HER-2 Positive Breast Cancer Clinical Trial
— met-HEReMYTAOfficial title:
Clinical and Translational Phase II Study of Liposomal Doxorubicin Plus Docetaxel and Trastuzumab With Metformin as Primary Systemic Therapy for Operable and Locally Advanced Recombinant Human ErbB-2 (HER2) Positive Breast Cancer
Verified date | April 2020 |
Source | Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
It is a multicenter, open-label, two stage phase II trial, to assess activity, safety and
potential early predictors of response in neoadjuvant setting. Patients with operable breast
cancer (T1c and cytologically N1-2, or cT2-3, N0-N2, M0) or locally advanced breast cancer
(T4a-d, N0-N2, M0) with overexpression or amplification of HER2 (AJCC 7th edition 2010) are
included in the study.
The primary objective is to evaluate the pathological complete response rate (pCR).
The secondary objectives are:
- to evaluate the clinical response rate (RR).
- to evaluate the feasibility and systemic tolerance, with particular attention to cardiac
toxicity.
- to evaluate the conservative surgery rate.
Total duration of the trial is 36 months; planned treatment are 6 cycles of chemotherapy. At
every cycle (every 21 days) will be administered:
Day 1: Liposome-encapsulated doxorubicin, 50 mg/m2 IV 1 hour infusion; Day 2 and 9:
Docetaxel, 30 mg/m2 IV 1 hour infusion; Day 2, 9 and 16: Trastuzumab 4 mg/kg for the first
infusion loading dose, then 2 mg/kg/week for subsequent injections. Day -13 to 0: Metformin
is administered as single agent. From day -13 to day -11, Metformin 1000 mg will be
administered once a day; from day -10 Metformin 1000 mg will be administered twice a day
continuously until end of the study treatment.
Status | Completed |
Enrollment | 49 |
Est. completion date | April 2020 |
Est. primary completion date | October 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility |
Inclusion Criteria: - Patients must have histologically confirmed breast cancer - HER2 overexpressing cancer - Patients with operable breast cancer (T1c and cytologically N1-2, or cT2-3, N0-N2, M0) or locally advanced breast cancer (T4a-d, N0-N2, M0) (AJCC 7th edition 2010). - No prior therapy for breast cancer - Both sexes, age = 18 years and < 75 years - Eastern Cooperative Oncology Group (ECOG) performance status 0-1 - Life expectancy > 3 months - Neutrophil count = 2 x 109/ L, leukocytes count = 3 x 109/ L and platelet count = 100 x 109/ L - Total bilirubin = 1 upper-normal limits (UNL) of the Institutional normal values and alanine aminotransferase (ASAT (GOT) and/or alanine aminotransferase 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 eligible for the trial. - Creatinine = 1.5 mg/dL - Left ventricular ejection fraction (LVEF) = 50% (evaluated by echocardiogram or multiple gated acquisition scan (MUGA) scan -only one method must be employed for each patient) - Written informed consent - Homa Index calculated using the Matthews'formula EXCLUSION CRITERIA: - Prior chemotherapy or radiotherapy for breast cancer. - History of prior malignancy in the last 10 years (other than non-melanoma skin cancer or excised cervical carcinoma in situ). - Other serious illness or medical condition - Congestive heart failure or angina pectoris even if medically controlled. Previous history of myocardial infarction, uncontrolled high risk hypertension or arrhythmia - History of significant neurologic or psychiatric disorders including dementia or seizures - Active infection - Concurrent treatment with other experimental drugs. - Participation in another clinical trial with any investigational agents within 30 days prior to study screening. - Geographic inaccessibility to treatment and followup - Pregnant and lactating women - Diabetes-insulin dependant and non-insulin dependant |
Country | Name | City | State |
---|---|---|---|
Italy | Oncologia Medica AOU Ferrara | Ferrara | FE |
Italy | Day Hospital Oncologico, Ospedale Guastalla | Guastalla | |
Italy | Oncologia Medica AUSL Imola | Imola | |
Italy | IRST Oncologia medica | Meldola | FC |
Italy | Oncologia Medica, Policlinico di Modena | Modena | MO |
Italy | Oncologia Medica AOU Parma | Parma | |
Italy | Oncologia Medica Ospedale Guglielmo da Saliceto | Piacenza | PC |
Italy | Oncologia , IRCCS azienda ospedaliera S.Maria Nuova | Reggio Emilia | RE |
Italy | U.O Oncologia AUSLdella Romagna | Rimini | RN |
Lead Sponsor | Collaborator |
---|---|
Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pathologic complete response rate(pCR) | Complete pathologic response will be defined as no invasive residuals in breast and axillary nodes. In situ tumor residuals are considered as complete response rate | up to 36 months | |
Secondary | clinical response rate (RR) | The clinical response rate (RR) will be including Pathological Complete Response, Clinical Complete Response and Clinical Partial Response (Response Evaluation Criteria in Solid Tumors (RECIST) criteria). | up to 36 months | |
Secondary | evaluation of toxicity | All patients will be evaluable for toxicity from the time of their first treatment with Metformine. The toxicity will be recorded according to the CTC-AE, version 4.0 in the safety population until Follow-up is completed (36 months) | up to 36 months | |
Secondary | conservative surgery rate | evaluation of the number of patients who underwent conservative surgery | up to 36 months |
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