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Adjuvant Ribociclib With Endocrine Therapy in Hormone Receptor+/HER2- High Risk Early Breast Cancer (EarLEE-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03078751
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : June 9, 2020
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This is 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

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Ribociclib Drug: Adjuvant endocrine therapy Phase 2

Detailed Description:
While adjuvant endocrine therapy (ET) is effective in reducing risk of recurrence in patients with hormone receptor (HR)-positive early breast cancer (EBC), recurrences are still common, especially in patients with unfavorable clinical, pathological and/or molecular features. Ribociclib, a CDK4/6 inhibitor, demonstrated clinical efficacy with tolerable toxicity when added to ET in patients with HR-positive, HER2-negative advanced breast cancer. The purpose of this study is to evaluate the preliminary safety and tolerability of ribociclib to standard adjuvant ET in patients with HR+, HER2- high-risk EBC.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Ribociclib

Arm Intervention/treatment
Experimental: Ribociclib + adjuvant endocrine therapy
Ribociclib in combination with standard adjuvant endocrine therapy
Drug: Ribociclib

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.

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03078751

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Sponsors and Collaborators
Novartis Pharmaceuticals
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Publications of Results:
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Responsible Party: Novartis Pharmaceuticals Identifier: NCT03078751    
Other Study ID Numbers: CLEE011G2301
2014-001795-53 ( EudraCT Number )
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: June 9, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Hormone receptor-positive
Estrogen and/or progesterone receptor-positive
High risk early breast cancer
CDK4/6 inhibitor
Endocrine therapy
Phase II
Breast carcinoma
Breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases