Advanced breast cancer
Conditions
Interventions
Treatment will be provided in an ambulatory fashion, except the first and tenth hR3 administrations. After these two administrations, patients should be hospitalized for four days to facilitate sample
Antibodies, Monoclonal, Humanized
Doxorubicin
Cyclophosphamide
Drug Therapy
Antibodies, Monoclonal
AcM hR3
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
Female
Age
19 Years to No maximum
Inclusion criteria
Inclusion criteria: 1)Female patients with histologically confirmed breast cancer. 2)Patients with breast cancer, stage III or IV. 3)Patients should not have been on oncological treatment in the last 4 weeks prior to this treatment. 4)Age >18. Children are not included in the study because there are no data available in connection with adverse events and hR3 MaB dosage combined with doxorubicin and cyclophosphamide in patients under 18 years of age. 5)General condition ECOG 60%). 6)Life expectancy over 6 months. 7)Patient’s organs and bone marrow should be working normally, as defined by the following parameters: leucocytes >3,000/ul, absolute neutrophil count >1,500/ul, platelets >100,000/ul, total bilirubin within normal limits, TGO/TGP 60 mL/min/1.73 m2 on patients with creatinine values higher than the normal values established by the institution. 8)Patients with HER1+tumors (EGF positive receptor) determined by immunohistochemical techniques. 9)The effect of hR3 monoclonal antibody on human fetuses under development is unknown. Considering this and the fact that chemotherapy can also be teratogenic, reproductive age women should use appropriate contraceptive methods (barrier, hormone or abstinence) before and during the clinical trial. Reproductive age female patients should also be pregnancy-tested negative. If a patient gets pregnant or believes she is pregnant, she should inform her doctor immediately. 10)Capacity to understand the study and readiness to sign the informed consent document.
Exclusion criteria
Exclusion criteria: 1) Patients on another product under research. 2) Patients with history of allergy attributed to chemical or biological compounds similar to hR3 monoclonal antibody or the chemotherapy used in the study. 3) Patients with uncontrolled intercurrent diseases, including active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, and psychiatric or social diseases hindering adherence to clinical trial requirements. 4) Pregnant patients. 5) Breastfeeding should be discontinued upon inclusion in the clinical trial because of potential and unknown adverse effects on infants. 6) Patients with anthracycline contraindications. 7) Patients with brain metastasis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum permissible dose and/or optimal biological dose. Measuring time: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity profile, pharmacokinetics, dose-dependent changes, systemic clearing variations. Measuring time: 12 months | — |
Countries
Cuba
Contacts
Public ContactMayra Ramos Suzarte
Center of Molecular Immunology (CIM)
Outcome results
None listed