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Clinical Trials/EUCTR2008-006262-28-IT
EUCTR2008-006262-28-IT
Active, not recruiting
Not Applicable

Allogeneic Haematopoietic Cell Transplantation Using a Non-myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Patients with Refractory ?Triple Negative? Breast Cancer - ND

ISTITUTO EUROPEO DI ONCOLOGIA0 sitesApril 1, 2009
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ConditionsPatients with Refractory ?Triple Negative? Breast CancerMedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancer
DrugsCELLCEPT*100CPS 250MGTHYMOGLOBULINE

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Patients with Refractory ?Triple Negative? Breast Cancer
Sponsor
ISTITUTO EUROPEO DI ONCOLOGIA
Status
Active, not recruiting
Last Updated
13 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
April 1, 2009
End Date
TBD
Last Updated
13 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Eligibility Criteria

Inclusion Criteria

  • •1\.Histologically or cytologically proven diagnosis of breast cancer with evidence of unresectable, locally recurrent, or metastatic disease.
  • •2\.Documentation of oestrogen and progestin receptor (ER/PR) negative status and HER2/neu receptor negative status (ie, FISH or CISH (where approved) negative or immunohistochemistry 0 or \+1\).
  • •3\.Prior treatment with an anthracycline, a taxane and alkylating agents alone or in combination in the neoadjuvant, adjuvant or metastatic disease setting.
  • •4\.Measurable disease as per RECIST.
  • •5\.Male or female; patients age \> 18 and \< 70 years.
  • •6\.A fully HLA\-identical sibling donor is available. Patients with one antigen mismatched donors can be considered but only after discussion with the transplant team and the Principal Investigator.
  • •7\.Signed and dated informed consent document and willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.
  • •Are the trial subjects under 18? no
  • •Number of subjects for this age range:
  • •F.1\.2 Adults (18\-64 years) yes

Exclusion Criteria

  • •1\.Uncontrolled CNS involvement with disease
  • •2\.Females who are pregnant or fertile men or women unwilling to use contraceptive techniques during and for 12 months following treatment
  • •3\.Organ dysfunction
  • •4\.Viral infections: HIV positive patients
  • •5\.Any previous or current malignancy at other sites, with the exception of adequately treated cone\-biopsied in situ carcinoma of the cervix and adequately treated basal or squamous cell carcinoma of the skin.

Outcomes

Primary Outcomes

Not specified

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