LATER
ACTRN12607000137493
Treatment
Phase 3
Self funded/Unfunded,Novartis Pharmaceuticals Australia Pty Ltd
Prof John F Forbes
The major concern for women on long term follow up after breast cancer has been treated, is fear of the reoccurrence of disease. This study will test a new strategy to prevent disease reocurrence and death due to breast cancer. The purpose of the study is to find out whether later re-treatment of participants with adjuvant letrozole therapy can prevent or delay new breast cancers from reoccurring in postmenopausal women previously treated with adjuvant endocrine therapy
Patients must be postmenopausal, which is defined as meeting one or more of the following criteria: prior bilateral oophorectomy aged 60 years or more; if the patient has any clinical evidence of ovarian function, FSH levels must be assessed and be in the postmenopausal range. aged under 60 years: a) with a uterus and amenorrhoea for at least 12 months prior to trial entry (see Note 2) b) with amenorrhoea for less than 12 months prior to trial entry and an follicle stimulating hormone (FSH) leve .... Read more
Premenopausal patients. Patients previously diagnosed with only hormone non-responsive early breast cancer. Patients with any local recurrence or distant metastases of breast cancer. Any suspicious manifestation requires appropriate investigation to exclude metastases. Patients with non-malignant systemic diseases which would prevent prolonged followup, or in the opinion of the investigator, would place the woman at unusual risk or confound assessment for breast cancer events and the results of .... Read more
No
Sample Size 360
Min. age 45 Years
Max. age 0 Not stated
Sex Females
Condition category Endocrine Responsive Breast Cancer
Condition code Cancer
Intervention code Treatment: Drugs
Patients are randomised to the following arm: Letrozole 2.5mg orally daily for 5 years
Control group Active
Usual care
Outcome: New breast cancer events (in local, regional or distant sites, new breast cancer in the contralateral breast)Timepoint: Patients are assessed by the clinician for new breast cancer events and survival status 6 monthly in the first year and annually thereafter until year 10 on study.
Outcome: All cause mortality (death from any cause)Timepoint: Patients are assessed by the clinician for new breast cancer events and survival status 6 monthly in the first year and annually thereafter until year 10 on study.
yes
Anonymised Individual Patient Data (IPD) collected during the trial. The specific IPD to be shared (e.g. all data, published data, data of primary outcomes) will be as per the submitted research proposal and as assessed as appropriate by BCT.
Data will be made available for request after publication of the main/final study results; no end date. Note that there may be additional circumstances preventing BCT from sharing requested data as outlined in the BCT Data Sharing Guidelines.
Researchers who submit a research proposal and BCT Data Request Application, which is assessed by BCT to have appropriate scientific value. Refer to the BCT Data Sharing Guidelines
To achieve the aims in the approved proposal.