Allogeneic Peripheral Stem Cell Transplantation in Treating Patients With Stage IV 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: NCT00020176
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 20, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy used to kill tumor cells.

PURPOSE: Phase II trial to study the effectiveness of allogeneic peripheral stem cell transplantation in treating patients who have stage IV breast cancer.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: filgrastim Biological: therapeutic allogeneic lymphocytes Drug: cyclophosphamide Drug: cyclosporine Drug: fludarabine phosphate Procedure: peripheral blood stem cell transplantation Phase 2

Detailed Description:


  • Determine the ability of T-cell-depleted allogeneic blood stem cell transplantation after an immunoablative conditioning regimen to induce a state of mixed host/donor chimerism in patients with metastatic breast cancer.
  • Determine the ability of this treatment regimen to induce an allogeneic graft-versus-tumor response in these patients.
  • Determine the feasibility of giving other approved therapies to these patients at the first sign of disease progression in order to stabilize or produce a minimal or partial response.

OUTLINE: Patients receive chemotherapy comprising fludarabine IV over 30 minutes and cyclophosphamide IV over 1 hour on days 1-4. Patients receive filgrastim (G-CSF) SC daily beginning on day 5 and continuing until blood counts recover. Treatment repeats every 21 days for a maximum of 2 courses.

Patients receive a transplantation preparative regimen comprising fludarabine IV over 30 minutes and cyclophosphamide IV over 2 hours on days -6 to -3 (beginning on day 22 of immune-depleting chemotherapy) followed by allogeneic peripheral blood stem cell transplantation IV on day 0. Patients receive G-CSF SC daily beginning on day 0 and continuing until blood counts recover, plus cyclosporine IV over 1-2 hours every 12 hours on days -1 to 14 and then orally until day 40.

Patients with persistent malignant disease and less than grade II acute graft-versus-host disease receive donor lymphocytes IV on days 42, 70, and 98.

Patients are followed twice weekly until day 100, and then at 6, 9, 12, 18, and 24 months.

PROJECTED ACCRUAL: A maximum of 70 patients will be accrued for this study within 24 months.

Study Type : Interventional  (Clinical Trial)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Allogeneic Breast Protocol 1: T-Cell Depleted Allogeneic Blood Stem Cell Transplantation Using an Immunoablative Conditioning Regimen in Metastatic Breast Cancer
Study Start Date : June 2000
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Stage IV breast cancer
  • Measurable disease
  • Progressive disease

    • Increase in disease mass or less than partial response to therapy
    • At least one prior chemotherapy regimen for metastatic disease and progressed

      • Must have received prior therapy with a taxane and an anthracycline
  • Estrogen/progesterone receptor-positive patients must have received and progressed on at least one hormonal agent in adjuvant or metastatic setting
  • Her2-neu-expressing patients must have received and progressed on trastuzumab (Herceptin®) in adjuvant or metastatic setting
  • Prior autologous stem cell transplantation allowed if less than complete response or disease progression in adjuvant or metastatic setting
  • Consenting first-degree relative with at least 5 out of 6 HLA-antigen match (may include mismatch at the D locus)
  • Hormone receptor status:

    • Estrogen receptor status known
    • Progesterone receptor status known



  • 18 to 70


  • Male or female

Menopausal status:

  • Not specified

Performance status:

  • Karnofsky 80-100%

Life expectancy:

  • More than 6 months


  • Not specified


  • Bilirubin ≤ 2 mg/dL
  • SGOT < 4 times upper limit of normal
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative


  • Creatinine ≤ 1.5 mg/dL
  • Creatinine clearance ≥ 50 mL/min


  • Left ventricular ejection fraction > 45%


  • DLCO ≥ 50% of predicted


  • HIV negative
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • See Disease Characteristics
  • Recovered from prior stem cell transplantation


  • See Disease Characteristics

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent steroids


  • Not specified


  • Not specified

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): NCT00020176

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
NCI - Center for Cancer Research
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Principal Investigator: Michael R. Bishop, MD National Cancer Institute (NCI)

Publications of Results:
Bishop MR, Kasten-Sportes C, Dean R, et al.: Preemptive DLI after T cell-depleted reduced-intensity allogeneic HSCT for metastatic breast cancer: effect on engraftment, GVHD, and anti-tumor response. [Abstract] Blood 102 (11): A- 5567, 2003.
Bishop MR, Marchigiani D, Grasmeder S, et al.: Demonstration of clinical responses to adoptive cellular therapy using allogeneic T cells in metastatic breast cancer. [Abstract] Proceedings of the American Society of Clinical Oncology 22: A-657, 2003.
Bishop MR, Marchigiani D, Odom J, et al.: Contribution of T cells to engraftment: a comparison of T cell depleted vs. T cell replete allografts after reduced-intensity conditioning. [Abstract] Blood 102 (11): A-2447, 2003.

Other Publications: Identifier: NCT00020176     History of Changes
Obsolete Identifiers: NCT00005568
Other Study ID Numbers: CDR0000067899
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 20, 2013
Last Verified: November 2004

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
Fludarabine phosphate
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Enzyme Inhibitors
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Calcineurin Inhibitors
Antimetabolites, Antineoplastic