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

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Ribociclib + Endocrine Therapy
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
  • Drug: Ribociclib
    Ribociclib + ET
  • Other: Endocrine Therapy
    Endocrine Therapy (ET)
Active Comparator
Endocrine Therapy
endocrine therapy (ET) only once daily continuously
  • Drug: Ribociclib
    Ribociclib + ET
  • Other: Endocrine Therapy
    Endocrine Therapy (ET)

Recruiting Locations

University of Alabama at Birmingham/ Kirklin Clinic
Birmingham, Alabama 35294-0006

More Details

Status
Recruiting
Sponsor
Novartis Pharmaceuticals

Study Contact

Novartis Pharmaceuticals
1-888-669-6682
novartis.email@novartis.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.