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A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

NCT03701334

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

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 3

Trial Eligibility

Document

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-negartive Early Breast Cancer (New Adjuvant TriAl With Ribociclib [LEE011]: NATALEE)

Clinical Trial IDs

  • ORG STUDY ID: CLEE011O12301C
  • NCT ID: NCT03701334

Conditions

  • Early Breast Cancer

Interventions

DrugSynonymsArms
RibociclibRibociclib + 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

NameTypeDescriptionInterventions
Ribociclib + Endocrine TherapyExperimentalribociclib 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
  • Ribociclib
Endocrine TherapyActive Comparatorendocrine therapy (ET) only once daily continuously

    Eligibility Criteria

            Inclusion
    
              -  Patient is ≥ 18 years-old at the time of PICF signature
    
              -  Patient is female with known menopausal status at the time of PICF signature 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 who 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 no contraindication for the adjuvant ET in the trial and is planned to be
                 treated with ET for 5 years
    
            Exclusion
    
              -  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 PICF signature
    
              -  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 PICF signature
    
              -  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
    
              -  Patient participated in another interventional study and received treatment with an
                 investigational product (or used an investigational device) within 30 days prior to
                 randomization or within 5 half-lives of the investigational product, whichever is
                 longer.
    
              -  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:3.5 years
    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:3.5 years
    Safety Issue:
    Description:using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials)
    Measure:Distant disease-free survival
    Time Frame:3.5 years
    Safety Issue:
    Description:using STEEP criteria (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials)
    Measure:Overall Survival
    Time Frame:7.5 years
    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:3.5 years
    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:3.5 years
    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 Cmax for ribociclib
    Time Frame:3.5 years
    Safety Issue:
    Description:Pharmacokinetics of ribociclib when given in combination with Non-Steroidal Aromatase Inhibitor (and goserelin if applicable)
    Measure:PK parameter Tmax for ribociclib
    Time Frame:3.5 years
    Safety Issue:
    Description:Pharmacokinetics of ribociclib when given in combination with Non-Steroidal Aromatase inhibitor (and goserelin if applicable)
    Measure:PK parameter AUC0-24 for ribociclib
    Time Frame:3.5 years
    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:Not yet recruiting
    Lead Sponsor:Novartis Pharmaceuticals

    Trial Keywords

    • early breast cancer (EBC)
    • HR+/HER2-
    • adjuvant
    • LEE011
    • ribociclib
    • CDK4/6 inhibitor

    Last Updated