Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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).
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Osoba dorosła, kobieta lub mężczyzna, w wieku 18 lat lub więcej
- •Potwierdzona histologicznie lub cytologicznie diagnoza raka piersi wrażliwego na estrogen i/lub progesteron
- •Rak piersi typu HER2-ujemny potwierdzone badaniami genetycznymi lub immunologicznymi
- •Możliwość wcześniejszego leczenia hormonalnego, ale rozpoczęte nie wcześniej niż 36 miesięcy przed włączeniem do badania
- •Całkowite chirurgiczne usunięcie guza bez остатков nowotworu w marginesach
- •Zaawansowana faza choroby III lub IIB (lub wybrany podzbiór II)
- •Ogólny stan zdrowia oceniony na 0-2 w skali ECOG
- •Prawidłowe funkcjonowanie szpiku kostnego i narządów oraz prawidłowe wyniki EKG
✗ Disqualifies
- •Przerzuty nowotworu poza węzły chłonne (stadium IV) lub dowód wznowy po operacji
- •Jednoczesne stosowanie innych leków przeciwnowotworowych poza leczeniem hormonalnym
- •Poważne, niekontrolowane schorzenia medyczne zagrażające bezpieczeństwu uczestnika
- •Niekontrolowana choroba serca lub zaburzenia rytmu serca
- •Ciąża, karmienie piersią lub planowanie ciąży podczas badania
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 100 Years
- Last updated (source)
- July 2, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (223)
Central Alabama Research
Birmingham, United States
Alaska Oncology and Hematology LLC
Anchorage, United States
Western Reg MC-COH Phoenix
Goodyear, United States
CARTI Cancer Center
Little Rock, United States
Beverly Hills Cancer Center
Beverly Hills, United States
Onco Inst of Hope and Innovation
Cerritos, United States
City of Hope National Medical
Duarte, United States
Providence Medical Foundation
Fullerton, United States
Los Angeles Cancer Network Good Samaritan
Los Angeles, United States
Palo Alto Medical Foundation
Mountain View, United States
UC Irvine Medical Center
Orange, United States
Sutter Inst Medical Research
Sacramento, United States
School Of Medicine
Sacramento, United States
Rocky Mountain Cancer Centers
Denver, United States
Georgetown University Lombardi Cancer Center
Washington D.C., United States
Washington Hospital Center
Washington D.C., United States
AdventHealth Altamonte Springs
Altamonte Springs, United States
Holy Cross Health
Fort Lauderdale, United States
Hialeah Hospital
Hialeah, United States
Memorial Cancer Institute
Hollywood, United States
Jupiter Medical Center
Jupiter, United States
Ocala Research Institute, Inc
Ocala, United States
University Cancer and Blood Center LLC
Athens, United States
Summit Cancer Care PC
Savannah, United States
Hawaii Cancer Care
Honolulu, United States
Affiliated Oncologists IL
Chicago, United States
Hope And Healing Care
Hinsdale, United States
Midwestern Reg MC COH Chicago
Zion, United States
Investigative Clinical R of Indiana
Indianapolis, United States
University of Iowa Health Care
Waukee, United States
University of Kansas Cancer Center
Westwood, United States
Cancer Center of Kansas
Wichita, United States
Willis-Knighton Cancer Center
Shreveport, United States
Mercy Medical Center
Baltimore, United States
Maryland Oncology Hematology P A
Silver Spring, United States
Boston Medical Center
Boston, United States
Dana Farber Cancer Institute
Boston, United States
Dana Farber Brigham Women Cancer
Milford, United States
Minnesota Oncology Hematology P A
Minneapolis, United States
Allina Hlth Cancer Inst Minneapolis
Minneapolis, United States
Jackson Oncology Associates
Jackson, United States
HCA Midwest Division
Kansas City, United States
WA Uni School Of Med
St Louis, United States
Intermountain Healthcare
Billings, United States
Nebraska Cancer Specialists
Omaha, United States
Renown Regional Medical Center
Reno, United States
Cancer Care Specialists
Reno, United States
MD Anderson Cancer Center At Cooper
Camden, United States
Summit Health
Florham Park, United States
The Valley Hospital
Ridgewood, United States
Presbyterian Medical Group
Albuquerque, United States
Queens Cancer Center of Queens Hospital
Jamaica, United States
Optum Health
Lake Success, United States
Mount Sinai School of Medicine
New York, United States
Duke Cancer Network
Durham, United States
Cone Health Cancer Center
Greensboro, United States
Sanford Research USD Fargo
Fargo, United States
Good Samaritan Regional Medical Center
Corvallis, United States
Oncology Associates of Oregon PC
Eugene, United States
Northwest Cancer Specialists
Portland, United States
Oregon Oncology Specialists Salem
Salem, United States
Consultants In Med Onco And Hema
Drexel Hill, United States
Univ of Pittsburg Med Ctr Pinnacle
Harrisburg, United States
Allegheny Health Network
Pittsburgh, United States
Rhode Island Hospital
Providence, United States
Bon Secours St Francis Cancer Center
Greenville, United States
Lexington Medical Center
West Columbia, United States
Regional Medical Oncology NC
Wilson, United States
Sanford USD Medical Center
Sioux Falls, United States
Sarah Cannon Research Institute
Nashville, United States
El Paso Texas Oncology
El Paso, United States
Kelsey Seybold Clinic
Houston, United States
University of Texas
Houston, United States
Texas Oncology P A Plano East
Plano, United States
Texas Oncology PA Tyler
Tyler, United States
Bon Secours Virginia Health System
Midlothian, United States
Virginia Oncology Associates
Norfolk, United States
Kadlec Clinic Hematology and Onco
Kennewick, United States
Providence Regional Cancer System
Lacey, United States
Valley Medical Center Research
Renton, United States
Northwest Medical Specialties
Tacoma, United States
Medical College of Wisconsin
Milwaukee, United States
Novartis Investigative Site
Caba, Argentina
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La Plata, Argentina
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Córdoba, Argentina
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Gateshead, Australia
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Tiwi, Australia
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Clayton, Australia
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East Melbourne, Australia
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Salvador, Brazil
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Salvador, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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Porto Alegre, Brazil
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São Paulo, Brazil
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Rio de Janeiro, Brazil
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São Paulo, Brazil
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Victoria, Canada
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Halifax, Canada
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Oakville, Canada
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Ottawa, Canada
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Toronto, Canada
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Montreal, Canada
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Montreal, Canada
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Montreal, Canada
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Québec, Canada
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Saskatoon, Canada
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Beijing, China
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Guangzhou, China
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Harbin, China
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Zhengzhou, China
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Zhengzhou, China
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Nanjing, China
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Nanchang, China
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Changchun, China
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Jinan, China
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Jinan, China
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Jining, China
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Chengdu, China
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Chengdu, China
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Ürümqi, China
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Hangzhou, China
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Hangzhou, China
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Wenzhou, 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, Germany
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Munich, Germany
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Regensburg, Germany
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Weiden in Der Oberpfalz, Germany
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Langen, Germany
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Hildesheim, Germany
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Bergisch Gladbach, Germany
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Bielefeld, Germany
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Düsseldorf, Germany
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Essen, Germany
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Mönchengladbach, Germany
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Velbert, Germany
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Dresden, Germany
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Lübeck, 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, India
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Bangalore, India
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Mumbai, India
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Pune, India
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New Delhi, India
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Bhubaneswar, India
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Chennai, India
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Kolkata, 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
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Tlalpan, Mexico
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Monterrey, 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, South Korea
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Gyeonggi-do, South Korea
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Incheon, South Korea
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Seoul, South Korea
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Seoul, 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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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, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Denizli, Turkey (Türkiye)
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Antalya, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Diyarbakır, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Ankara, Turkey (Türkiye)
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Adana, 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)
Trial contact
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Contact information from ClinicalTrials.gov. Contact in English.
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.