A Phase III Trial Evaluating The Role Of Ovarian Function Suppression And The Role Of Exemestane As Adjuvant Therapies For Premenopausal Women With Endocrine Responsive Breast Cancer.
Active, no longer recruiting
Phase of Trial: Phase III
Latest Information Update: 28 Sep 2017
At a glance
- Drugs Exemestane (Primary) ; Tamoxifen (Primary) ; Goserelin; Triptorelin
- Indications Early breast cancer
- Focus Therapeutic Use
- Acronyms SOFT
- 01 Sep 2017 Results (n=1872) of exploratory analysis of TEXT and SOFT studies, published in the Annals of Oncology.
- 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.
- 21 Sep 2016 Planned primary completion date changed from 1 Jan 2014 to 1 Dec 2031.
Most Recent Events
Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History