Description:
A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of
ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early
Breast Cancer
Title
- Brief Title: A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer
- Official Title: A Phase III Multi-center, Randomized, Open-label Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as an Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)
Clinical Trial IDs
- ORG STUDY ID:
CLEE011O12301C
- NCT ID:
NCT03701334
Conditions
Interventions
Drug | Synonyms | Arms |
---|
Ribociclib | | Ribociclib + Endocrine Therapy |
Purpose
A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of
ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early
Breast Cancer
Trial Arms
Name | Type | Description | Interventions |
---|
Ribociclib + Endocrine Therapy | Experimental | ribociclib 400 mg once daily on days 1-21 of a 28 day cycle followed by 7 days off" and endocrine therapy (ET) once daily continuously | |
Endocrine Therapy | Active Comparator | endocrine therapy (ET) only once daily continuously | |
Eligibility Criteria
Inclusion Criteria:
- Patient is ≥ 18 years-old at the time of PICF signature
- Patient is female with known menopausal status at the time of randomization or
initiation of adjuvant ET (whichever occurs earlier), or male.
- Patient with histologically confirmed unilateral primary invasive adenocarcinoma of
the breast with a date of initial cytologic or histologic diagnosis within 18 months
prior to randomization.
- Patient has breast cancer that is positive for ER and/or PgR
- Patient has HER2-negative breast cancer
- Patient has available archival tumor tissue from the surgical specimen
- Patient after surgical resection where tumor was removed completely, with the final
surgical specimen microscopic margins free from tumor, and belongs to one of the
following categories: anatomic stage group II or III
- If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according
to the institutional guidelines
- If indicated, patient has completed adjuvant radiotherapy according to the
institutional guidelines
- Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
- Patient has no contraindication for the adjuvant ET in the trial and is planned to be
treated with ET for 5 years
Exclusion Criteria:
- Patient has received any CDK4/6 inhibitor
- Patient has received prior treatment with tamoxifen, raloxifene or AIs for reduction
in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within
the last 2 years prior to randomization. Patient is concurrently using hormone
replacement therapy.
- Patient has received prior treatment with anthracyclines at cumulative doses of 450
mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin.
- Patient with a known hypersensitivity to any of the excipients of ribociclib and/or ET
- Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV
according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
- Patient is concurrently using other anti-neoplastic therapy with the exception of
adjuvant ET
- Patient has had major surgery, chemotherapy or radiotherapy within 14 days prior to
randomization
- Patient has not recovered from clinical and laboratory acute toxicities related to
prior anti-cancer therapies
- Patient has a concurrent invasive malignancy or a prior invasive malignancy whose
treatment was completed within 2 years before randomization
- Patient has known HIV infection, Hepatitis B or C infection
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization
abnormality
- Patient is currently receiving any of the following substances within 7 days before
randomization - Concomitant medications, herbal supplements, and/or fruits that are
known as strong inhibitors or inducers of CYP3A4/5 or Medications that have a narrow
therapeutic window and are predominantly metabolized through CYP3A4/5
- is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to
starting trial treatment
- Patient has impairment of GI function or GI disease that may significantly alter the
absorption of the oral trial treatments
- Patient has any other concurrent severe and/or uncontrolled medical condition that
would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate
patient participation in the clinical trial or compromise compliance with the protocol
- Participation in other studies involving investigational drug(s) within 30 days prior
to randomization or within 5 half-lives of the investigational drug(s) (whichever is
longer), or participation in any other type of medical research judged not to be
scientifically or medically compatible with this trial.
- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or
breast-feed during the trial
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | Invasive Disease-Free Survival |
Time Frame: | 44 months |
Safety Issue: | |
Description: | Invasive Disease-Free Survival for ribociclib + Endocrine Therapy versus Endocrine Therapy in patients with HR-positive, HER2-negative Early Breast Cancer using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator |
Secondary Outcome Measures
Measure: | Recurrence-free survival |
Time Frame: | 44 months |
Safety Issue: | |
Description: | using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials) |
Measure: | Distant disease-free survival |
Time Frame: | 44 months |
Safety Issue: | |
Description: | using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials) |
Measure: | Overall Survival |
Time Frame: | 91 months |
Safety Issue: | |
Description: | overall survival |
Measure: | Change from baseline in the global health status Quality of life scale score as assessed by EORTC QLQ-C30 |
Time Frame: | 44 months |
Safety Issue: | |
Description: | The EORTC QLQ-C30 contains functional scales, symptom scales, single items scale and a global health status/QoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
Measure: | Change from baseline in the physical functioning sub-scale score as assessed by EORTC QLQ-C30 |
Time Frame: | 44 months |
Safety Issue: | |
Description: | The EORTC QLQ-C30 contains functional scales, symptom scales, single items scale and a global health status/QoL scale. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. |
Measure: | PK parameter Ctrough and other applicable parameters for ribociclib |
Time Frame: | 44 months |
Safety Issue: | |
Description: | Pharmacokinetics of ribociclib when given in combination with Non-Steroidal Aromatase Inhibitor (and goserelin if applicable) |
Details
Phase: | Phase 3 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Novartis Pharmaceuticals |
Trial Keywords
- early breast cancer (EBC)
- HR+/HER2-
- adjuvant
- LEE011
- ribociclib
- CDK4/6 inhibitor
Last Updated
August 20, 2021