CLINICAL AND TRASLATIONAL PHASE II STUDY OF LIPOSOMAL DOXORUBICIN PLUS DOCETAXEL AND TRASTUZUMAB WITH METFORMIN AS PRIMARY SYSTEMIC THERAPY FOR OPERABLE AND LOCALLY ADVANCED HER2 POSITIVE BREAST CANCER. - met-HEReMYTA

ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI IRST - IRCCS0 个研究点开始时间: 2014年8月4日最近更新: 2015年3月9日

适应症

试验速览

暂无简介。

•1. Patients must have histologically confirmed breast cancer
•2. HER2 overexpressing cancer
•3. Patients with operable breast cancer (T1c and citologically N1-2, or cT2-3, N0-N2, M0) or locally advanced breast cancer (T4a-d, N0-N2, M0) (AJCC 7th edition 2010).
•4. Both sexes, age = 18 years and < 75 years
•5. ECOG performance status 0-1
•6. Life expectancy > 3 months
•7. Neutrophil count = 2 x 109/ L, leukocytes count = 3 x 109/ L and PLT = 100 x 109/ L
•8. Total bilirubin = 1 upper-normal limits (UNL) of the Institutional normal values and ASAT (GOT) and/or ALAT (GPT) = 2.5 UNL, alkaline
•phosphatase = 5 UNL. Patients with ASAT and/or ALAT > 1.5 UNL and alkaline phosphatase > 2.5 UNL aren’t elegible for the trial.
•9. Creatinine = 1.5 mg/dL
•10. Left ventricular ejection fraction (LVEF) = 50% (evaluated by echocardiogram or MUGA scan – only one method must be employed for each patient)
•11. Written informed consent
•12. Homa Index calculated using the Matthews’ formula (Appendix B)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 40
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 6

•1. Prior chemotherapy or radiotherapy for breast cancer.
•2. History of prior malignancy in the last 10 years (other than non-melanoma skin cancer or excised cervical carcinoma in situ).
•3. Other serious illness or medical condition
•4. Congestive heart failure or angina pectoris even if medically controlled. Previous history of myocardial infarction, uncontrolled high risk hypertension or arrhythmia
•5. History of significant neurologic or psychiatric disorders including dementia or seizures
•6. Active infection
•7. Concurrent treatment with other experimental drugs.
•8. Participation in another clinical trial with any investigational agents within 30 days prior to study screening.
•9. Geographic inaccessibility to treatment and followup
•10. Pregnant and lactating women
•11. Patients with severe dyspnoea at rest due to massive pulmonary involvement by the tumor or who require supplemental oxygen therapy
•12. Diabetes-insulin dependent and non insulindependent

发起方

ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI IRST - IRCCS