Metastatic Triple Negative Breast Cancer
Conditions
Interventions
Group 1 (Experimental arm): Chemotherapy (CT) + CT a dose metronomic + Nimotuzumab: 200 mg intravenously in 250 ml of isotonic saline for 30 minutes. The first dose will administer on the first day o
Sponsors
Center of Molecular Immunology (CIM)
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Patients who met the diagnostic criteria 2.Patients express written voluntary participation in the study by signing the informed consent. 3.Patients aged = 18 years. 4 Performance status 0-1 (ECOG) 5. measurable metastatic disease or advanced local recurrence. 6. Life expectancy greater than 3 months. 7.Laboratory parameters within normal limits defined as: Hematopoietic: Hemoglobin = 9 g / L, Total WBC = 4 x 109 cells / L, absolute neutrophil count = 1500/mm ³ Platelet count = 100 x 109 / L Liver : Operation liver within normal limits without liver disease demonstrated transaminases = 2 x ULN and total bilirubin = 2 x ULN, LDH = 1.3 x above the normal limit (ULN). Renal function: creatinine = 132 mmol / L.
Exclusion criteria
Exclusion criteria: 1. Patients who are pregnant, breastfeeding or childbirth in the 30 days prior to inclusion. 2. Metastatic disease of the central nervous system active. 3. Active or uncontrolled infections and diseases or medical conditions that prevent the patient is treated as indicated in the protocol. 4.Patients with reproductive potential not using contraception. 5. Inability to give informed consent to participate in research . 6. Patients treated with anti-EGFR therapies in the 8 weeks prior to inclusion. 7. Patients who at the time of inclusion are participating in another clinical trial. 8. Patients suffering from illnesses associated chronic phase of decompensation (eg heart disease, diabetes, hypertension). 9. Patients presenting a history of hypersensitivity or allergy to Nimotuzumab or other similar biological product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage I (Clinical Trial Phase II) Progression-free survival: Time from inclusion to the progression of neoplastic disease as defined by RECIST, version 1:1). Measuring time: 12 months Stage II (Clinical Trial Phase III) Global Survival (Time since inclusion to death). Measuring time: 24 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Neoplastic disease control (complete response + partial response + stable disease by RECIST, version 1:1). Measuring time: 12 and 24 months. Overall survival (Time from inclusion to the progression of neoplastic disease as defined by RECIST, version 1:1). Measuring time: 3, 6, 9 and 12 months. Quality of life (EORTC QLQ-C30 y QLQ-BR23). Measuring time: at baseline, 3, 6, 9, 12, 15, 18, 21 and 24 months. Laboratory Hematologic parameters (Hemoglobin, Differential leukogram, Hematocrit, Platelets, Absolute neutrophil count). Measuring time: at baseline, every 21 days during the CT and every 2 months after the CT. Laboratory hemochemical parameters (Transaminase, glycemia, bilirubin, alkaline phosphatase, creatinine, tumor marker CA 15-3). Measuring time: at baseline, every 21 days during the CT and every 2 months after the CT. Adverse Event Occurrence of a patient (Yes, No). Measuring time: in every product administration until 24 months Intensity of AE (Common Toxicity Criteria-(CTC) version 4.0 of the National Cancer Institute of the USA). Measuring time: in every product administration until 24 months Duration of the AE (Time between the beginning and the end date of the AE). Measuring time: in every product administration until 24 months Severity EA (Grave/seriously, not grave). Measuring time: in every product administration until 24 months Attitude to study treatment (No change, dose modification, temporal interruption, definitive treatment interruption). Measuring time: in every product administration until 24 months Result of the AE (Recovered, Improved, Remains, Sequelae). Measuring time: in every product administration until 24 months Causality relationship (Very likely/safe, Probable, Possible, Unlikely, Not related, Not evaluable/not classifiable). Measuring time: in every product administration until 24 months | — |
Countries
Cuba
Contacts
Public ContactMayra Ramos- Suzarte
Center of Molecular Immunology
Outcome results
None listed