Breast Cancer
Conditions
Interventions
A:Immune reconstitution of autologous dendritic cells transfusion after high-dose chemotherapy with autologous hematopoietic stem cells support
B:Immune reconstitution of selective autologous lymphocyte transfusion with regulatory T cells depletion after high-dose chemotherapy with autologous hematopoietic stem cells support
C:Immune reconstitution of cytokine IL-2 and IFN after high-dose chemotherapy with autologous hematopoietic stem cells support
Sponsors
Beijing Cancer Hospital/Peking University School of Oncology
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Breast cancer patients with metastatic or relapsed disease proved by histopathology or cytology; 2) Aged between 18 and 70, male or female; 3) With measurable tumor mass >=10mm by ultrasonic examination, CT or MR scans; 4) ECOG Performance Status 3months; 5) An interval of at lest 4 weeks from the last operation, radiation therapy and chemotherapy; 6) With normal marrow function and the peripheral blood test before treatment should in following range: WBC between 4.0*10^9/L to 10*10^9/L, Hb concentration between 95g/L to 165g/L, PLT concentration between 75*10^9/Lto 300*10^9/L7) Normal liver and kidney function; 8) With normal heart function and no history of heart failure. Electrocardiogram exam is normal; 9) No history of severe hypersensitive constitution and allergy to taxane and cytokines such as IL-2, GM-CSF, and IFN etc.; 10) Without infection diseases or skin infectious sites; 11) Patients with good compliance and agree to follow-up after treatment; 12) Inform of consents were signed voluntarily.
Exclusion criteria
Exclusion criteria: 1) Not measurable tumor or only bone metastasis; 2) ECOG Performance Status > 2 and Expectant survival < 3 months; 3) Patients having operation, radiotherapy, chemotherapy within 4 weeks; 4) Pregnant or lactated women; 5) Patients with history of congestive heart failure; 6) Patients with extensive pulmonary fibrosis or respiratory failure; 7) Dysfunction of liver or kidney (ALT, AST, Cr, and BUN raise over 1.5 times of upper limit of normal); 8) Myeloproliferative disorder or marrow metastasis; 9) With infection diseases or skin infectious sites; 10) Patients with severe cerebrovascular disease or brain metastases that affect describing the state of illness; 11) Hypersensitive constitution or allergy to taxane and cytokines such as IL-2, IFN, and GM-CSF etc; 12) Patients refuse to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse reaction events;objective response rate;Overall Survival; | — |
Countries
China
Contacts
Public ContactJun Ren
Outcome results
None listed