Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer (EarLEE-1)
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|ClinicalTrials.gov Identifier: NCT03078751|
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : June 9, 2020
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Ribociclib Drug: Adjuvant endocrine therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The trial used to be a parallel design, it has been amended to a single arm trial.|
|Masking:||None (Open Label)|
|Official Title:||An Open Label, Multi-center Protocol for U.S. Patients Enrolled in a Study of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative, High Risk Early Breast Cancer|
|Actual Study Start Date :||June 20, 2017|
|Actual Primary Completion Date :||March 9, 2020|
|Actual Study Completion Date :||March 9, 2020|
Experimental: Ribociclib + adjuvant endocrine therapy
Ribociclib in combination with standard adjuvant endocrine therapy
Ribociclib 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months).
Ribociclib will be supplied in the form of 200 mg tablets.
Other Name: LEE011
Drug: Adjuvant endocrine therapy
Letrozole 2.5 mg daily, or anastrozole 1 mg daily, or exemestane 25 mg daily for a total duration of at least 60 months. In premenopausal women, adjuvant endocrine therapy will include GnRH agonist administered every 28 days.
- Preliminary safety and tolerability of the ribociclib + ET in patients that were randomized to ribociclib + ET prior to the early closure of enrollment. [ Time Frame: Up to 26 months ]Tolerability and Safety of the treatment regimen based on frequency and severity of AEs, laboratory and ECG abnormalities
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03078751
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|