Actively Recruiting
Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer
Led by Oana Danciu · Updated on 2026-04-08
200
Participants Needed
20
Research Sites
361 weeks
Total Duration
On this page
Sponsors
O
Oana Danciu
Lead Sponsor
N
Novartis Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an open label, multicenter, single arm phase II study to evaluate the efficacy and safety of ribociclib and ET in patients with locoregional recurrence of HR-positive, HER2-negative breast cancer.
CONDITIONS
Official Title
Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older at time of consent
- Histologically or cytologically confirmed estrogen and/or progesterone receptor-positive breast cancer
- HER2-negative breast cancer confirmed by local laboratory testing
- Locoregional recurrence defined as invasive cancer in the ipsilateral breast, axilla, regional lymph nodes, or chest wall
- Adequate local treatment for recurrence with surgery, radiation, or both
- Enrollment within 6 months of last local treatment (surgery or radiation) or systemic chemotherapy
- ECOG performance status of 0 or 1 within 28 days prior to registration
- Ability to swallow and retain oral medication
- Negative pregnancy test for females of childbearing potential and agreement to use effective contraception
- Adequate organ function according to specified laboratory values
- Ability to understand and comply with study procedures
- No contraindications to the endocrine therapy planned for treatment
You will not qualify if you...
- Known hypersensitivity to ribociclib excipients
- Prior CDK4/6 inhibitor treatment for recurrent disease (adjuvant use allowed if stopped 1 year prior to recurrence)
- Major surgery within 14 days before starting study drug or unresolved major side effects
- Pregnant, breastfeeding, or planning pregnancy during the trial
- Other malignancies that may interfere with safety or efficacy assessments
- Presence of distant metastatic breast cancer beyond regional lymph nodes
- Use of investigational drugs within 30 days prior to registration
- Gastrointestinal diseases affecting drug absorption
- Severe or uncontrolled medical conditions posing safety risks
- Significant uncontrolled heart disease or cardiac abnormalities
- Use of medications or supplements that strongly affect CYP3A4/5 metabolism which cannot be stopped
- Systemic corticosteroid use within 2 weeks prior to study drug start or incomplete recovery from side effects
- Uncontrolled psychiatric conditions impacting safety or compliance
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Actively Recruiting
2
University of Arizona
Phoenix, Arizona, United States, 85004
Actively Recruiting
3
Orlando Health Cancer Institute
Orlando, Florida, United States, 32806
Active, Not Recruiting
4
University of Illinois Cancer Center
Chicago, Illinois, United States, 60612
Actively Recruiting
5
Parkview Research Center
Fort Wayne, Indiana, United States, 46845
Actively Recruiting
6
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Actively Recruiting
7
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Actively Recruiting
8
University of Michigan Health System
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
9
University of Michigan Health-West
Wyoming, Michigan, United States, 49519
Terminated
10
University of Nebraska Medical Center
Omaha, Nebraska, United States, 68198
Actively Recruiting
11
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, United States, 08903
Actively Recruiting
12
University of New Mexico Comprehensive Cancer Center
Albuquerque, New Mexico, United States, 87102
Actively Recruiting
13
New York University Clinical Cancer Center
New York, New York, United States, 10016
Actively Recruiting
14
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Actively Recruiting
15
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Actively Recruiting
16
Penn State Cancer Institute
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
17
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Actively Recruiting
18
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Actively Recruiting
19
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Actively Recruiting
20
University of Wisconsin
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
O
Oana Danciu, MD
CONTACT
A
Amber Ryba
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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