Actively Recruiting
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Led by Novartis Pharmaceuticals · Updated on 2026-04-27
280
Participants Needed
33
Research Sites
181 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Phase I: Characterize safety and tolerability of ECI830 as a single agent and in combination with ribociclib and fulvestrant. Identify dose range for optimization/recommended dose for future studies. Phase II: Assess the anti-tumor activity of ECI830 in combination with ribociclib and fulvestrant in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced breast cancer.
CONDITIONS
Official Title
Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Diagnosis of advanced hormone receptor-positive, HER2-negative breast cancer or advanced solid tumors with CCNE1 amplification
- For Phase I: Breast cancer patients with disease progression after hormone therapy plus CDK4/6 inhibitor and at least one additional systemic therapy
- For Phase I dose expansion: No more than 3 prior lines of therapy for advanced disease
- For Phase II: Breast cancer patients with progression on aromatase inhibitor or tamoxifen plus CDK4/6 inhibitor with no more than 2 lines of endocrine therapy
- Measurable disease by RECIST v1.1 or at least one lytic bone lesion suitable for repeated assessment if no measurable disease
You will not qualify if you...
- Prior treatment with a CDK2 inhibitor
- Inadequate bone marrow or organ function based on lab values
- Clinically significant uncontrolled heart disease or cardiac repolarization abnormalities
- Symptomatic central nervous system metastases or those requiring recent local therapy or increased corticosteroids
- For combination treatment: Symptomatic visceral disease or disease making endocrine therapy unsuitable
- Previous intolerance to prescribed ribociclib dose requiring dose reduction or permanent discontinuation
- Concurrent hormone replacement therapy in breast cancer patients
- Women of childbearing potential unwilling to use effective contraception, pregnant or nursing
- Other criteria as defined in the study protocol
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 33 locations
1
University of California LA
Los Angeles, California, United States, 90095
Actively Recruiting
2
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
Actively Recruiting
3
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Actively Recruiting
4
WA Uni School Of Med
St Louis, Missouri, United States, 63110
Actively Recruiting
5
Memorial Sloan Kettering
New York, New York, United States, 10017
Actively Recruiting
6
SCRI Oncology Partners
Nashville, Tennessee, United States, 37203
Actively Recruiting
7
MD Anderson Cancer Center Uni of Te
Houston, Texas, United States, 77030
Actively Recruiting
8
Fred Hutch Cancer Research
Seattle, Washington, United States, 98109
Actively Recruiting
9
Novartis Investigative Site
Clayton, Victoria, Australia, 3168
Actively Recruiting
10
Novartis Investigative Site
Melbourne, Victoria, Australia, 3004
Actively Recruiting
11
Novartis Investigative Site
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
12
Novartis Investigative Site
Montreal, Quebec, Canada, H4A 3J1
Actively Recruiting
13
Novartis Investigative Site
Nanjing, Jiangsu, China, 210029
Actively Recruiting
14
Novartis Investigative Site
Xian, Shanxi, China, 710061
Actively Recruiting
15
Novartis Investigative Site
Brno, Czechia, 656 53
Actively Recruiting
16
Novartis Investigative Site
Copenhagen, Denmark, DK-2100
Actively Recruiting
17
Novartis Investigative Site
Odense C, Denmark, 5000
Actively Recruiting
18
Novartis Investigative Site
Bordeaux, France, 33076
Actively Recruiting
19
Novartis Investigative Site
Saint-Herblain, France, 44805
Actively Recruiting
20
Novartis Investigative Site
Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
Actively Recruiting
21
Novartis Investigative Site
Heidelberg, Germany, 69120
Actively Recruiting
22
Novartis Investigative Site
Ulm, Germany, 89081
Actively Recruiting
23
Novartis Investigative Site
Haifa, Israel, 3109601
Actively Recruiting
24
Novartis Investigative Site
Tel Aviv, Israel, 6423906
Actively Recruiting
25
Novartis Investigative Site
Modena, MO, Italy, 41124
Actively Recruiting
26
Novartis Investigative Site
Milan, Italy, 20141
Actively Recruiting
27
Novartis Investigative Site
Chuo Ku, Tokyo, Japan, 1040045
Actively Recruiting
28
Novartis Investigative Site
Singapore, Singapore, 119074
Actively Recruiting
29
Novartis Investigative Site
Seoul, South Korea, 03080
Actively Recruiting
30
Novartis Investigative Site
Barcelona, Spain, 08035
Actively Recruiting
31
Novartis Investigative Site
Barcelona, Spain, 08036
Actively Recruiting
32
Novartis Investigative Site
Tainan, Taiwan, 704
Actively Recruiting
33
Novartis Investigative Site
London, Oxford, United Kingdom, OX3 7LE
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
6
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