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RECRUITING Phase 3 ClinicalTrials.gov

Phase IIIb Study of Ribociclib + ET in Early Breast Cancer

Sponsor: Novartis Pharmaceuticals • ClinicalTrials.gov ID: NCT05827081

Registry updated: 2026-10-19
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Description

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).

Interventions

  • Ribociclib (Drug)
    Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest
  • Letrozole (Drug)
    Letrozole 2.5 mg orally once daily continuously
  • Ansastrozole (Drug)
    Anastrozole 1 mg orally once daily continuously.
  • Goserelin (Drug)
    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 (Drug)
    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 (Drug)
    Exemestane 25 mg once daily continuously

Eligibility criteria

Key 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. Other inclusion/exclusion criteria may apply

Conditions

Early Breast Cancer

Locations

  • 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
  • Good Samaritan Regional Medical Center — Corvallis, Oregon, 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
  • Allegheny Health Network — Pittsburgh, Pennsylvania, United States
  • Rhode Island Hospital — Providence, Rhode Island, United States
  • Bon Secours St Francis Cancer Center — Greenville, South Carolina, United States
  • Lexington Medical Center — West Columbia, South Carolina, United States
  • Regional Medical Oncology NC — Wilson, South Carolina, 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
  • Kelsey Seybold Clinic — Houston, 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
  • Kadlec Clinic Hematology and Onco — Kennewick, Washington, United States
  • Providence Regional Cancer System — Lacey, Washington, United States
  • Valley Medical Center Research — Renton, Washington, United States
  • Northwest Medical Specialties — Tacoma, Washington, United States
  • Medical College of Wisconsin — Milwaukee, Wisconsin, United States
  • Novartis Investigative Site — Caba, Buenos Aires, Argentina
  • Novartis Investigative Site — La Plata, Buenos Aires, Argentina
  • Novartis Investigative Site — Córdoba, Argentina
  • Novartis Investigative Site — Gateshead, New South Wales, Australia
  • Novartis Investigative Site — Tiwi, Northern Territory, Australia
  • Novartis Investigative Site — Clayton, Victoria, Australia
  • Novartis Investigative Site — East Melbourne, Victoria, Australia
  • Novartis Investigative Site — Salvador, Estado de Bahia, Brazil
  • Novartis Investigative Site — Belo Horizonte, Minas Gerais, Brazil
  • Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
  • Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
  • Novartis Investigative Site — Porto Alegre, Rio Grande do Sul, Brazil
  • Novartis Investigative Site — São Paulo, São Paulo, Brazil
  • Novartis Investigative Site — São Paulo, São Paulo, Brazil
  • Novartis Investigative Site — Rio de Janeiro, Brazil
  • Novartis Investigative Site — Rio de Janeiro, Brazil
  • Novartis Investigative Site — São Paulo, Brazil
  • Novartis Investigative Site — Victoria, British Columbia, Canada
  • Novartis Investigative Site — Halifax, Nova Scotia, Canada
  • Novartis Investigative Site — Oakville, Ontario, Canada
  • Novartis Investigative Site — Ottawa, Ontario, Canada
  • Novartis Investigative Site — Toronto, Ontario, Canada
  • Novartis Investigative Site — Toronto, Ontario, Canada
  • Novartis Investigative Site — Montreal, Quebec, Canada
  • Novartis Investigative Site — Montreal, Quebec, Canada
  • Novartis Investigative Site — Montreal, Quebec, Canada
  • Novartis Investigative Site — Québec, Quebec, Canada
  • Novartis Investigative Site — Saskatoon, Saskatchewan, Canada
  • Novartis Investigative Site — Beijing, Beijing Municipality, China
  • Novartis Investigative Site — Guangzhou, Guangdong, China
  • Novartis Investigative Site — Harbin, Heilongjiang, China
  • Novartis Investigative Site — Zhengzhou, Henan, China
  • Novartis Investigative Site — Zhengzhou, Henan, China
  • Novartis Investigative Site — Nanjing, Jiangsu, China
  • Novartis Investigative Site — Nanchang, Jiangxi, China
  • Novartis Investigative Site — Changchun, Jilin, China
  • Novartis Investigative Site — Jinan, Shandong, China
  • Novartis Investigative Site — Jinan, Shandong, China
  • Novartis Investigative Site — Jining, Shandong, China
  • Novartis Investigative Site — Chengdu, Sichuan, China
  • Novartis Investigative Site — Chengdu, Sichuan, China
  • Novartis Investigative Site — Ürümqi, Xinjiang, China
  • Novartis Investigative Site — Hangzhou, Zhejiang, China
  • Novartis Investigative Site — Hangzhou, Zhejiang, China
  • Novartis Investigative Site — Wenzhou, Zhejiang, China
  • Novartis Investigative Site — Beijing, China
  • Novartis Investigative Site — Beijing, China
  • Novartis Investigative Site — Guangzhou, China
  • Novartis Investigative Site — Qingdao, China
  • Novartis Investigative Site — Shanghai, China
  • Novartis Investigative Site — Shijiazhuang, China
  • Novartis Investigative Site — Tianjin, China
  • Novartis Investigative Site — Freiburg im Breisgau, Baden-Wurttemberg, Germany
  • Novartis Investigative Site — Munich, Bavaria, Germany
  • Novartis Investigative Site — Regensburg, Bavaria, Germany
  • Novartis Investigative Site — Weiden in Der Oberpfalz, Bavaria, Germany
  • Novartis Investigative Site — Langen, Hesse, Germany
  • Novartis Investigative Site — Hildesheim, Lower Saxony, Germany
  • Novartis Investigative Site — Bergisch Gladbach, North Rhine-Westphalia, Germany
  • Novartis Investigative Site — Bielefeld, North Rhine-Westphalia, Germany
  • Novartis Investigative Site — Düsseldorf, North Rhine-Westphalia, Germany
  • Novartis Investigative Site — Essen, North Rhine-Westphalia, Germany
  • Novartis Investigative Site — Mönchengladbach, North Rhine-Westphalia, Germany
  • Novartis Investigative Site — Velbert, North Rhine-Westphalia, Germany
  • Novartis Investigative Site — Dresden, Saxony, Germany
  • Novartis Investigative Site — Lübeck, Schleswig-Holstein, Germany
  • Novartis Investigative Site — Augsburg, Germany
  • Novartis Investigative Site — Augsburg, Germany
  • Novartis Investigative Site — Berlin, Germany
  • Novartis Investigative Site — Berlin, Germany
  • Novartis Investigative Site — Bottrop, Germany
  • Novartis Investigative Site — Böblingen, Germany
  • Novartis Investigative Site — Dessau, Germany
  • Novartis Investigative Site — Erlangen, Germany
  • Novartis Investigative Site — Essen, Germany
  • Novartis Investigative Site — Hamburg, Germany
  • Novartis Investigative Site — Kiel, Germany
  • Novartis Investigative Site — Leipzig, Germany
  • Novartis Investigative Site — Mainz, Germany
  • Novartis Investigative Site — München, Germany
  • Novartis Investigative Site — Ravensburg, Germany
  • Novartis Investigative Site — Hong Kong, Hong Kong
  • Novartis Investigative Site — Kowloon, Hong Kong
  • Novartis Investigative Site — Tuenmen, Hong Kong
  • Novartis Investigative Site — Hyderabad, Andhra Pradesh, India
  • Novartis Investigative Site — Bangalore, Karnataka, India
  • Novartis Investigative Site — Mumbai, Maharashtra, India
  • Novartis Investigative Site — Pune, Maharasthra, India
  • Novartis Investigative Site — New Delhi, National Capital Territory of Delhi, India
  • Novartis Investigative Site — Bhubaneswar, Odisha, India
  • Novartis Investigative Site — Chennai, Tamil Nadu, India
  • Novartis Investigative Site — Kolkata, West Bengal, India
  • Novartis Investigative Site — Ahmedabad, India
  • Novartis Investigative Site — Beersheba, Israel
  • Novartis Investigative Site — Petah Tikva, Israel
  • Novartis Investigative Site — Ramat Gan, Israel
  • Novartis Investigative Site — Tel Aviv, Israel
  • Novartis Investigative Site — Alc Cuahutemoc, Mexico City, Mexico
  • Novartis Investigative Site — Tlalpan, Mexico City, Mexico
  • Novartis Investigative Site — Monterrey, Nuevo León, Mexico
  • Novartis Investigative Site — Coimbra, Portugal
  • Novartis Investigative Site — Lisbon, Portugal
  • Novartis Investigative Site — Lisbon, Portugal
  • Novartis Investigative Site — Porto, Portugal
  • Novartis Investigative Site — Porto, Portugal
  • Novartis Investigative Site — Porto, Portugal
  • Pan Oncology — Rio Piedras, Puerto Rico
  • Novartis Investigative Site — Bundang Gu, Gyeonggi-do, South Korea
  • Novartis Investigative Site — Gyeonggi-do, Korea, South Korea
  • Novartis Investigative Site — Seoul, Korea, South Korea
  • Novartis Investigative Site — Seoul, Yangcheon Gu, South Korea
  • Novartis Investigative Site — Incheon, South Korea
  • Novartis Investigative Site — Seongnam Gyeonggi, South Korea
  • Novartis Investigative Site — Seoul, South Korea
  • Novartis Investigative Site — Seoul, South Korea
  • Novartis Investigative Site — Seoul, South Korea
  • Novartis Investigative Site — Seoul, South Korea
  • Novartis Investigative Site — Seoul, South Korea
  • Novartis Investigative Site — Seoul, South Korea
  • Novartis Investigative Site — Hualien City, Taiwan
  • Novartis Investigative Site — Kaohsiung City, Taiwan
  • Novartis Investigative Site — Tainan, Taiwan
  • Novartis Investigative Site — Taipei, Taiwan
  • Novartis Investigative Site — Taipei, Taiwan
  • Novartis Investigative Site — Sakarya, Adapazari, Turkey (Türkiye)
  • Novartis Investigative Site — Ankara, Bilkent Cankaya, Turkey (Türkiye)
  • Novartis Investigative Site — Istanbul, Fatih, Turkey (Türkiye)
  • Novartis Investigative Site — Istanbul, Kadikoy, Turkey (Türkiye)
  • Novartis Investigative Site — Izmir, Karsiyaka, Turkey (Türkiye)
  • Novartis Investigative Site — Denizli, Kinikli, Turkey (Türkiye)
  • Novartis Investigative Site — Antalya, Konyaalti, Turkey (Türkiye)
  • Novartis Investigative Site — Istanbul, Sariyer, Turkey (Türkiye)
  • Novartis Investigative Site — Ankara, Sihhiye Altindag, Turkey (Türkiye)
  • Novartis Investigative Site — Diyarbakır, Sur, Turkey (Türkiye)
  • Novartis Investigative Site — Istanbul, Uskudar, Turkey (Türkiye)
  • Novartis Investigative Site — Ankara, Yenimahalle, Turkey (Türkiye)
  • Novartis Investigative Site — Ankara, Yenimahalle, Turkey (Türkiye)
  • Novartis Investigative Site — Adana, Yuregir, Turkey (Türkiye)
  • Novartis Investigative Site — Ankara, Turkey (Türkiye)
  • Novartis Investigative Site — Istanbul, Turkey (Türkiye)
  • Novartis Investigative Site — Izmir, Turkey (Türkiye)
  • Novartis Investigative Site — Kecioren Ankara, Turkey (Türkiye)
  • Novartis Investigative Site — Konya, Turkey (Türkiye)
  • Novartis Investigative Site — Samsun, Turkey (Türkiye)
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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