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

Status: Active


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

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 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 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 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

Locations & Contacts


Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Kyanne O'Bryant
Phone: 310-794-6500
Email: kobryant@mednet.ucla.edu
San Francisco
UCSF Medical Center-Mount Zion
Status: Approved
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email: cancertrials@ucsf.edu


University of Colorado
Status: Active
Name Not Available


University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: Active
Name Not Available


Emory University Hospital / Winship Cancer Institute
Status: Active
Name Not Available
Emory University Hospital Midtown
Status: Active
Name Not Available


Massachusetts General Hospital Cancer Center
Status: Active
Name Not Available


University of Minnesota / Masonic Cancer Center
Status: Active
Name Not Available

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: Active
Name Not Available


Fred Hutch / University of Washington Cancer Consortium
Status: Active
Name Not Available


University of Wisconsin Hospital and Clinics
Status: Active
Name Not Available

Trial Phase & Type

Trial Phase

Phase III

Trial Type


Lead Organization

Lead Organization
Novartis Pharmaceuticals Corporation

Trial IDs

Primary ID CLEE011O12301C
Secondary IDs NCI-2019-01526
Clinicaltrials.gov ID NCT03701334