Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
Recruiting · NCT05827081 · Interventional (participants receive a specific treatment) · Lead sponsor: Novartis Pharmaceuticals
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
The purpose of this open-label, multicenter, phase IIIb, single-arm study is to characterize the efficacy and safety of the combination of ribociclib and standard adjuvant endocrine therapy (ET) on invasive breast cancer-free survival (iBCFS), in a close to clinical practice patient population with HR-positive (HR+), HER2-negative (HER2-), Anatomic Stage Group III, IIB, and a subset of Stage IIA Early Breast Cancer (EBC).
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Participant is an adult, male or female ≥ 18 years of age at the time of informed consent form signature (IC).
- Participant has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer (BC) based on the most recently analyzed tissue sample tested by a local laboratory prior to enrollment.
- Participant has HER2- BC defined as a negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing based on the most recently analyzed tissue sample.
- Participants may have already received any standard neoadjuvant and/or adjuvant ET, including tamoxifen or toremifene at the time of informed consent signature, but enrollment should occur within 36 months of prior ET start date and participants should have at least 3 years remaining of endocrine adjuvant therapy.
- For participants with prior ET treatment \> 12 months, restaging is highly recommended (unless contradictory to local regulations) to rule out disease recurrence prior to enrollment.
- The number of participants with prior ET between 12 and 36 months will be capped at 30%. The cap will not apply to Black or African American participants.
- Participant has no contraindication to receive adjuvant ET in the study.
- Participant 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 III, or
- Anatomic Stage Group IIB, or
- A subset of Anatomic Stage Group IIA.
- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1 or 2.
- Participant has adequate bone marrow and organ function.
- ECG values assessed by KardiaMobile-6L device, or standard 12-lead ECG per local investigator where KardiaMobile-6L cannot be used, as:
- QTcF interval at Screening \< 450 msec (QT interval using Fridericia's correction).
- Mean resting heart rate 50-99 beats per minute (determined from the ECG).
- Key
Exclusion criteria
- Participant with distant metastases of BC beyond regional lymph nodes (Stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
- Participant is concurrently using other antineoplastic therapy with the exception of adjuvant ET.
- Participant has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate participant participation in the clinical study or compromise compliance with the protocol, or limit life expectancy to ≤5 years.
- Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.
- Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial.
- Women of child-bearing potential (CBP), defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception while taking study treatment and for 21 days after stopping the treatment.
- ther inclusion/exclusion criteria may apply
Where it is running
60 locations listed across 38 US states.
- Central Alabama Research - Birmingham, Alabama, United States
- Alaska Oncology and Hematology LLC - Anchorage, Alaska, United States
- Western Reg MC-COH Phoenix - Goodyear, Arizona, United States
- CARTI Cancer Center - Little Rock, Arkansas, United States
- Beverly Hills Cancer Center - Beverly Hills, California, United States
- Onco Inst of Hope and Innovation - Cerritos, California, United States
- City of Hope National Medical - Duarte, California, United States
- Providence Medical Foundation - Fullerton, California, United States
- Los Angeles Cancer Network Good Samaritan - Los Angeles, California, United States
- El Camino Hospital - Mountain View, California, United States
- Palo Alto Medical Foundation - Mountain View, California, United States
- UC Irvine Medical Center - Orange, California, United States
- Sutter Inst Medical Research - Sacramento, California, United States
- School Of Medicine - Sacramento, California, United States
- Sharp Rees Stealy Medical Group Inc - San Diego, California, United States
- AdventHealth Medical Group Hematology and Oncology - Denver, Colorado, United States
- Rocky Mountain Cancer Centers - Denver, Colorado, United States
- Georgetown University Lombardi Cancer Center - Washington D.C., District of Columbia, United States
- Medstar Washington Hospital Center - Washington D.C., District of Columbia, United States
- AdventHealth Altamonte Springs - Altamonte Springs, Florida, United States
- Holy Cross Health - Fort Lauderdale, Florida, United States
- Hialeah Hospital - Hialeah, Florida, United States
- Memorial Cancer Institute - Hollywood, Florida, United States
- Jupiter Medical Center - Jupiter, Florida, United States
- Ocala Research Institute, Inc - Ocala, Florida, United States
- University Cancer and Blood Center LLC - Athens, Georgia, United States
- Summit Cancer Care PC - Savannah, Georgia, United States
- Hawaii Cancer Care - Honolulu, Hawaii, United States
- Affiliated Oncologists IL - Chicago, Illinois, United States
- Hope And Healing Care - Hinsdale, Illinois, United States
- Midwestern Reg MC COH Chicago - Zion, Illinois, United States
- Investigative Clinical R of Indiana - Indianapolis, Indiana, United States
- University of Iowa Health Care - Waukee, Iowa, United States
- University of Kansas Cancer Center - Westwood, Kansas, United States
- Cancer Center of Kansas - Wichita, Kansas, United States
- Willis-Knighton Cancer Center - Shreveport, Louisiana, United States
- Mercy Medical Center - Baltimore, Maryland, United States
- Maryland Oncology Hematology P A - Silver Spring, Maryland, United States
- Boston Medical Center - Boston, Massachusetts, United States
- Dana Farber Cancer Institute - Boston, Massachusetts, United States
- Dana Farber Brigham Women Cancer - Milford, Massachusetts, United States
- Minnesota Oncology Hematology P A - Minneapolis, Minnesota, United States
- Allina Hlth Cancer Inst Minneapolis - Minneapolis, Minnesota, United States
- Jackson Oncology Associates - Jackson, Mississippi, United States
- HCA Midwest Division - Kansas City, Missouri, United States
- WA Uni School Of Med - St Louis, Missouri, United States
- Intermountain Healthcare - Billings, Montana, United States
- Nebraska Cancer Specialists - Omaha, Nebraska, United States
- Renown Regional Medical Center - Reno, Nevada, United States
- Cancer Care Specialists - Reno, Nevada, United States
- MD Anderson Cancer Center At Cooper - Camden, New Jersey, United States
- Summit Health - Florham Park, New Jersey, United States
- The Valley Hospital - Ridgewood, New Jersey, United States
- Presbyterian Medical Group - Albuquerque, New Mexico, United States
- Queens Cancer Center of Queens Hospital - Jamaica, New York, United States
- Optum Health - Lake Success, New York, United States
- Mount Sinai School of Medicine - New York, New York, United States
- Duke Cancer Network - Durham, North Carolina, United States
- Cone Health Cancer Center - Greensboro, North Carolina, United States
- Sanford Research USD Fargo - Fargo, North Dakota, United States
Showing 60 of 229 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →