Open label, phase III, multicentric randomised trial, comparing five years of treatment with a non steroidal aromatase inhibitor, either anastrozole or letrozole, versus switching after 2-3 years to the steroidal aromatase inhibitor exemestane in early stage breast cancer patients. - DOUBLE
- Conditions
- MedDRA version: 9.1Level: SOCClassification code 10038604post menopausal women with hormone-receptor positive early stage breast cancer, surgically removed
- Registration Number
- EUCTR2009-010786-22-IT
- Lead Sponsor
- IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- Not specified
1) Women with histologically proven invasive breast cancer completely removed
by surgery, any pT, any pN
2) Postmenopausal status defined by at least one of the following conditions:
Age > 60 years
. Age between 45 and 59 years satisfying one or more of the following criteria:
a)amenorrhea for > 12 months and intact uterus; b)amenorrhea for < 12 months
and prior hysterectomy or prior chemotherapy with a FSH level of 50 IU/l or
more; c)prior bilateral oophorectomy
3) Positive ER and/or PgR (according to local cut-off)
4) Adjuvant/neoadjuvant chemotherapy, if given, must be completed before
enrolement
5) Patients with HER-2 positive tumors are eligible provided that they have
received trastuzumab according to registered scheduled
6) 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
1) Concurrent HRT
2) Clinical evidence of recurrent or metastatic disease (M1) at randomization
3) Previous history of invasive breast cancer or other malignancy whitin the
previous 10 years, other than squamous or basal cell carcinoma of the skin or
carcinoma in situ of the cervix
4) Concomitant severe disease and/or any condition which can contraindicate
continuing with an aromatase inhibitor or that might jeopardize patient
participation
5) Treatment with other experimental drugs.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To test whether switching to exemestane will be able to reduce the risk of recurrence of postmenopausal women initially assigned to either anastrozole or letrozole as compared to those who will complete 5 years of treatment with the same non steroidal inhibitor;Secondary Objective: whether this benefit might translate into a mortality benefit as well.;Primary end point(s): Disease free survival (DFS) <br>DFS will be defined by the time elapsed from randomisation to the occourrence of the first one among the following events:<br>-local or regional relapse<br>-distant metastases<br>-controlateral or ipsilateral breast cancer
- Secondary Outcome Measures
Name Time Method