Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
Purpose
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).
Condition
- Early Breast Cancer
Eligibility
- Eligible Ages
- Between 18 Years and 100 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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).
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. Other inclusion/exclusion criteria may apply
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Ribociclib + endocrine therapy |
Participants will receive ribociclib 400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with daily endocrine therapy (ET) for 36 months (approximately 39 cycles). ET consists of: - For postmenopausal women: letrozole 2.5 mg orally once daily continuously, anastrozole 1 mg orally once daily continuously, or exemestane 25 mg once daily continuously. - For pre/perimenopausal women, and men: letrozole 2.5 mg orally once daily continuously, anastrozole 1 mg orally once daily continuously, or exemestane 25 mg once daily continuously, combined with goserelin subcutaneously (at 3.6 mg once every 4 weeks if the one-month depot formulation is used or at 10.8 mg once every 3 months if the three-month depot formulation is used) or leuprolide subcutaneously (at 3.75 mg once every 4 weeks if the one-month depot formulation is used or at 11.25 mg once every 3 months if the three-month depot formulation is used) |
|
Recruiting Locations
Central Alabama Research
Birmingham, Alabama 35209
Birmingham, Alabama 35209
Alaska Oncology and Hematology LLC
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Western Reg MC-COH Phoenix
Goodyear, Arizona 85338
Goodyear, Arizona 85338
CARTI Cancer Center
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
Beverly Hills Cancer Center
Beverly Hills, California 90211
Beverly Hills, California 90211
Onco Inst of Hope and Innovation
Cerritos, California 90703
Cerritos, California 90703
City of Hope National Medical
Duarte, California 91010
Duarte, California 91010
Providence Medical Foundation
Fullerton, California 92835
Fullerton, California 92835
Los Angeles Cancer Network Good Samaritan
Los Angeles, California 90017
Los Angeles, California 90017
Palo Alto Medical Foundation
Mountain View, California 94040
Mountain View, California 94040
UC Irvine Medical Center
Orange, California 92868
Orange, California 92868
Sutter Inst Medical Research
Sacramento, California 95816-5199
Sacramento, California 95816-5199
School Of Medicine
Sacramento, California 95817
Sacramento, California 95817
AdventHealth Medical Group Hematology and Oncology
Denver, Colorado 80210
Denver, Colorado 80210
Rocky Mountain Cancer Centers
Denver, Colorado 80218
Denver, Colorado 80218
Georgetown University Lombardi Cancer Center
Washington D.C., District of Columbia 20007-2197
Washington D.C., District of Columbia 20007-2197
Washington Hospital Center
Washington D.C., District of Columbia 20010
Washington D.C., District of Columbia 20010
AdventHealth Altamonte Springs
Altamonte Springs, Florida 32701
Altamonte Springs, Florida 32701
Holy Cross Health
Fort Lauderdale, Florida 33308
Fort Lauderdale, Florida 33308
Jupiter Medical Center
Jupiter, Florida 33458
Jupiter, Florida 33458
Ocala Research Institute, Inc
Ocala, Florida 34474
Ocala, Florida 34474
University Cancer and Blood Center LLC
Athens, Georgia 30607
Athens, Georgia 30607
Summit Cancer Care PC
Savannah, Georgia 31405
Savannah, Georgia 31405
Hawaii Cancer Care
Honolulu, Hawaii 96813
Honolulu, Hawaii 96813
Affiliated Oncologists IL
Chicago, Illinois 60415
Chicago, Illinois 60415
Midwestern Reg MC COH Chicago
Zion, Illinois 60099
Zion, Illinois 60099
Investigative Clinical R of Indiana
Indianapolis, Indiana 46260
Indianapolis, Indiana 46260
Cancer Center of Kansas
Wichita, Kansas 67214-3728
Wichita, Kansas 67214-3728
Mercy Medical Center
Baltimore, Maryland 21202
Baltimore, Maryland 21202
Maryland Oncology Hematology P A
Silver Spring, Maryland 20904
Silver Spring, Maryland 20904
Boston Medical Center
Boston, Massachusetts 02118
Boston, Massachusetts 02118
Dana Farber Cancer Institute
Boston, Massachusetts 02215
Boston, Massachusetts 02215
Dana Farber Brigham Women Cancer
Milford, Massachusetts 01757
Milford, Massachusetts 01757
Minnesota Oncology Hematology P A
Minneapolis, Minnesota 55404
Minneapolis, Minnesota 55404
Allina Hlth Cancer Inst Minneapolis
Minneapolis, Minnesota 55407
Minneapolis, Minnesota 55407
Jackson Oncology Associates
Jackson, Mississippi 39202
Jackson, Mississippi 39202
HCA Midwest Division
Kansas City, Missouri 64132
Kansas City, Missouri 64132
WA Uni School Of Med
St Louis, Missouri 63110
St Louis, Missouri 63110
Nebraska Cancer Specialists
Omaha, Nebraska 68154
Omaha, Nebraska 68154
MD Anderson Cancer Center At Cooper
Camden, New Jersey 08103
Camden, New Jersey 08103
Summit Health
Florham Park, New Jersey 07932
Florham Park, New Jersey 07932
Presbyterian Medical Group
Albuquerque, New Mexico 87110
Albuquerque, New Mexico 87110
Queens Cancer Center of Queens Hospital
Jamaica, New York 11432
Jamaica, New York 11432
Optum Health
Lake Success, New York 11042
Lake Success, New York 11042
Mount Sinai School of Medicine
New York, New York 10029
New York, New York 10029
Cone Health Cancer Center
Greensboro, North Carolina 27403
Greensboro, North Carolina 27403
Sanford Research USD Fargo
Fargo, North Dakota 58122
Fargo, North Dakota 58122
Good Samaritan Regional Medical Center
Corvallis, Oregon 97330
Corvallis, Oregon 97330
Oncology Associates of Oregon PC
Eugene, Oregon 97401-8122
Eugene, Oregon 97401-8122
Northwest Cancer Specialists
Portland, Oregon 97210
Portland, Oregon 97210
Consultants In Med Onco And Hema
Drexel Hill, Pennsylvania 19026
Drexel Hill, Pennsylvania 19026
Univ of Pittsburg Med Ctr Pinnacle
Harrisburg, Pennsylvania 17109
Harrisburg, Pennsylvania 17109
Allegheny Health Network
Pittsburgh, Pennsylvania 15212
Pittsburgh, Pennsylvania 15212
Rhode Island Hospital
Providence, Rhode Island 02903
Providence, Rhode Island 02903
Bon Secours St Francis Cancer Center
Greenville, South Carolina 29607
Greenville, South Carolina 29607
Lexington Medical Center
West Columbia, South Carolina 29169
West Columbia, South Carolina 29169
Regional Medical Oncology NC
Wilson, South Carolina 27893
Wilson, South Carolina 27893
Sanford USD Medical Center
Sioux Falls, South Dakota 57104
Sioux Falls, South Dakota 57104
Sarah Cannon Research Institute
Nashville, Tennessee 37203
Nashville, Tennessee 37203
Kelsey Seybold Clinic
Houston, Texas 77025
Houston, Texas 77025
University of Texas
Houston, Texas 77030-4099
Houston, Texas 77030-4099
Texas Oncology P A Plano East
Plano, Texas 75075
Plano, Texas 75075
Texas Oncology PA Tyler
Tyler, Texas 75702
Tyler, Texas 75702
Bon Secours Virginia Health System
Midlothian, Virginia 23114
Midlothian, Virginia 23114
Virginia Oncology Associates
Norfolk, Virginia 23502
Norfolk, Virginia 23502
Kadlec Clinic Hematology and Onco
Kennewick, Washington 99336
Kennewick, Washington 99336
Providence Regional Cancer System
Lacey, Washington 98503
Lacey, Washington 98503
Valley Medical Center Research
Renton, Washington 98055
Renton, Washington 98055
Northwest Medical Specialties
Tacoma, Washington 98405
Tacoma, Washington 98405
Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Milwaukee, Wisconsin 53226
Pan Oncology
Rio Piedras, Puerto Rico 00935
Rio Piedras, Puerto Rico 00935
More Details
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
Detailed Description
The study consists of Screening, Treatment, and Follow-up periods. - Treatment Period: all participants who complete screening will receive ribociclib 400 mg orally once daily on days 1 to 21 of a 28-day cycle, in combination with daily ET for 36 months (approximately 39 cycles) from the date of first dose. The Treatment Period starts when the patient receives their first dose of ribociclib and ends at the time of the 30-day Safety Follow-up. All treated participants should have a Safety Follow-up call conducted 30 days after the last dose of study treatment. - Follow-up period: participants will be followed from 30 days after study treatment (i.e., ribociclib) completion/discontinuation (i.e. 30-day Safety Follow-up) until death, withdrawal of consent, lost to follow-up, or until 48 months after the last participant has received their first dose of study treatment (i.e. End of Study [EOS]), whichever occurs first.