NCT02333370

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 88 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the Phase Ib is to: 1. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and anti-tumor activity data in Asian non-Japanese patients 2. determine the recommended dose of LEE011 in combination with a standard dose of letrozole as well as to provide additional safety and activity data in Japanese patients 3. evaluate the safety and anti-tumor activity of LEE011 at the RP2D established in the dose escalation part in combination with a standard dose of letrozole, fulvestrant or tamoxifen plus goserelin in Japanese patients.

Conditions

• Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

Interventions

Type	Name	Description
DRUG	LEE011	LEE011 as 50 mg and 200 mg hard gelatin oral capsules as individual patient supply packaged in bottles. LEE011 will be taken QD - days 1-21 of each 28 days cycle.
DRUG	Letrozole	25mg
DRUG	Tamoxifen	20 mg
DRUG	Fulvestrant	500 mg
DRUG	goserelin

Timeline

• Start date: 2015-02-04
• Primary completion: 2022-09-29
• Completion: 2022-09-29
• First posted: 2015-01-07
• Last updated: 2023-06-08

Locations

15 sites across 3 countries: Hong Kong, Japan, Singapore