hormone receptor positive breast cancer MedDRA version: 9.1 Level: LLT Classification code 10057654 Term: Breast cancer female
Conditions
Interventions
Trade Name: FEMARA
Pharmaceutical Form: Tablet
INN or Proposed INN: Letrozole
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 2.5-
Sponsors
ISTITUTO EUROPEO DI ONCOLOGIA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Compliant postmenopausal women with operable breast cancer - Patients with histologic diagnosis of invasive breast cancer (pT1, pT2, or pT3, Nsentinelnegative, pN0(either i- or i+); M0. - Patients must have hormone receptor positive tumors properly treated by surgery. - Written informed consent - Patients must be accessible for follow-up. 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: - Patients who are premenopausal - Patients with locally advanced disease (pN1, pN2, pN3) or distant metastatic disease. - Patients with bilateral invasive breast cancer. - Patients with positive final margins (referring to only DCIS and invasive cancer, not LCIS). - Patients with a history of prior ipsilateral or contralateral invasive breast cancer. - Patients with previous or concomitant malignancy EXCEPT adequately treated (basal or squamous cell carcinoma of the skin, in situ carcinoma of the cervix or bladder, contra- or ipsilateral in situ breast carcinoma). - Patients with other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung, etc.) that would prevent prolonged follow-up. Patients with previous thrombosis (e.g., DVT) and/or embolism can be included only if medically suitable. - Patients who received neoadjuvant endocrine therapy. - Patients who were taking tamoxifen or other SERM (e.g. Raloxifene) or hormone replacement therapy (HRT) within one year prior to their breast cancer diagnosis. - Patients with psychiatric, addictive, or any disorder, which compromises ability to give informed consent for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to evaluate the biological impact in terms of increase in serum Estradiol levels after 3-month Letrozole treatment free interval at the end of 1st year of continue letrozole;Secondary Objective: to evaluate markers of endocrine, lipid and bone metabolism;Primary end point(s): increase of estradiol levels after 3 months interval free of treatment | — |
Countries
Italy
Outcome results
None listed