Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer
EarLEE-1
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
2 other identifiers
interventional
54
1 country
33
Brief Summary
This was an open label, multi-center protocol for U.S. patients enrolled in the study of ribociclib with endocrine therapy as an adjuvant treatment in patients with hormone receptor-positive, HER2-negative, high risk early breast cancer
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 breast-cancer
Started Jun 2017
33 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2017
CompletedFirst Posted
Study publicly available on registry
March 13, 2017
CompletedStudy Start
First participant enrolled
June 20, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 9, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 9, 2020
CompletedResults Posted
Study results publicly available
January 15, 2021
CompletedOctober 11, 2021
October 1, 2021
2.7 years
February 27, 2017
December 21, 2020
October 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants With Adverse Events and Serious Adverse Events
These are the number of participants who had adverse events or serious adverse events regardless of whether is was suspected to be drug-related or not
Up to 26 months
Percentage of Participants With Adverse Events and Serious Adverse Events
These are the percentage of participants that had adverse events or serious adverse events regardless of whether is was suspected to be drug-related or not
Up to 26 months
Study Arms (2)
Ribociclib + adjuvant endocrine therapy (ET)
EXPERIMENTALPatients in this arm took Ribociclib in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen (Tamoxifen no longer permitted after protocol amendment 2)
Placebo + adjuvant endocrine therapy (ET)
PLACEBO COMPARATORPatients in this arm took Placebo in combination with standard adjuvant endocrine therapy. ET was one of these 4: Letrozole, Anastrozole, Exemestane, Tamoxifen
Interventions
Ribociclib 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months). Ribociclib was supplied in the form of 200 mg film-coated tablets taken by mouth.
Letrozole 2.5 mg by mouth daily, or anastrozole 1 mg by mouth daily, exemestane 25 mg by mouth daily, tamoxifen 20 mg by mouth daily, for a total duration of at least 60 months. In premenopausal women, a GnRH agonist administered every 28 days.
Placebo 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months). Placebo was supplied in the form of 200 mg film-coated tablets taken by mouth.
Eligibility Criteria
You may qualify if:
- Histologically confirmed unilateral primary invasive adenocarcinoma of the breast
- Estrogen receptor-positive and/or progesterone receptor-positive, HER2-negative breast cancer
- Patient is after surgical resection of the tumor where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor and with available archival tumor tissue from the surgical specimen
- Patient who received adjuvant chemotherapy and have AJCC 8th edition Prognostic Stage Group III tumor; or patient who received neoadjuvant chemotherapy and have 1 or more ipsilateral axillary lymph nodes with residual tumor metastases greater than 2.0 mm in lymph node(-s) and residual tumor greater than 10.0 mm in breast tissue
- Patient has completed multi-agent adjuvant or neoadjuvant chemotherapy of ≥ 4 cycles or ≥ 12 weeks which included taxanes prior to screening
- Patient has completed adjuvant radiotherapy (if indicated) prior to screening
- Patient may already have initiated adjuvant endocrine therapy (ET) at the time of randomization, but randomization must take place within 52 weeks of date of initial histological diagnosis of breast cancer and within 12 weeks of initiating ET
- ECOG Performance Status 0 or 1
- Adequate bone marrow and organ function
- Sodium, potassium, phosphorus, magnesium and total calcium laboratory values within normal limits
- QTcF interval \< 450 msec and mean resting heart rate 50-90 bpm
You may not qualify if:
- Prior treatment with CDK4/6 inhibitor
- Prior treatment with tamoxifen, raloxifen or aromatase inhibitors for reduction in risk (chemoprevention) of breast cancer and/or treatment for osteoporosis within last 2 years
- Prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin or 900 mg/m² or more for epirubicin
- Distant metastases of breast cancer beyond regional lymph nodes
- Patient has not recovered from clinical and laboratory acute toxicities of chemotherapy, radiotherapy and surgery
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality, or clinically significant cardiac arrhythmias
- Uncontrolled hypertension with systolic blood pressure \>160 mmHg
- Patient is currently receiving any of the prohibited substances that cannot be discontinued 7 days prior to Cycle 1 Day 1: concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5; medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5; systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment; concomitant medications with a known risk to prolong the QT interval and/or known to cause torsades de points that cannot be discontinued or replaced by safe alternative medication.
- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the study
- Women of child-bearing potential unless they are using highly effective methods of contraception during the study treatment and for 21 days after stopping the study treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (33)
Arizona Oncology Associates PC- HAL
Tucson, Arizona, 85704, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
CBCC Global Research
Bakersfield, California, 93309, United States
University of California - Los Angeles
Los Angeles, California, 90024, United States
Ventura County Hematology and Oncology
Oxnard, California, 93030, United States
TRIO - Torrance Health Association
Redondo Beach, California, 90277, United States
Innovative Clinical Research Institute
Whittier, California, 90603, United States
Rocky Mountain Cancer Centers Regulatory
Denver, Colorado, 80218, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360, United States
Florida Cancer Specialists South Region
Fort Myers, Florida, 33916, United States
Memorial Regional Hospital
Hollywood, Florida, 33021, United States
Hematology Oncology Associates of the Treasure Coast
Port Saint Lucie, Florida, 34952, United States
Florida Cancer Specialists - North Florida Cancer Specialist N
St. Petersburg, Florida, 33705, United States
Northside Hospital Central Research Dept.
Atlanta, Georgia, 30342, United States
Summit Cancer Care, PC
Savannah, Georgia, 31405, United States
Health Midwest Ventures Group, Inc d/b/a HCA MidAmerica Div.
Leawood, Kansas, 66209, United States
Maryland Oncology Hematology P A
Silver Spring, Maryland, 20904, United States
Saint Luke's Hospital of Kansas City
Kansas City, Missouri, 64111, United States
Saint Barnabas Medical Center 2nd Floor East Wing
Livingston, New Jersey, 07039, United States
Pro Health Care Associates
New Hyde Park, New York, 11042, United States
The Presbyterian Hospital
Charlotte, North Carolina, 28210, United States
Tennessee Oncology, PLLC
Chattanooga, Tennessee, 37404, United States
The West Clinic
Germantown, Tennessee, 38138, United States
SCRI - Tennessee Oncology
Nashville, Tennessee, 37203, United States
Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology P A Texas Oncology - Houston
Dallas, Texas, 75251, United States
Millennium Oncology
Houston, Texas, 77090, United States
Cancer Care Network of South Texas
San Antonio, Texas, 78258, United States
Texas Oncology PA - Tyler
Tyler, Texas, 75702, United States
Fairfax Northern Virginia Hem/Onc
Fairfax, Virginia, 22031, United States
Multicare Institute for Research and Innovation
Tacoma, Washington, 98405, United States
Northwest Medical Specialties
Tacoma, Washington, 98405, United States
Wenatchee Valley Hospital and Clinics
Wenatchee, Washington, 98801, United States
Related Publications (2)
Hudis CA, Barlow WE, Costantino JP, Gray RJ, Pritchard KI, Chapman JA, Sparano JA, Hunsberger S, Enos RA, Gelber RD, Zujewski JA. Proposal for standardized definitions for efficacy end points in adjuvant breast cancer trials: the STEEP system. J Clin Oncol. 2007 May 20;25(15):2127-32. doi: 10.1200/JCO.2006.10.3523.
PMID: 17513820RESULTHortobagyi GN, Connolly JL, D'Orsi CJ, et al (2017). Breast. From AJCC Cancer Staging Manual 8th ed. By Amin MB, Edge S, Greene FL, et al. Springer
RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The trial used to be a placebo-controlled, blinded trial. It was amended to an open-label trial after protocol amendment 2.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 27, 2017
First Posted
March 13, 2017
Study Start
June 20, 2017
Primary Completion
March 9, 2020
Study Completion
March 9, 2020
Last Updated
October 11, 2021
Results First Posted
January 15, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent expert panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the triasl in line with applicable laws and regulations. This trial data will be available according to the process described on www.clinicalstudydatarequest.com.