A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+ / HER2- Early Breast Cancer
Trial 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
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
Alabama
Birmingham
University of Alabama at Birmingham Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Ahmed Elkhanany
Phone: 205-934-7825
Email:
aelkhanany@uabmc.edu
California
Los Angeles
Translational Research In Oncology - US Inc
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Kyanne O'Bryant
Phone: 310-794-6500
Email:
kobryant@mednet.ucla.edu
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ACTIVE
San Francisco
UCSF Medical Center-Mount Zion
Status: ACTIVE
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email:
cancertrials@ucsf.edu
Colorado
Denver
University of Colorado
Status: ACTIVE
Connecticut
New Haven
Yale University
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Florida
Miami
University of Miami Miller School of Medicine-Sylvester Cancer Center
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Georgia
Atlanta
Emory University Hospital / Winship Cancer Institute
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Emory University Hospital Midtown
Status: ACTIVE
Kansas
Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Rebecca P Colgan
Phone: 913-588-7549
Email:
rcolgan@kumc.edu
Massachusetts
Boston
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Michigan
Ann Arbor
University of Michigan Comprehensive Cancer Center
Status: ACTIVE
New York
New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ACTIVE
Texas
Houston
M D Anderson Cancer Center
Status: ACTIVE
Washington
Seattle
Fred Hutch / University of Washington Cancer Consortium
Status: ACTIVE
Wisconsin
Madison
University of Wisconsin Hospital and Clinics
Status: TEMPORARILY_CLOSED_TO_ACCRUAL
Trial Phase Phase III
Trial Type Treatment
Lead Organization
Novartis Pharmaceuticals Corporation
- Primary ID CLEE011O12301C
- Secondary IDs NCI-2019-01526
- Clinicaltrials.gov ID NCT03701334