adjuvant hormono-therapy in breast cancer patients MedDRA version: 6.1 Level: PT Classification code 10006279
Conditions
Interventions
Trade Name: AROMASIN
Pharmaceutical Form: Coated tablet
INN or Proposed INN: Exemestane
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Trade Name: ARIMIDEX
P
Sponsors
UNIVERSITA' DEGLI STUDI DI NAPOLI FEDERICO II
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Women with histological diagnosis of invasive breast cancer completely removed by surgery, any T, any N -Postmenopausal status -Primary tumor positive for ER or PgR (10% tumor cells positive by immunoistochemistry or  10 fmol/mg cytosol protein by ligand binding assay) -Patients with HER-2 positive tumors are eligible provided that they receive trastuzumab according to registered schedule. -Signed informed consent 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - HRT concurrent or assumed during the month before randomization - Recurrent or metastatic disease - HER-2 positive tumors if treatment with trastuzumab is not feasible - Concurrent illness that contraindicate adjuvant endocrine treatment - Patients who have received TAM as part of any breast cancer prevention trial - Previuos history of invasive breast cancer or other invasive malignancy within the previous 10 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied - Concomitant severe disease which would place the patient at unusual risk - Concurrent treatment with other experimental drugs - Patients treated with systemic investigational drugs within the past 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to compare the disease free survival (DFS) in patients treated with: ?sequential (tamoxifen 2 yrs AIs 3yrs) vs upfront (AIs 5yrs) strategy of treatment ?Anastrozole vs exemestane vs letrozole;Secondary Objective: To compare Distant-metastasis-free survival, cumulative incidence of contralateral breast cancer as first event, breast cancer-free survival, overall survival, cumulative incidence and type of second non-breast invasive cancer, toxicity;Primary end point(s): Disease-free survival (DFS) defined as the time elapsed from randomization to the first among the following events: ?local or regional relapse ?distant metastasis ?contralateral breast cancer ?other invasive cancer different than breast ?death. Survival defined as time elapsing between the date of randomization and the date of death for any cause Safety: Clinical and laboratory toxicities will be graded according to NCI criteria CTCAE (Common Terminology Criteria for Adverse Events of National Cancer Institute v.3.0). The adverse events witch are not reported in NCI criteria will be graded as: mild (1), moderate (2), severe (3), and life threatening (4) | — |
Countries
Italy
Outcome results
None listed