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

• Conditions: Patients with Refractory ?Triple Negative? Breast Cancer; MedDRA version: 9.1Level: LLTClassification code 10006187Term: Breast cancer

• Registration Number: EUCTR2008-006262-28-IT
• Lead Sponsor: ISTITUTO EUROPEO DI ONCOLOGIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04-01
• Last Update Posted: 26 June 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate safety and activity of an allogeneic peripheral blood progenitor cell (PBPC) transplantation using TLI/ATG conditioning regimen.<br> - To evaluate the kinetics of donor haematopoietic cell engraftment and chimerism.;Secondary Objective: 1.To evaluate incidence and severity of acute GVHD<br>2.To evaluate the incidence and extent of chronic GVHD.<br>3.To document the quantitative and qualitative reconstitution of the immune system including T cell subsets, NK cells and B cells.<br>4.To evaluate the rate of relapse, overall and event-free survival and transplant related mortality rate.;Primary end point(s): PFS at 6 months