Women age 60 or older with operable and hormone receptor positive breast cancer
Conditions
Interventions
Trade Name: Femar
Pharmaceutical Form: Tablet
INN or Proposed INN: letrozole
CAS Number: 9578
Sponsors
DBCG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Unilateral breast cancer Histological confirmation of invasive breast cancer Tumor size larger than 1 cm ER positive tumor HER2 negative tumor 60 years of age or older Performance (WHO) 0, 1 or 2. Co-morbidity index (Charlson) 0,1 , 2 or 3 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: Prior systemic anticancer therapy Distant metatstasis or loco-regional advanced disease Other malignanct disease within 5 years, except c. insitu cervicis uterii or c. cuti Treatment with a experimental or non-approved drug within 30
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare invasive disease-free survival after preoperative and postoperative with postoperative letrozole.;Secondary Objective: To compare overall survival, survival without loco-regional recurrence, survival without distant recurrence, survival without secondary breast cancer after preoperative and postoperative with postoperative letrozole. To evaluate the use of sentinel node procedure after preoperative letrozole, and the lymph node status in the axilla. To reevaluate ER, PgR and HER2 after 4 months of preoperative letrozole, and evaluate the use of biomarkers to predict the response to preoperative letrozole.;Primary end point(s): Invasive disease-free survival | — |
Countries
Denmark
Outcome results
None listed