OPERABLE AND LOCALLY ADVANCED HER2 POSITIVE BREAST CANCER. MedDRA version: 17.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Myocet
Pharmaceutical Form: Powder, dispersion and solvent for concentrate for dispersion for infusion
INN or Proposed INN: NA
CAS Number: 23214-92-8
Current Sponsor code: NA
Other descrip
Sponsors
ISTITUTO SCIENTIFICO ROMAGNOLO PER LO STUDIO E LA CURA DEI TUMORI IRST - IRCCS
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the pathologic complete response rate (pCR).;Secondary Objective: - 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.;Primary end point(s): Pathologic complete response rate (pCR).;Timepoint(s) of evaluation of this end point: 42 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): · 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.;Timepoint(s) of evaluation of this end point: 42 months | — |
Countries
Italy
Contacts
Public ContactCentro di Coordinamento Studi IRST
IRST - IRCCS
Outcome results
None listed