IBCSG 25-02: A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer (TEXT).
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 11 Apr 2017
At a glance
- Drugs Exemestane (Primary) ; Tamoxifen; Triptorelin
- Indications Early breast cancer
- Focus Therapeutic Use
- Acronyms TEXT
- 13 Mar 2017 According to an Ipsen media release, the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, in coordination with fourteen other European regulatory agencies, has approved Decapeptyl as adjuvant treatment in combination with tamoxifen or an aromatase inhibitor, of endocrine-responsive early-stage breast cancer in women at high-risk of recurrence who are confirmed as pre-menopausal after completion of chemotherapy. The approval was based on results from SOFT and TEXT trials.
- 29 Jun 2016 This trial was completed in Germany, according to European Clinical Trials Database.
- 04 Apr 2016 Planned End Date changed from 1 Jun 2015 to 1 Jun 2020 as per ClinicalTrials.gov record.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History