A phase III study comparing anastrozole, letrozole and exemestane, upfront (for 5 years) or sequentially (for 3 years after 2 years of tamoxifen), as adjuvant treatment of postmenopausal patients with endocrine-responsive breast cancer - GIM3- FATA

• Conditions: adjuvant hormono-therapy in breast cancer patients; MedDRA version: 6.1Level: PTClassification code 10006279

• Registration Number: EUCTR2006-004018-42-IT
• Lead Sponsor: IVERSITA' DEGLI STUDI DI NAPOLI FEDERICO II

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-15
• Last Update Posted: 3 April 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified