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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00020410
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : April 30, 2015
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

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

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.

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I Study Of Yttrium 90-labeled Monoclonal Antibody B3 With Autologous Stem Cell Support For Metastatic Breast Cancer
Study Start Date : February 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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) Identifier: NCT00020410     History of Changes
Obsolete Identifiers: NCT00006197
Other Study ID Numbers: CDR0000068405
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: September 2003

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