EUCTR2011-000490-30-ES
Active, not recruiting
Phase 1
Phase II randomised, open-label, multicentric clinical trial of neoadjuvant treatment comprising chemotherapy and trastuzumab with or without metformin, in women with HER2/ErbB2 positive primary breast cancer.
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Institut Català d'Oncologia
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Mujeres.
- •2\. Edad 18\-75 años.
- •3\. Puntuación 0\-1 de la clasificación ECOG (Eastern Cooperative Oncology Group) (ver ApéndiceB).
- •4\. Cáncer de mama invasivo confirmado histológicamente (incluido el cáncer de mama inflamatorio y el cáncer de mama multifocal:)
- •\- Tumor primario mayor de 2 cm. de diámetro, medido por examen clínico y por mamografía o ecografía.
- •\- Cualquier N
- •\- Sin evidencia de metástasis (M0\), (un ganglio supraclavicular aislado afectado está permitido).
- •Se seguirá la 7ª edición del AJCC Cancer Staging Manual (ver Apéndice C).
- •5\. Sobre\-expresión y/o amplificación de HER2 en el componente invasivo del tumor primario, definido según el siguiente criterio:
- •\- IHC 2\+ y FISH/CISH positivo
Exclusion Criteria
- •1\. Prior treatment for primary invasive breast cancer.
- •2\. Bilateral breast cancer.
- •3\. Precedent medical history less than 10 years or present history for other malignant neoplasia, except in situ carcinoma of the cervix and basocellular and epidermoid skin carcinoma. Previous diagnosis of melanoma or breast cancer are excluded.
- •4\. Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarct, uncontrolled hypertension, dyspnea at rest, or chronic therapy with oxygen.
- •5\. Metabolic disease (diabetes mellitus type I or II, obesity (BMI ? 30\), hyperglycemia (preprandial glucose \>128 mg/dl), hypercholesterolemia or hypertrigliceridemia ? grade 3 according to CTC\-NCIC version 3\.0\.
- •6\. History of metabolic acidosis.
- •7\. Chronic neumopathy or respiratory restriction.
- •8\. Concurrent disease or condition that would make the patient inappropriate for study participation or any serious medical disorder that would interfere with the patient's safety.
- •9\. Active or uncontrolled infection.
- •10\. Enolism. (daily media consumption of more than 3 alcoholic beverage intake)
Outcomes
Primary Outcomes
Not specified
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