Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
NCT ID: NCT05827081
Last Updated: 2026-02-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
1400 participants
INTERVENTIONAL
2024-02-28
2030-09-20
Brief Summary
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Detailed Description
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* 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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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)
Ribociclib
Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest
Letrozole
Letrozole 2.5 mg orally once daily continuously
Ansastrozole
Anastrozole 1 mg orally once daily continuously.
Goserelin
Goserelin administered 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
Leuprolide
Leuprolide administered 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
Exemestane
Exemestane 25 mg once daily continuously
Interventions
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Ribociclib
Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest
Letrozole
Letrozole 2.5 mg orally once daily continuously
Ansastrozole
Anastrozole 1 mg orally once daily continuously.
Goserelin
Goserelin administered 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
Leuprolide
Leuprolide administered 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
Exemestane
Exemestane 25 mg once daily continuously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
100 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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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
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
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
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Washington Hospital Center
Washington D.C., District of Columbia, United States
Holy Cross Health
Fort Lauderdale, Florida, United States
Memorial Cancer Institute
Hollywood, Florida, United States
Ocala Research Institute, Inc
Ocala, Florida, United States
Summit Cancer Care PC
Savannah, Georgia, 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
Minnesota Oncology Hematology P A
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
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
Clinical Research Alliance
Lake Success, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Cone Health Cancer Center
Greensboro, North Carolina, United States
Oncology Associates of Oregon PC
Eugene, Oregon, United States
Northwest Cancer Specialists
Portland, Oregon, United States
Oregon Oncology Specialists Salem
Salem, Oregon, United States
Consultants In Med Onco And Hema
Drexel Hill, Pennsylvania, United States
Univ of Pittsburg Med Ctr Pinnacle
Harrisburg, Pennsylvania, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Sanford USD Medical Center
Sioux Falls, South Dakota, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
El Paso Texas Oncology
El Paso, Texas, United States
University of Texas
Houston, Texas, United States
Texas Oncology P A Plano East
Plano, Texas, United States
Texas Oncology PA Tyler
Tyler, Texas, United States
Bon Secours Virginia Health System
Midlothian, Virginia, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
Providence Regional Cancer System
Lacey, Washington, United States
Northwest Medical Specialties
Tacoma, Washington, United States
Novartis Investigative Site
Gateshead, New South Wales, Australia
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Tiwi, Northern Territory, Australia
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Clayton, Victoria, Australia
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East Melbourne, Victoria, Australia
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Victoria, British Columbia, Canada
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Halifax, Nova Scotia, Canada
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Oakville, Ontario, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Beijing, Beijing Municipality, China
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Guangzhou, Guangdong, China
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Harbin, Heilongjiang, China
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Zhengzhou, Henan, China
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Zhengzhou, Henan, China
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Nanjing, Jiangsu, China
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Nanchang, Jiangxi, China
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Changchun, Jilin, China
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Jinan, Shandong, China
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Jinan, Shandong, China
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Jining, Shandong, China
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Chengdu, Sichuan, China
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Chengdu, Sichuan, China
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Ürümqi, Xinjiang, China
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Hangzhou, Zhejiang, China
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Hangzhou, Zhejiang, China
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Wenzhou, Zhejiang, China
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Beijing, , China
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Beijing, , China
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Guangzhou, , China
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Qingdao, , China
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Shanghai, , China
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Shijiazhuang, , China
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Tianjin, , China
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Freiburg im Breisgau, Baden-Wurttemberg, Germany
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Munich, Bavaria, Germany
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Regensburg, Bavaria, Germany
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Weiden in Der Oberpfalz, Bavaria, Germany
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Langen, Hesse, Germany
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Hildesheim, Lower Saxony, Germany
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Bergisch Gladbach, North Rhine-Westphalia, Germany
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Bielefeld, North Rhine-Westphalia, Germany
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Düsseldorf, North Rhine-Westphalia, Germany
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Essen, North Rhine-Westphalia, Germany
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Mönchengladbach, North Rhine-Westphalia, Germany
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Velbert, North Rhine-Westphalia, Germany
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Dresden, Saxony, Germany
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Lübeck, Schleswig-Holstein, Germany
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Augsburg, , Germany
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Augsburg, , Germany
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Berlin, , Germany
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Berlin, , Germany
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Bottrop, , Germany
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Böblingen, , Germany
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Dessau, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Hamburg, , Germany
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Kiel, , Germany
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Leipzig, , Germany
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Mainz, , Germany
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München, , Germany
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Ravensburg, , Germany
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Hong Kong, , Hong Kong
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Kowloon, , Hong Kong
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Tuenmen, , Hong Kong
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Hyderabad, Andhra Pradesh, India
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Bangalore, Karnataka, India
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Mumbai, Maharashtra, India
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Nashik, Maharasthra, India
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New Delhi, National Capital Territory of Delhi, India
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Bhubaneshwar, Odisha, India
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Chennai, Tamil Nadu, India
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Kolkata, West Bengal, India
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Ahmedabad, , India
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Beersheba, , Israel
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Petah Tikva, , Israel
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Ramat Gan, , Israel
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Tel Aviv, , Israel
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Alc Cuahutemoc, Mexico City, Mexico
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Tlalpan, Mexico City, Mexico
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Monterrey, Nuevo León, Mexico
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Coimbra, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Porto, , Portugal
Pan Oncology
Rio Piedras, , Puerto Rico
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Bundang Gu, Gyeonggi-do, South Korea
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Gyeonggi-do, Korea, South Korea
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Incheon, Korea, South Korea
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Seoul, Korea, South Korea
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Seoul, Korea, South Korea
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Seoul, Yangcheon Gu, South Korea
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Seongnam Gyeonggi, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Hualien City, , Taiwan
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Kaohsiung City, , Taiwan
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Tainan, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Sakarya, Adapazari, Turkey (Türkiye)
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Ankara, Bilkent-Cankaya, Turkey (Türkiye)
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Istanbul, Fatih, Turkey (Türkiye)
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Istanbul, Kadikoy, Turkey (Türkiye)
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Izmir, Karsiyaka, Turkey (Türkiye)
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Denizli, Kinikli, Turkey (Türkiye)
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Antalya, Konyaalti, Turkey (Türkiye)
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Istanbul, Sariyer, Turkey (Türkiye)
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Ankara, Sihhiye-Altindag, Turkey (Türkiye)
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Diyarbakır, Sur, Turkey (Türkiye)
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Istanbul, Uskudar, Turkey (Türkiye)
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Ankara, Yenimahalle, Turkey (Türkiye)
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Ankara, Yenimahalle, Turkey (Türkiye)
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Adana, Yuregir, Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Istanbul, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
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Kecioren Ankara, , Turkey (Türkiye)
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Konya, , Turkey (Türkiye)
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Samsun, , Turkey (Türkiye)
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-503001-38-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
CLEE011O12001
Identifier Type: -
Identifier Source: org_study_id
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