Patients with Refractory ?Triple Negative? Breast Cancer MedDRA version: 9.1 Level: LLT Classification code 10006187 Term: Breast cancer
Conditions
Interventions
Trade Name: CELLCEPT*100CPS 250MG
Pharmaceutical Form: Tablet
INN or Proposed INN: Mycophenolic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 250-
Trade Nam
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate safety and activity of an allogeneic peripheral blood progenitor cell (PBPC) transplantation using TLI/ATG conditioning regimen. - To evaluate the kinetics of donor haematopoietic cell engraftment and chimerism.;Secondary Objective: 1. To evaluate incidence and severity of acute GVHD 2. To evaluate the incidence and extent of chronic GVHD. 3. To document the quantitative and qualitative reconstitution of the immune system including T cell subsets, NK cells and B cells. 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 | — |
Countries
Italy
Outcome results
None listed