Primary chemotherapy in Her2-overexpressing operable breast cancer patient MedDRA version: 6.1 Level: PT Classification code 10057654
Conditions
Interventions
Trade Name: HERCEPTIN
Pharmaceutical Form: Powder for infusion*
INN or Proposed INN: Trastuzumab
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Trade Name: F
Sponsors
ISTITUTI FISIOTERAPICI OSPITALIERI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ● Histologically proven HER2-positive breast cancer ● cT2-T3 N0-N2 breast cancer ● ECOG PS status =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Prior systemic therapy for breast cancer Prior radiation therapy for breast cancer Evidence of metastatic or locally advanced disease Pre-existing neuropathy grade >= 2 by NCI criteria Cardiac diseases: previous myocardial infarction or angina pectoris, history of congestive heart failure, grade 3-4 cardiac arrhythmia, clinically significant valvular heart disease, poorly controlled hypertension Psychiatric disorders Active uncontrolled infection Active peptic ulcer, unstable diabetes mellitus Past or current history of other neoplasm except for curatively treated non-melanoma skin cancer, in situ carcinoma of the cervix Concurrent use of other experimental drugs Male patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the percentage of pCR after treatment at definite surgery;Secondary Objective: To evaluate toxicity and cardiotoxicity To evaluate pathological and molecular markers for predicting efficacy and cardiotoxicity;Primary end point(s): Complete pathological response defined as no residual invasive cancer | — |
Countries
Italy
Outcome results
None listed