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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2009-010786-22-IT
Enrollment
Unknown
Registered
2009-03-03
Start date
2009-03-03
Completion date
Unknown
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

post menopausal women with hormone-receptor positive early stage breast cancer, surgically removed MedDRA version: 9.1 Level: SOC Classification code 10038604

Interventions

Trade Name: AROMASIN Pharmaceutical Form: Tablet INN or Proposed INN: Exemestane Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Trade Name: ARIMIDEX*28CPR RIV

Sponsors

IST - ISTITUTO NAZIONALE PER LA RICERCA SUL CANCRO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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) DFS will be defined by the time elapsed from randomisation to the occourrence of the first one among the following events: - local or regional relapse - distant metastases - controlateral or ipsilateral breast cancer—

Countries

Italy

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026