Phase IIIb Study of Ribociclib + ET in Early Breast Cancer (Adjuvant WIDER)

June 8, 2026 updated by: Novartis Pharmaceuticals

A Phase IIIb Study to Characterize the Efficacy and Safety of Adjuvant Ribociclib Plus Endocrine Therapy in a Close-to-clinical Practice Patient Population With HR+ HER2- Early Breast Cancer (Adjuvant WIDER)

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

1400

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Córdoba, Argentina, X5004BAL
        • Recruiting
        • Novartis Investigative Site
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • Novartis Investigative Site
      • La Plata, Buenos Aires, Argentina, B1902CMV
        • Recruiting
        • Novartis Investigative Site
  • Australia
    • New South Wales
      • Gateshead, New South Wales, Australia, 2290
        • Recruiting
        • Novartis Investigative Site
    • Northern Territory
      • Tiwi, Northern Territory, Australia, 810
        • Recruiting
        • Novartis Investigative Site
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Novartis Investigative Site
      • East Melbourne, Victoria, Australia, 3002
        • Recruiting
        • Novartis Investigative Site
  • Brazil
      • São Paulo, Brazil, 04501 000
        • Recruiting
        • Novartis Investigative Site
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 40170-110
        • Recruiting
        • Novartis Investigative Site
      • Salvador, Estado de Bahia, Brazil, 41825-010
        • Recruiting
        • Novartis Investigative Site
    • Rio Grande do Sul
      • Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
        • Recruiting
        • Novartis Investigative Site
      • Porto Alegre, Rio Grande do Sul, Brazil, 90470-340
        • Recruiting
        • Novartis Investigative Site
    • São Paulo
      • São Paulo, São Paulo, Brazil, 05652-000
        • Recruiting
        • Novartis Investigative Site
  • Canada
    • British Columbia
      • Victoria, British Columbia, Canada, V8R 6V5
        • Recruiting
        • Novartis Investigative Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y9
        • Recruiting
        • Novartis Investigative Site
    • Ontario
      • Oakville, Ontario, Canada, L6M1M1
        • Recruiting
        • Novartis Investigative Site
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • Novartis Investigative Site
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Novartis Investigative Site
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • Novartis Investigative Site
      • Montreal, Quebec, Canada, H2X 0A9
        • Recruiting
        • Novartis Investigative Site
      • Québec, Quebec, Canada, G1S 4L8
        • Recruiting
        • Novartis Investigative Site
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 4H4
        • Recruiting
        • Novartis Investigative Site
  • China
      • Beijing, China, 100730
        • Recruiting
        • Novartis Investigative Site
      • Beijing, China, 100039
        • Recruiting
        • Novartis Investigative Site
      • Guangzhou, China, 510060
        • Recruiting
        • Novartis Investigative Site
      • Qingdao, China, 266000
        • Recruiting
        • Novartis Investigative Site
      • Shanghai, China, 200032
        • Recruiting
        • Novartis Investigative Site
      • Shijiazhuang, China, 050035
        • Recruiting
        • Novartis Investigative Site
      • Tianjin, China, 300480
        • Recruiting
        • Novartis Investigative Site
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Recruiting
        • Novartis Investigative Site
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Novartis Investigative Site
    • Heilongjiang
      • Harbin, Heilongjiang, China, 150081
        • Recruiting
        • Novartis Investigative Site
    • Henan
      • Zhengzhou, Henan, China, 450008
        • Recruiting
        • Novartis Investigative Site
      • Zhengzhou, Henan, China, 450003
        • Recruiting
        • Novartis Investigative Site
    • Jiangsu
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Novartis Investigative Site
    • Jiangxi
      • Nanchang, Jiangxi, China, 330009
        • Recruiting
        • Novartis Investigative Site
    • Jilin
      • Changchun, Jilin, China, 130021
        • Recruiting
        • Novartis Investigative Site
    • Shandong
      • Jinan, Shandong, China, 250117
        • Recruiting
        • Novartis Investigative Site
      • Jinan, Shandong, China, 250021
        • Active, not recruiting
        • Novartis Investigative Site
      • Jining, Shandong, China, 272000
        • Recruiting
        • Novartis Investigative Site
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • Recruiting
        • Novartis Investigative Site
      • Chengdu, Sichuan, China, 610072
        • Recruiting
        • Novartis Investigative Site
    • Xinjiang
      • Ürümqi, Xinjiang, China, 830000
        • Recruiting
        • Novartis Investigative Site
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310006
        • Recruiting
        • Novartis Investigative Site
      • Hangzhou, Zhejiang, China, 310022
        • Recruiting
        • Novartis Investigative Site
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • Novartis Investigative Site
  • Germany
      • Augsburg, Germany, 86179
        • Recruiting
        • Novartis Investigative Site
      • Augsburg, Germany, 86150
        • Recruiting
        • Novartis Investigative Site
      • Berlin, Germany, 13125
        • Recruiting
        • Novartis Investigative Site
      • Berlin, Germany, 10967
        • Recruiting
        • Novartis Investigative Site
      • Bottrop, Germany, 46236
        • Recruiting
        • Novartis Investigative Site
      • Böblingen, Germany, 71032
        • Withdrawn
        • Novartis Investigative Site
      • Dessau, Germany, 06847
        • Recruiting
        • Novartis Investigative Site
      • Erlangen, Germany, 91054
        • Recruiting
        • Novartis Investigative Site
      • Essen, Germany, 45147
        • Recruiting
        • Novartis Investigative Site
      • Hamburg, Germany, 20246
        • Withdrawn
        • Novartis Investigative Site
      • Kiel, Germany, 24105
        • Recruiting
        • Novartis Investigative Site
      • Leipzig, Germany, 04277
        • Recruiting
        • Novartis Investigative Site
      • Mainz, Germany, 55131
        • Withdrawn
        • Novartis Investigative Site
      • München, Germany, 80637
        • Recruiting
        • Novartis Investigative Site
      • Ravensburg, Germany, 88214
        • Recruiting
        • Novartis Investigative Site
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Recruiting
        • Novartis Investigative Site
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Recruiting
        • Novartis Investigative Site
      • Regensburg, Bavaria, Germany, 93053
        • Recruiting
        • Novartis Investigative Site
      • Weiden in Der Oberpfalz, Bavaria, Germany, 92637
        • Recruiting
        • Novartis Investigative Site
    • Hesse
      • Langen, Hesse, Germany, 63225
        • Recruiting
        • Novartis Investigative Site
    • Lower Saxony
      • Hildesheim, Lower Saxony, Germany, 31134
        • Withdrawn
        • Novartis Investigative Site
    • North Rhine-Westphalia
      • Bergisch Gladbach, North Rhine-Westphalia, Germany, 51465
        • Recruiting
        • Novartis Investigative Site
      • Bielefeld, North Rhine-Westphalia, Germany, 33604
        • Withdrawn
        • Novartis Investigative Site
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Withdrawn
        • Novartis Investigative Site
      • Essen, North Rhine-Westphalia, Germany, 45136
        • Recruiting
        • Novartis Investigative Site
      • Mönchengladbach, North Rhine-Westphalia, Germany, 41061
        • Recruiting
        • Novartis Investigative Site
      • Velbert, North Rhine-Westphalia, Germany, 42551
        • Recruiting
        • Novartis Investigative Site
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • Novartis Investigative Site
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23563
        • Withdrawn
        • Novartis Investigative Site
  • Hong Kong
      • Hong Kong, Hong Kong, 999077
        • Recruiting
        • Novartis Investigative Site
      • Kowloon, Hong Kong, 999077
        • Recruiting
        • Novartis Investigative Site
      • Tuenmen, Hong Kong, 999077
        • Recruiting
        • Novartis Investigative Site
  • India
      • Ahmedabad, India, 380054
        • Active, not recruiting
        • Novartis Investigative Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500034
        • Active, not recruiting
        • Novartis Investigative Site
    • Karnataka
      • Bangalore, Karnataka, India, 560017
        • Active, not recruiting
        • Novartis Investigative Site
    • Maharashtra
      • Mumbai, Maharashtra, India, 400 012
        • Active, not recruiting
        • Novartis Investigative Site
    • Maharasthra
      • Pune, Maharasthra, India, 411028
        • Active, not recruiting
        • Novartis Investigative Site
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • Active, not recruiting
        • Novartis Investigative Site
    • Odisha
      • Bhubaneswar, Odisha, India, 751007
        • Active, not recruiting
        • Novartis Investigative Site
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600 035
        • Active, not recruiting
        • Novartis Investigative Site
    • West Bengal
      • Kolkata, West Bengal, India, 700054
        • Active, not recruiting
        • Novartis Investigative Site
  • Israel
      • Beersheba, Israel, 8457108
        • Recruiting
        • Novartis Investigative Site
      • Petah Tikva, Israel, 4941492
        • Recruiting
        • Novartis Investigative Site
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Novartis Investigative Site
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Novartis Investigative Site
  • Mexico
    • Mexico City
      • Alc Cuahutemoc, Mexico City, Mexico, 06720
        • Recruiting
        • Novartis Investigative Site
      • Tlalpan, Mexico City, Mexico, 14080
        • Recruiting
        • Novartis Investigative Site
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Recruiting
        • Novartis Investigative Site
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Recruiting
        • Novartis Investigative Site
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • Novartis Investigative Site
      • Lisbon, Portugal, 1400-038
        • Recruiting
        • Novartis Investigative Site
      • Porto, Portugal, 4200-072
        • Recruiting
        • Novartis Investigative Site
      • Porto, Portugal, 4100-180
        • Recruiting
        • Novartis Investigative Site
      • Porto, Portugal, 4200 319
        • Recruiting
        • Novartis Investigative Site
  • Puerto Rico
      • Rio Piedras, Puerto Rico, 00935
  • South Korea
      • Seongnam Gyeonggi, South Korea, 463-712
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 03080
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 05505
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 06591
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 03722
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 06351
        • Recruiting
        • Novartis Investigative Site
      • Seoul, South Korea, 06273
        • Recruiting
        • Novartis Investigative Site
    • Gyeonggi-do
      • Bundang Gu, Gyeonggi-do, South Korea, 13620
        • Recruiting
        • Novartis Investigative Site
    • Korea
      • Gyeonggi-do, Korea, South Korea, 10408
        • Recruiting
        • Novartis Investigative Site
      • Incheon, Korea, South Korea, 405 760
        • Recruiting
        • Novartis Investigative Site
      • Seoul, Korea, South Korea, 02841
        • Recruiting
        • Novartis Investigative Site
    • Yangcheon Gu
      • Seoul, Yangcheon Gu, South Korea, 07985
        • Recruiting
        • Novartis Investigative Site
  • Taiwan
      • Hualien City, Taiwan, 970
        • Recruiting
        • Novartis Investigative Site
      • Kaohsiung City, Taiwan, 80756
        • Recruiting
        • Novartis Investigative Site
      • Tainan, Taiwan, 71004
        • Recruiting
        • Novartis Investigative Site
      • Taipei, Taiwan, 10002
        • Recruiting
        • Novartis Investigative Site
      • Taipei, Taiwan, 114
        • Recruiting
        • Novartis Investigative Site
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06520
        • Recruiting
        • Novartis Investigative Site
      • Istanbul, Turkey (Türkiye), 34147
        • Recruiting
        • Novartis Investigative Site
      • Izmir, Turkey (Türkiye), 35100
        • Recruiting
        • Novartis Investigative Site
      • Kecioren Ankara, Turkey (Türkiye), 06010
        • Recruiting
        • Novartis Investigative Site
      • Konya, Turkey (Türkiye), 42080
        • Recruiting
        • Novartis Investigative Site
      • Samsun, Turkey (Türkiye), 55200
        • Recruiting
        • Novartis Investigative Site
    • Adapazari
      • Sakarya, Adapazari, Turkey (Türkiye), 54290
        • Recruiting
        • Novartis Investigative Site
    • Bilkent-Cankaya
      • Ankara, Bilkent-Cankaya, Turkey (Türkiye), 06800
        • Recruiting
        • Novartis Investigative Site
    • Fatih
      • Istanbul, Fatih, Turkey (Türkiye), 34098
        • Recruiting
        • Novartis Investigative Site
    • Kadikoy
      • Istanbul, Kadikoy, Turkey (Türkiye), 34722
        • Recruiting
        • Novartis Investigative Site
    • Karsiyaka
      • Izmir, Karsiyaka, Turkey (Türkiye), 35575
        • Recruiting
        • Novartis Investigative Site
    • Kinikli
      • Denizli, Kinikli, Turkey (Türkiye), 20070
        • Recruiting
        • Novartis Investigative Site
    • Konyaalti
      • Antalya, Konyaalti, Turkey (Türkiye), 07070
        • Recruiting
        • Novartis Investigative Site
    • Sariyer
      • Istanbul, Sariyer, Turkey (Türkiye), 34457
        • Recruiting
        • Novartis Investigative Site
    • Sihhiye-Altindag
      • Ankara, Sihhiye-Altindag, Turkey (Türkiye), 06230
        • Recruiting
        • Novartis Investigative Site
    • Sur
      • Diyarbakır, Sur, Turkey (Türkiye), 21280
        • Recruiting
        • Novartis Investigative Site
    • Uskudar
      • Istanbul, Uskudar, Turkey (Türkiye), 34662
        • Recruiting
        • Novartis Investigative Site
    • Yenimahalle
      • Ankara, Yenimahalle, Turkey (Türkiye), 06200
        • Recruiting
        • Novartis Investigative Site
      • Ankara, Yenimahalle, Turkey (Türkiye), 06500
        • Recruiting
        • Novartis Investigative Site
    • Yuregir
      • Adana, Yuregir, Turkey (Türkiye), 01230
        • Recruiting
        • Novartis Investigative Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Alaska Oncology and Hematology LLC
        • Principal Investigator:
          • Steven Liu
        • Contact:
    • Arizona
      • Goodyear, Arizona, United States, 85338
        • Recruiting
        • Western Reg MC-COH Phoenix
        • Principal Investigator:
          • Cynthia Lynch
        • Contact:
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Recruiting
        • CARTI Cancer Center
        • Contact:
        • Principal Investigator:
          • Issam Sam Makhoul
    • California
      • Beverly Hills, California, United States, 90211
        • Recruiting
        • Beverly Hills Cancer Center
        • Principal Investigator:
          • Linnea Chap
        • Contact:
      • Cerritos, California, United States, 90703
        • Recruiting
        • Onco Inst of Hope and Innovation
        • Principal Investigator:
          • Pamela Miel
        • Contact:
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope National Medical
        • Principal Investigator:
          • Thanh Nga Doan
        • Contact:
          • Felicia Lewis
          • Phone Number: +1 6263598111#65994
          • Email: flewis@coh.org
      • Fullerton, California, United States, 92835
        • Recruiting
        • Providence Medical Foundation
        • Principal Investigator:
          • Giribala R Patel
        • Contact:
      • Mountain View, California, United States, 94040
        • Recruiting
        • Palo Alto Medical Foundation
        • Principal Investigator:
          • Natalia Colocci
        • Contact:
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Medical Center
        • Principal Investigator:
          • Ritesh Parajuli
        • Contact:
      • Sacramento, California, United States, 95817
      • Sacramento, California, United States, 95816-5199
        • Recruiting
        • Sutter Inst Medical Research
        • Principal Investigator:
          • Nitin Rohatgi
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Rocky Mountain Cancer Centers
        • Principal Investigator:
          • Mabel Mardones
        • Contact:
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Washington Hospital Center
        • Principal Investigator:
          • Ami Chitalia
        • Contact:
      • Washington D.C., District of Columbia, United States, 20007-2197
        • Recruiting
        • Georgetown University Lombardi Cancer Center
        • Principal Investigator:
          • Katia Khoury
        • Contact:
    • Florida
      • Altamonte Springs, Florida, United States, 32701
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Holy Cross Health
        • Principal Investigator:
          • Karim Arnaout
        • Contact:
      • Hialeah, Florida, United States, 33013
      • Hollywood, Florida, United States, 33021
        • Recruiting
        • Memorial Cancer Institute
        • Principal Investigator:
          • Adriana Milillo Naraine
        • Contact:
      • Jupiter, Florida, United States, 33458
        • Recruiting
        • Jupiter Medical Center
        • Principal Investigator:
          • Danielle Krol
        • Contact:
      • Ocala, Florida, United States, 34474
        • Recruiting
        • Ocala Research Institute, Inc
        • Principal Investigator:
          • Anju Vasudevan
        • Contact:
    • Georgia
      • Athens, Georgia, United States, 30607
        • Recruiting
        • University Cancer and Blood Center LLC
        • Principal Investigator:
          • Amanda Hathaway
        • Contact:
      • Savannah, Georgia, United States, 31405
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
    • Illinois
      • Chicago, Illinois, United States, 60415
      • Hinsdale, Illinois, United States, 60521
        • Recruiting
        • Hope And Healing Care
        • Principal Investigator:
          • Srilata Gundala
        • Contact:
      • Zion, Illinois, United States, 60099
        • Recruiting
        • Midwestern Reg MC COH Chicago
        • Principal Investigator:
          • Ajaz Khan
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • Investigative Clinical R of Indiana
        • Principal Investigator:
          • Ruemu Birhiray
        • Contact:
    • Iowa
      • Waukee, Iowa, United States, 50263
        • Recruiting
        • University of Iowa Health Care
        • Principal Investigator:
          • Seema Harichand-Herdt
        • Contact:
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Cancer Center
        • Principal Investigator:
          • Priyanka Sharma
        • Contact:
      • Wichita, Kansas, United States, 67214-3728
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Recruiting
        • Willis-Knighton Cancer Center
        • Principal Investigator:
          • Prakash Peddi
        • Contact:
    • Maryland
      • Baltimore, Maryland, United States, 21202
        • Recruiting
        • Mercy Medical Center
        • Principal Investigator:
          • David Andrew Riseberg
        • Contact:
      • Silver Spring, Maryland, United States, 20904
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana Farber Cancer Institute
        • Principal Investigator:
          • Erica Mayer
        • Contact:
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center
        • Contact:
        • Principal Investigator:
          • Jose J Acevedo
      • Milford, Massachusetts, United States, 01757
        • Recruiting
        • Dana Farber Brigham Women Cancer
        • Principal Investigator:
          • Natalie Sinclair
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Recruiting
        • Minnesota Oncology Hematology P A
        • Contact:
        • Principal Investigator:
          • Eric Lander
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Allina Hlth Cancer Inst Minneapolis
        • Principal Investigator:
          • Daniel Carlson
        • Contact:
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Recruiting
        • Jackson Oncology Associates
        • Principal Investigator:
          • Justin T Baker
        • Contact:
    • Missouri
      • Kansas City, Missouri, United States, 64132
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • WA Uni School Of Med
        • Principal Investigator:
          • Katherine Clifton
        • Contact:
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • Intermountain Healthcare
        • Principal Investigator:
          • Patrick Cobb
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68154
        • Recruiting
        • Nebraska Cancer Specialists
        • Principal Investigator:
          • Margaret Barbara Block
        • Contact:
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center
        • Principal Investigator:
          • Lee Schwartzberg
        • Contact:
      • Reno, Nevada, United States, 89511
        • Recruiting
        • Cancer Care Specialists
        • Contact:
        • Principal Investigator:
          • Sowjanya Reganti
    • New Jersey
      • Florham Park, New Jersey, United States, 07932
        • Recruiting
        • Summit Health
        • Principal Investigator:
          • Steven Papish
        • Contact:
      • Ridgewood, New Jersey, United States, 07450
        • Recruiting
        • The Valley Hospital
        • Principal Investigator:
          • Amanda Podolski
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87110
        • Recruiting
        • Presbyterian Medical Group
        • Contact:
        • Principal Investigator:
          • Yashvin Onkarappa Mangala
    • New York
      • Jamaica, New York, United States, 11432
        • Recruiting
        • Queens Cancer Center of Queens Hospital
        • Contact:
        • Principal Investigator:
          • Ellen Hagopian
      • Lake Success, New York, United States, 11042
        • Recruiting
        • Optum Health
        • Contact:
        • Principal Investigator:
          • Jonathan Goldberg
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai School of Medicine
        • Principal Investigator:
          • Melanie Kier
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Network
        • Contact:
        • Principal Investigator:
          • Madhu Chaudhry
      • Greensboro, North Carolina, United States, 27403
        • Recruiting
        • Cone Health Cancer Center
        • Principal Investigator:
          • Vinay Gudena
        • Contact:
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Recruiting
        • Sanford Research USD Fargo
        • Contact:
        • Principal Investigator:
          • Anu Goel Gaba
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Recruiting
        • Good Samaritan Regional Medical Center
        • Principal Investigator:
          • John Strother
        • Contact:
      • Eugene, Oregon, United States, 97401-8122
        • Recruiting
        • Oncology Associates of Oregon PC
        • Principal Investigator:
          • Miho Dougherty
        • Contact:
      • Portland, Oregon, United States, 97210
        • Recruiting
        • Northwest Cancer Specialists
        • Principal Investigator:
          • Jay Andersen
        • Contact:
      • Salem, Oregon, United States, 97301
        • Recruiting
        • Oregon Oncology Specialists Salem
        • Principal Investigator:
          • Janelle Meyer
        • Contact:
    • Pennsylvania
      • Drexel Hill, Pennsylvania, United States, 19026
      • Harrisburg, Pennsylvania, United States, 17109
        • Recruiting
        • Univ of Pittsburg Med Ctr Pinnacle
        • Principal Investigator:
          • Marija Balic
        • Contact:
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Principal Investigator:
          • Stephanie Graff
        • Contact:
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Bon Secours St Francis Cancer Center
        • Principal Investigator:
          • Stephen Howard Dyar
        • Contact:
      • West Columbia, South Carolina, United States, 29169
        • Recruiting
        • Lexington Medical Center
        • Principal Investigator:
          • Steven Madden
        • Contact:
      • Wilson, South Carolina, United States, 27893
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Recruiting
        • Sanford USD Medical Center
        • Contact:
        • Principal Investigator:
          • Allison Watson
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute
        • Principal Investigator:
          • Denise A Yardley
        • Contact:
    • Texas
      • El Paso, Texas, United States, 79902
      • Houston, Texas, United States, 77025
      • Houston, Texas, United States, 77030-4099
        • Recruiting
        • University of Texas
        • Principal Investigator:
          • Jason Mouabbi
        • Contact:
      • Plano, Texas, United States, 75075
        • Recruiting
        • Texas Oncology P A Plano East
        • Principal Investigator:
          • Carlos Taboada
        • Contact:
      • Tyler, Texas, United States, 75702
    • Virginia
      • Midlothian, Virginia, United States, 23114
        • Recruiting
        • Bon Secours Virginia Health System
        • Principal Investigator:
          • William Irvin
        • Contact:
      • Norfolk, Virginia, United States, 23502
        • Recruiting
        • Virginia Oncology Associates
        • Principal Investigator:
          • Michael A Danso
        • Contact:
    • Washington
      • Kennewick, Washington, United States, 99336
        • Recruiting
        • Kadlec Clinic Hematology and Onco
        • Principal Investigator:
          • Ying Zhuo
        • Contact:
      • Lacey, Washington, United States, 98503
        • Recruiting
        • Providence Regional Cancer System
        • Principal Investigator:
          • Mijung Lee
        • Contact:
      • Renton, Washington, United States, 98055
        • Recruiting
        • Valley Medical Center Research
        • Principal Investigator:
          • Navanshu Arora
        • Contact:
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • Northwest Medical Specialties
        • Principal Investigator:
          • Sibel Blau
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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)
Drug: Letrozole
Letrozole 2.5 mg orally once daily continuously
Drug: Ansastrozole
Anastrozole 1 mg orally once daily continuously.
Drug: Ribociclib
Ribociclib 400 mg orally once daily on days 1-21 of a 28 day cycle followed by 7 days rest
Other Names:
  • LEE011
Drug: 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
Drug: Exemestane
Exemestane 25 mg once daily continuously
Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive Breast Cancer Free Survival (iBCFS) rate at 3 years
Time Frame: At 3 years

iBCFS is defined as the time from the date of first dose to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), or contralateral invasive BC. iBCFS will be assessed using STEEP criteria version 2.0 (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials), as assessed by Investigator.

The iBCFS rate at 3 years will be assessed.
At 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Invasive Disease-Free Survival (iDFS)
Time Frame: Up to approximately 6 years
iDFS is defined as the time from the date of first dose of study treatment to the date of the first event of invasive ipsilateral breast tumor recurrence, local/regional invasive recurrence, distant recurrence, death (any cause), contralateral invasive BC, or second primary non-breast invasive cancer (excluding basal and squamous cell carcinomas of the skin). iDFS will be assessed using STEEP 2.0 as assessed by the investigator.
Up to approximately 6 years
Distant Relapse-Free Survival (DRFS)
Time Frame: Up to approximately 6 years
Distant Relapse Free Survival (DRFS) is defined as the time from the date of first dose of study treatment to the date of the first event of recurrence at a distant site or death (any cause). DRFS will be assessed using STEEP 2.0 as assessed by the investigator.
Up to approximately 6 years
Recurrence-Free Interval (RFI)
Time Frame: Up to approximately 6 years
RFI is defined as the time from date of first dose to date of first event of invasive recurrence in the ipsilateral breast or locoregionally, at a distant site, or death from breast cancer. RFI will be assessed using STEEP 2.0 as per investigator assessment.
Up to approximately 6 years
Relative dose intensity (RDI) of ribociclib
Time Frame: Up to 3 years
RDI is defined as the ratio of the dose intensity delivered to the planned dose intensity.
Up to 3 years
Overall Survival (OS)
Time Frame: Up to approximately 6 years
OS is defined as time from the start of study treatment to date of death due to any cause.
Up to approximately 6 years
Time To Discontinuation (TTD) of ribociclib
Time Frame: Up to 3 years
TTD is defined as the time from starting ribociclib to the time to treatment discontinuation due to any cause.
Up to 3 years
Changes from baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) score
Time Frame: Up to approximately 6 years
The FACT-B is a questionnaire that consists of 37 items with items from FACT-General (FACT-G) questionnaire (27 items) and from the Breast Cancer Subscale (BCS, 10 items). FACT-B consists of five subscales that address different aspects of the participant's quality of life: physical well-being (PWB), social/family well-being (SWB), emotional well-being (EWB), functional well-being (FWB), and BCS.
Up to approximately 6 years
Changes from baseline in Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) score
Time Frame: Up to approximately 6 years
The FACT-ES is a questionnaire that consists of 19 items which assesses endocrine complaints and adverse events.
Up to approximately 6 years
Changes from baseline in Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) score
Time Frame: Up to approximately 6 years
The FACIT-F is a 13-item questionnaire designed to assess self-reported fatigue and its impact on daily activities and functions.
Up to approximately 6 years
Changes from baseline in European Quality of Life-5 Dimensions (EQ-5D-5L) score
Time Frame: Up to approximately 6 years
EQ-5D-5L is a standardized participant completed questionnaire that measures health-related quality of life and translates that score into an index value or utility score. EQ-5D-5L consists of two components: a health state profile and an optional visual analogue scale (VAS). EQ-5D-5L health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.
Up to approximately 6 years
Changes from baseline in Work Productivity and Activity Impairment Questionnaire (WPAI-GH) score
Time Frame: Up to approximately 6 years
WPAI-GH measures the impact of health problems on the participant's productivity, in paid or unpaid activities, in the last 7 days. It is 6-item scale measuring absenteeism, presenteeism, and impairments in unpaid activity.
Up to approximately 6 years
Incidence and severity of adverse events (AEs) using CTCAE v4.03
Time Frame: Up to approximately 6 years
To evaluate Safety of ribociclib + ET
Up to approximately 6 years
Distant Disease-Free Survival (DDFS)
Time Frame: Up to approximately 6 years

Distant Disease-Free Survival (DDFS) is defined as the time from the date of first dose of study treatment to the date of the first event of recurrence at a distant site, death (any cause), or second primary non-breast invasive cancer (excluding in situ/non-invasive cancers and basal and squamous cell carcinomas of the skin).

DDFS will be assessed using STEEP 2.0 as assessed by the investigator.
Up to approximately 6 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2024

Primary Completion (Estimated)

September 7, 2029

Study Completion (Estimated)

September 20, 2030

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

June 9, 2026

Last Update Submitted That Met QC Criteria

June 8, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLEE011O12001
  • 2022-503001-38-00 (Registry Identifier: EU CT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Early Breast Cancer

Clinical Trials on Letrozole

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe