A Phase Ib Dose Escalation Study of the Combination of LEE011 With Letrozole and Dose Expansion of LEE011 With Hormonal Therapy for the Treatment of Pre-(With Goserelin) and Postmenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
Active, no longer recruiting
Phase of Trial: Phase I
Latest Information Update: 21 Feb 2018
At a glance
- Drugs Ribociclib (Primary) ; Fulvestrant; Goserelin; Letrozole; Tamoxifen
- Indications Advanced breast cancer
- Focus Adverse reactions
- Acronyms MONALEESASIA
- Sponsors Novartis; Novartis Pharmaceuticals
- 15 Feb 2018 Planned primary completion date changed from 6 Sep 2018 to 1 Oct 2018.
- 09 Dec 2017 Results of Asian non-Japanese patients (n=26; as of 16 Jan 2017) presented at the 40th Annual San Antonio Breast Cancer Symposium
- 28 Jun 2017 Planned End Date changed from 12 Apr 2019 to 5 Oct 2018.