Phase II / III. Nimotuzumab in patients with triple-negative breast cancer.
- Conditions
- Metastatic Triple Negative Breast Cancer
- Registration Number
- RPCEC00000178
- Lead Sponsor
- Center of Molecular Immunology (CIM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 222
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Stage I (Clinical Trial Phase II)<br>Progression-free survival: Time from inclusion to the progression of neoplastic disease as defined by RECIST, version 1:1). Measuring time: 12 months<br>Stage II (Clinical Trial Phase III) <br>Global Survival (Time since inclusion to death). Measuring time: 24 months<br>
- Secondary Outcome Measures
Name Time Method