I trial to study the effectiveness of radiolabeled monoclonal antibody followed by peripheral stem cell transplantation in treating patients who have relapsed or metastatic breast cancer.

Condition Intervention Phase
Breast Cancer
Biological: filgrastim
Procedure: peripheral blood stem cell transplantation
Radiation: yttrium Y 90 monoclonal antibody B3
Phase 1

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Phase I Study Of Yttrium 90-labeled Monoclonal Antibody B3 With Autologous Stem Cell Support For Metastatic Breast Cancer

Resource links provided by NLM:

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 2001
Detailed Description:


  • Determine the maximum tolerated dose of yttrium Y 90 monoclonal antibody B3 followed by autologous peripheral blood stem cell transplantation in patients with relapsed or metastatic breast cancer.
  • Determine the toxicity of this treatment regimen in these patients.
  • Determine the clinical response in patients treated with this regimen.

OUTLINE: This is a dose-escalation study of yttrium Y 90 monoclonal antibody B3 (Y90 MOAB B3).

Patients receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 4 days prior to peripheral blood stem cell (PBSC) collection and continuing until the target number of cells is reached.

After PBSC collection, patients receive indium In 111 monoclonal antibody B3 IV over 30-60 minutes once within days -7 to -1 for tumor imaging and then Y90 MOAB B3 IV over 30-60 minutes on day 0. After at least day 7, patients undergo autologous PBSC reinfusion. Patients receive G-CSF SC daily beginning 7 days after PBSC reinfusion and continuing until blood counts recover.

Cohorts of 3-6 patients receive escalating doses of Y90 MOAB B3 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.

Patients are followed at 1 week, 1 month, and then every 2 months thereafter.

PROJECTED ACCRUAL: A total of 20-30 patients will be accrued for this study within 24-36 months.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed stage IV breast cancer

    • At least 1 site of relapse or metastatic disease
  • Progressive disease after at least 1 prior chemotherapy regimen for metastatic disease

    • One regimen must contain an anthracycline and a taxane as adjuvant therapy or for metastatic disease
    • Prior adjuvant chemotherapy allowed
  • Measurable or evaluable disease
  • Tumor tissue must express B3 antigen on the surface of more than 30% of tumor cells
  • No CNS metastasis
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • ECOG 0-1

Life expectancy:

  • Not specified


  • Absolute granulocyte count greater than 2,000/mm^3
  • Platelet count greater than 100,000/mm^3


  • Bilirubin normal
  • SGOT and SGPT no greater than 2 times upper limit of normal
  • PT normal
  • Hepatitis B surface antigen negative
  • Hepatitis C negative


  • Creatinine no greater than 1.4 mg/dL


  • Ejection fraction at least 45% by MUGA or echocardiogram


  • FEV_1 greater than 60% of predicted
  • FVC at least 55% of predicted
  • DLCO at least 55% of predicted


  • No known seizure disorders
  • No history of autoimmune disease
  • No other active malignancy except previously treated basal cell skin cancer
  • No other concurrent medical or psychiatric condition that would preclude study participation
  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • See Chemotherapy
  • No prior mouse antibody


  • See Disease Characteristics
  • At least 4 weeks since prior chemotherapy (6 weeks for mitomycin or nitrosoureas) and recovered
  • No prior high-dose chemotherapy with bone marrow or stem cell transplantation

Endocrine therapy:

  • At least 4 weeks since prior hormonal therapy
  • No concurrent chronic steroids


  • At least 4 weeks since prior local radiotherapy to one site and recovered
  • No prior radiotherapy to the pelvis and/or spine


  • Not specified


  • No concurrent anticoagulants
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Please refer to this study by its identifier: NCT00020410

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Center for Cancer Research
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Claude Sportes, MD National Cancer Institute (NCI)
  More Information Identifier: NCT00020410     History of Changes
Obsolete Identifiers: NCT00006197
Other Study ID Numbers: CDR0000068405
Study First Received: July 11, 2001
Last Updated: April 29, 2015

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
recurrent breast cancer
male breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs processed this record on April 21, 2017