Trial Profile
A Phase III Randomized, Open-label Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 29 Aug 2023
Price :
$35
*
At a glance
- Drugs Dabrafenib (Primary) ; Dacarbazine
- Indications Malignant melanoma
- Focus Registrational; Therapeutic Use
- Acronyms BREAK-3
- Sponsors GlaxoSmithKline; GSK
- 18 Dec 2019 Results assessing long term outcomes in patients with BRAF V600-mutant metastatic melanoma receiving dabrafenib monotherapy using data from phase 2 and 3 clinical trials (BREAK-2, NCT01153763; BREAK-3, NCT01227889) published in the European Journal of Cancer
- 03 Aug 2017 Status changed from active, no longer recruiting to completed.
- 06 Jun 2017 Results of 5 year landmark analysis for phase II BREAK 2 (data cutoff date 17 Jun 2016) and phase III BREAK 3 (data cutoff date 6 Sep 2016) studies evaluating dabrafenib monotherapy in patients with BRAF V600-mutant melanoma, presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.