Locally advanced breast cancer MedDRA version: 12.0 Level: LLT Classification code 10057654 Term: Breast cancer female
Conditions
Interventions
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Epirubicin
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Concentration number: 2-
Pharmaceutical Form: Co
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with histologically proven primary breast cancer (T2-T3 T4 a-d, N0-3, M0) T2-T4 a-d ER and PgR =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with ER and /or PgR ≥ 10% HER2 negative or positive T-2-4 a-d tumors Patients with other non-malignant uncontrolled systemic diseases that would preclude trial entry in the opinion of the investigator. Specifically not eligible are patients with uncontrolled active infection, chronic infection such as active HBV or HCV Patients with distant metastatic disease Patients with a history of any prior ipsilateral or contralateral invasive breast cancer.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to estimate the effect of preoperative chemotherapy on the change in tumor cell proliferation by assessment of Ki-67, a biomarker of cell proliferation which has been recently recognized a an independent prognostic factor after preoperative chemotherapy, in breast cancer tissue at baseline (tumor core biopsy) and at the end of the treatment (on surgical resection specimen).;Secondary Objective: The rate of pathological complete remission defined as disappearance of invasive tumor both in the breast and in the axilla; The rate of objective (complete and partial) responses; To collect and store tumor tissue, plasma samples for future analysis of molecular pathways and gene candidates;Primary end point(s): The principal endpoint of the study is the ki67 | — |
Countries
Italy
Outcome results
None listed