Actively Recruiting
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
Led by Novartis Pharmaceuticals · Updated on 2026-05-14
1400
Participants Needed
207
Research Sites
342 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult male or female aged 18 years or older at the time of consent
- Histologically or cytologically confirmed estrogen receptor-positive and/or progesterone receptor-positive breast cancer
- HER2-negative breast cancer defined by local laboratory testing
- May have received prior standard neoadjuvant or adjuvant endocrine therapy within 36 months before enrollment
- At least 3 years of endocrine adjuvant therapy remaining
- Restaging recommended if prior endocrine therapy was longer than 12 months to rule out recurrence
- No contraindications to receive adjuvant endocrine therapy
- Completed surgical removal of tumor with clear microscopic margins
- Cancer stage is Anatomic Stage Group III, IIB, or a subset of IIA
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
- Adequate bone marrow and organ function
- QTcF interval on ECG less than 450 milliseconds and resting heart rate between 50 and 99 beats per minute
You will not qualify if you...
- Breast cancer with distant metastases beyond regional lymph nodes or evidence of recurrence after surgery
- Currently using other antineoplastic therapies except adjuvant endocrine therapy
- Severe or uncontrolled medical conditions that increase safety risks or limit compliance
- Clinically significant uncontrolled heart disease or cardiac repolarization abnormalities
- Pregnant, breastfeeding, or planning pregnancy during the trial
- Women of child-bearing potential not using highly effective contraception during and for 21 days after treatment
- Other inclusion/exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 207 locations
1
Central Alabama Research
Birmingham, Alabama, United States, 35209
Actively Recruiting
2
Alaska Oncology and Hematology LLC
Anchorage, Alaska, United States, 99508
Actively Recruiting
3
Western Reg MC-COH Phoenix
Goodyear, Arizona, United States, 85338
Actively Recruiting
4
CARTI Cancer Center
Little Rock, Arkansas, United States, 72205
Actively Recruiting
5
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
Actively Recruiting
6
Onco Inst of Hope and Innovation
Cerritos, California, United States, 90703
Actively Recruiting
7
City of Hope National Medical
Duarte, California, United States, 91010
Actively Recruiting
8
Providence Medical Foundation
Fullerton, California, United States, 92835
Actively Recruiting
9
Palo Alto Medical Foundation
Mountain View, California, United States, 94040
Actively Recruiting
10
UC Irvine Medical Center
Orange, California, United States, 92868
Actively Recruiting
11
Sutter Inst Medical Research
Sacramento, California, United States, 95816-5199
Actively Recruiting
12
School Of Medicine
Sacramento, California, United States, 95817
Actively Recruiting
13
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
Actively Recruiting
14
Georgetown University Lombardi Cancer Center
Washington D.C., District of Columbia, United States, 20007-2197
Actively Recruiting
15
Washington Hospital Center
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
16
Holy Cross Health
Fort Lauderdale, Florida, United States, 33308
Actively Recruiting
17
Hialeah Hospital
Hialeah, Florida, United States, 33013
Actively Recruiting
18
Memorial Cancer Institute
Hollywood, Florida, United States, 33021
Actively Recruiting
19
Ocala Research Institute, Inc
Ocala, Florida, United States, 34474
Actively Recruiting
20
Summit Cancer Care PC
Savannah, Georgia, United States, 31405
Actively Recruiting
21
Hawaii Cancer Care
Honolulu, Hawaii, United States, 96813
Actively Recruiting
22
Affiliated Oncologists IL
Chicago, Illinois, United States, 60415
Actively Recruiting
23
Hope And Healing Care
Hinsdale, Illinois, United States, 60521
Actively Recruiting
24
Midwestern Reg MC COH Chicago
Zion, Illinois, United States, 60099
Actively Recruiting
25
Investigative Clinical R of Indiana
Indianapolis, Indiana, United States, 46260
Actively Recruiting
26
University of Iowa Health Care
Waukee, Iowa, United States, 50263
Actively Recruiting
27
University of Kansas Cancer Center
Westwood, Kansas, United States, 66205
Actively Recruiting
28
Cancer Center of Kansas
Wichita, Kansas, United States, 67214-3728
Actively Recruiting
29
Willis-Knighton Cancer Center
Shreveport, Louisiana, United States, 71103
Actively Recruiting
30
Mercy Medical Center
Baltimore, Maryland, United States, 21202
Actively Recruiting
31
Maryland Oncology Hematology P A
Silver Spring, Maryland, United States, 20904
Actively Recruiting
32
Boston Medical Center
Boston, Massachusetts, United States, 02118
Actively Recruiting
33
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
34
Dana Farber Brigham Women Cancer
Milford, Massachusetts, United States, 01757
Actively Recruiting
35
Minnesota Oncology Hematology P A
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
36
Jackson Oncology Associates
Jackson, Mississippi, United States, 39202
Actively Recruiting
37
HCA Midwest Division
Kansas City, Missouri, United States, 64132
Actively Recruiting
38
WA Uni School Of Med
St Louis, Missouri, United States, 63110
Actively Recruiting
39
Intermountain Healthcare
Billings, Montana, United States, 59102
Actively Recruiting
40
Nebraska Cancer Specialists
Omaha, Nebraska, United States, 68154
Actively Recruiting
41
Renown Regional Medical Center
Reno, Nevada, United States, 89502
Actively Recruiting
42
Cancer Care Specialists
Reno, Nevada, United States, 89511
Actively Recruiting
43
Summit Health
Florham Park, New Jersey, United States, 07932
Actively Recruiting
44
The Valley Hospital
Ridgewood, New Jersey, United States, 07450
Actively Recruiting
45
Presbyterian Medical Group
Albuquerque, New Mexico, United States, 87110
Actively Recruiting
46
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States, 11432
Actively Recruiting
47
Optum Health
Lake Success, New York, United States, 11042
Actively Recruiting
48
Mount Sinai School of Medicine
New York, New York, United States, 10029
Actively Recruiting
49
Duke Cancer Network
Durham, North Carolina, United States, 27710
Actively Recruiting
50
Cone Health Cancer Center
Greensboro, North Carolina, United States, 27403
Actively Recruiting
51
Oncology Associates of Oregon PC
Eugene, Oregon, United States, 97401-8122
Actively Recruiting
52
Northwest Cancer Specialists
Portland, Oregon, United States, 97210
Actively Recruiting
53
Oregon Oncology Specialists Salem
Salem, Oregon, United States, 97301
Actively Recruiting
54
Consultants In Med Onco And Hema
Drexel Hill, Pennsylvania, United States, 19026
Actively Recruiting
55
Univ of Pittsburg Med Ctr Pinnacle
Harrisburg, Pennsylvania, United States, 17109
Actively Recruiting
56
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
Actively Recruiting
57
Bon Secours St Francis Cancer Center
Greenville, South Carolina, United States, 29607
Actively Recruiting
58
Lexington Medical Center
West Columbia, South Carolina, United States, 29169
Actively Recruiting
59
Regional Medical Oncology NC
Wilson, South Carolina, United States, 27893
Actively Recruiting
60
Sanford USD Medical Center
Sioux Falls, South Dakota, United States, 57104
Actively Recruiting
61
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
62
El Paso Texas Oncology
El Paso, Texas, United States, 79902
Actively Recruiting
63
Kelsey Seybold Clinic
Houston, Texas, United States, 77025
Actively Recruiting
64
University of Texas
Houston, Texas, United States, 77030-4099
Actively Recruiting
65
Texas Oncology P A Plano East
Plano, Texas, United States, 75075
Actively Recruiting
66
Texas Oncology PA Tyler
Tyler, Texas, United States, 75702
Actively Recruiting
67
Bon Secours Virginia Health System
Midlothian, Virginia, United States, 23114
Actively Recruiting
68
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Actively Recruiting
69
Kadlec Clinic Hematology and Onco
Kennewick, Washington, United States, 99336
Actively Recruiting
70
Providence Regional Cancer System
Lacey, Washington, United States, 98503
Actively Recruiting
71
Valley Medical Center Research
Renton, Washington, United States, 98055
Actively Recruiting
72
Northwest Medical Specialties
Tacoma, Washington, United States, 98405
Actively Recruiting
73
Novartis Investigative Site
Caba, Buenos Aires, Argentina, C1426ANZ
Actively Recruiting
74
Novartis Investigative Site
La Plata, Buenos Aires, Argentina, B1902CMV
Actively Recruiting
75
Novartis Investigative Site
Córdoba, Argentina, X5004BAL
Actively Recruiting
76
Novartis Investigative Site
Gateshead, New South Wales, Australia, 2290
Actively Recruiting
77
Novartis Investigative Site
Tiwi, Northern Territory, Australia, 810
Actively Recruiting
78
Novartis Investigative Site
Clayton, Victoria, Australia, 3168
Actively Recruiting
79
Novartis Investigative Site
East Melbourne, Victoria, Australia, 3002
Actively Recruiting
80
Novartis Investigative Site
Porto Alegre, Rio Grande do Sul, Brazil, 90560-032
Actively Recruiting
81
Novartis Investigative Site
São Paulo, São Paulo, Brazil, 05652-000
Actively Recruiting
82
Novartis Investigative Site
Victoria, British Columbia, Canada, V8R 6V5
Actively Recruiting
83
Novartis Investigative Site
Halifax, Nova Scotia, Canada, B3H 2Y9
Actively Recruiting
84
Novartis Investigative Site
Oakville, Ontario, Canada, L6M1M1
Actively Recruiting
85
Novartis Investigative Site
Ottawa, Ontario, Canada, K1H 8L6
Actively Recruiting
86
Novartis Investigative Site
Toronto, Ontario, Canada, M4N 3M5
Actively Recruiting
87
Novartis Investigative Site
Montreal, Quebec, Canada, H2X 0A9
Actively Recruiting
88
Novartis Investigative Site
Montreal, Quebec, Canada, H3T 1E2
Actively Recruiting
89
Novartis Investigative Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
90
Novartis Investigative Site
Québec, Quebec, Canada, G1S 4L8
Actively Recruiting
91
Novartis Investigative Site
Saskatoon, Saskatchewan, Canada, S7N 4H4
Actively Recruiting
92
Novartis Investigative Site
Beijing, Beijing Municipality, China, 100044
Actively Recruiting
93
Novartis Investigative Site
Guangzhou, Guangdong, China, 510080
Actively Recruiting
94
Novartis Investigative Site
Harbin, Heilongjiang, China, 150081
Actively Recruiting
95
Novartis Investigative Site
Zhengzhou, Henan, China, 450003
Actively Recruiting
96
Novartis Investigative Site
Zhengzhou, Henan, China, 450008
Actively Recruiting
97
Novartis Investigative Site
Nanjing, Jiangsu, China, 210029
Actively Recruiting
98
Novartis Investigative Site
Nanchang, Jiangxi, China, 330009
Actively Recruiting
99
Novartis Investigative Site
Changchun, Jilin, China, 130021
Actively Recruiting
100
Novartis Investigative Site
Jinan, Shandong, China, 250021
Actively Recruiting
101
Novartis Investigative Site
Jinan, Shandong, China, 250117
Actively Recruiting
102
Novartis Investigative Site
Jining, Shandong, China, 272000
Actively Recruiting
103
Novartis Investigative Site
Chengdu, Sichuan, China, 610041
Actively Recruiting
104
Novartis Investigative Site
Chengdu, Sichuan, China, 610072
Actively Recruiting
105
Novartis Investigative Site
Ürümqi, Xinjiang, China, 830000
Actively Recruiting
106
Novartis Investigative Site
Hangzhou, Zhejiang, China, 310006
Actively Recruiting
107
Novartis Investigative Site
Hangzhou, Zhejiang, China, 310022
Actively Recruiting
108
Novartis Investigative Site
Wenzhou, Zhejiang, China, 325000
Actively Recruiting
109
Novartis Investigative Site
Beijing, China, 100039
Actively Recruiting
110
Novartis Investigative Site
Beijing, China, 100730
Actively Recruiting
111
Novartis Investigative Site
Guangzhou, China, 510060
Actively Recruiting
112
Novartis Investigative Site
Qingdao, China, 266000
Actively Recruiting
113
Novartis Investigative Site
Shanghai, China, 200032
Actively Recruiting
114
Novartis Investigative Site
Shijiazhuang, China, 050035
Actively Recruiting
115
Novartis Investigative Site
Tianjin, China, 300480
Actively Recruiting
116
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
117
Novartis Investigative Site
Munich, Bavaria, Germany, 81377
Actively Recruiting
118
Novartis Investigative Site
Regensburg, Bavaria, Germany, 93053
Actively Recruiting
119
Novartis Investigative Site
Weiden in Der Oberpfalz, Bavaria, Germany, 92637
Actively Recruiting
120
Novartis Investigative Site
Langen, Hesse, Germany, 63225
Actively Recruiting
121
Novartis Investigative Site
Hildesheim, Lower Saxony, Germany, 31134
Withdrawn
122
Novartis Investigative Site
Bergisch Gladbach, North Rhine-Westphalia, Germany, 51465
Actively Recruiting
123
Novartis Investigative Site
Bielefeld, North Rhine-Westphalia, Germany, 33604
Withdrawn
124
Novartis Investigative Site
Düsseldorf, North Rhine-Westphalia, Germany, 40225
Withdrawn
125
Novartis Investigative Site
Essen, North Rhine-Westphalia, Germany, 45136
Actively Recruiting
126
Novartis Investigative Site
Mönchengladbach, North Rhine-Westphalia, Germany, 41061
Actively Recruiting
127
Novartis Investigative Site
Velbert, North Rhine-Westphalia, Germany, 42551
Actively Recruiting
128
Novartis Investigative Site
Dresden, Saxony, Germany, 01307
Actively Recruiting
129
Novartis Investigative Site
Lübeck, Schleswig-Holstein, Germany, 23563
Withdrawn
130
Novartis Investigative Site
Augsburg, Germany, 86150
Withdrawn
131
Novartis Investigative Site
Augsburg, Germany, 86179
Actively Recruiting
132
Novartis Investigative Site
Berlin, Germany, 10967
Actively Recruiting
133
Novartis Investigative Site
Berlin, Germany, 13125
Actively Recruiting
134
Novartis Investigative Site
Bottrop, Germany, 46236
Actively Recruiting
135
Novartis Investigative Site
Böblingen, Germany, 71032
Withdrawn
136
Novartis Investigative Site
Dessau, Germany, 06847
Actively Recruiting
137
Novartis Investigative Site
Erlangen, Germany, 91054
Actively Recruiting
138
Novartis Investigative Site
Essen, Germany, 45147
Actively Recruiting
139
Novartis Investigative Site
Hamburg, Germany, 20246
Withdrawn
140
Novartis Investigative Site
Kiel, Germany, 24105
Actively Recruiting
141
Novartis Investigative Site
Leipzig, Germany, 04277
Actively Recruiting
142
Novartis Investigative Site
Mainz, Germany, 55131
Withdrawn
143
Novartis Investigative Site
München, Germany, 80637
Actively Recruiting
144
Novartis Investigative Site
Ravensburg, Germany, 88214
Actively Recruiting
145
Novartis Investigative Site
Hong Kong, Hong Kong, 999077
Actively Recruiting
146
Novartis Investigative Site
Kowloon, Hong Kong, 999077
Actively Recruiting
147
Novartis Investigative Site
Tuenmen, Hong Kong, 999077
Actively Recruiting
148
Novartis Investigative Site
Hyderabad, Andhra Pradesh, India, 500034
Active, Not Recruiting
149
Novartis Investigative Site
Bangalore, Karnataka, India, 560017
Active, Not Recruiting
150
Novartis Investigative Site
Mumbai, Maharashtra, India, 400 012
Active, Not Recruiting
151
Novartis Investigative Site
Pune, Maharasthra, India, 411028
Active, Not Recruiting
152
Novartis Investigative Site
New Delhi, National Capital Territory of Delhi, India, 110029
Active, Not Recruiting
153
Novartis Investigative Site
Bhubaneswar, Odisha, India, 751007
Active, Not Recruiting
154
Novartis Investigative Site
Chennai, Tamil Nadu, India, 600 035
Active, Not Recruiting
155
Novartis Investigative Site
Kolkata, West Bengal, India, 700054
Active, Not Recruiting
156
Novartis Investigative Site
Ahmedabad, India, 380054
Active, Not Recruiting
157
Novartis Investigative Site
Beersheba, Israel, 8457108
Actively Recruiting
158
Novartis Investigative Site
Petah Tikva, Israel, 4941492
Actively Recruiting
159
Novartis Investigative Site
Ramat Gan, Israel, 5265601
Actively Recruiting
160
Novartis Investigative Site
Tel Aviv, Israel, 6423906
Actively Recruiting
161
Novartis Investigative Site
Alc Cuahutemoc, Mexico City, Mexico, 06720
Actively Recruiting
162
Novartis Investigative Site
Tlalpan, Mexico City, Mexico, 14080
Actively Recruiting
163
Novartis Investigative Site
Monterrey, Nuevo León, Mexico, 64460
Actively Recruiting
164
Novartis Investigative Site
Coimbra, Portugal, 3000-075
Actively Recruiting
165
Novartis Investigative Site
Lisbon, Portugal, 1400-038
Actively Recruiting
166
Novartis Investigative Site
Lisbon, Portugal, 1649-035
Actively Recruiting
167
Novartis Investigative Site
Porto, Portugal, 4100-180
Actively Recruiting
168
Novartis Investigative Site
Porto, Portugal, 4200 319
Actively Recruiting
169
Novartis Investigative Site
Porto, Portugal, 4200-072
Actively Recruiting
170
Pan Oncology
Rio Piedras, Puerto Rico, 00935
Actively Recruiting
171
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, South Korea, 13620
Actively Recruiting
172
Novartis Investigative Site
Gyeonggi-do, Korea, South Korea, 10408
Actively Recruiting
173
Novartis Investigative Site
Incheon, Korea, South Korea, 405 760
Actively Recruiting
174
Novartis Investigative Site
Seoul, Korea, South Korea, 02841
Actively Recruiting
175
Novartis Investigative Site
Seoul, Yangcheon Gu, South Korea, 07985
Actively Recruiting
176
Novartis Investigative Site
Seongnam Gyeonggi, South Korea, 463-712
Actively Recruiting
177
Novartis Investigative Site
Seoul, South Korea, 03080
Actively Recruiting
178
Novartis Investigative Site
Seoul, South Korea, 03722
Actively Recruiting
179
Novartis Investigative Site
Seoul, South Korea, 05505
Actively Recruiting
180
Novartis Investigative Site
Seoul, South Korea, 06273
Actively Recruiting
181
Novartis Investigative Site
Seoul, South Korea, 06351
Actively Recruiting
182
Novartis Investigative Site
Seoul, South Korea, 06591
Actively Recruiting
183
Novartis Investigative Site
Hualien City, Taiwan, 970
Actively Recruiting
184
Novartis Investigative Site
Kaohsiung City, Taiwan, 80756
Actively Recruiting
185
Novartis Investigative Site
Tainan, Taiwan, 71004
Actively Recruiting
186
Novartis Investigative Site
Taipei, Taiwan, 10002
Actively Recruiting
187
Novartis Investigative Site
Taipei, Taiwan, 114
Actively Recruiting
188
Novartis Investigative Site
Sakarya, Adapazari, Turkey (Türkiye), 54290
Actively Recruiting
189
Novartis Investigative Site
Ankara, Bilkent-Cankaya, Turkey (Türkiye), 06800
Actively Recruiting
190
Novartis Investigative Site
Istanbul, Fatih, Turkey (Türkiye), 34098
Actively Recruiting
191
Novartis Investigative Site
Istanbul, Kadikoy, Turkey (Türkiye), 34722
Actively Recruiting
192
Novartis Investigative Site
Izmir, Karsiyaka, Turkey (Türkiye), 35575
Actively Recruiting
193
Novartis Investigative Site
Denizli, Kinikli, Turkey (Türkiye), 20070
Actively Recruiting
194
Novartis Investigative Site
Antalya, Konyaalti, Turkey (Türkiye), 07070
Actively Recruiting
195
Novartis Investigative Site
Istanbul, Sariyer, Turkey (Türkiye), 34457
Actively Recruiting
196
Novartis Investigative Site
Ankara, Sihhiye-Altindag, Turkey (Türkiye), 06230
Actively Recruiting
197
Novartis Investigative Site
Diyarbakır, Sur, Turkey (Türkiye), 21280
Actively Recruiting
198
Novartis Investigative Site
Istanbul, Uskudar, Turkey (Türkiye), 34662
Actively Recruiting
199
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye), 06200
Actively Recruiting
200
Novartis Investigative Site
Ankara, Yenimahalle, Turkey (Türkiye), 06500
Actively Recruiting
201
Novartis Investigative Site
Adana, Yuregir, Turkey (Türkiye), 01230
Actively Recruiting
202
Novartis Investigative Site
Ankara, Turkey (Türkiye), 06520
Actively Recruiting
203
Novartis Investigative Site
Istanbul, Turkey (Türkiye), 34147
Actively Recruiting
204
Novartis Investigative Site
Izmir, Turkey (Türkiye), 35100
Actively Recruiting
205
Novartis Investigative Site
Kecioren Ankara, Turkey (Türkiye), 06010
Actively Recruiting
206
Novartis Investigative Site
Konya, Turkey (Türkiye), 42080
Actively Recruiting
207
Novartis Investigative Site
Samsun, Turkey (Türkiye), 55200
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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