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NCT05827081 · ClinicalTrials.gov registry record · Phase 3
Phase IIIb Study of Ribociclib + ET in Early Breast Cancer
A Phase 3 study of Early Breast Cancer, sponsored by Novartis Pharmaceuticals.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 1,400
- Enrollment target
- 20
- Study locations
NCT05827081: Recruiting Phase 3 study of Early Breast Cancer, sponsored by Novartis Pharmaceuticals.
NCT05827081 is a Phase 3 study of Early Breast Cancer that is actively recruiting participants, run by Novartis Pharmaceuticals. The registered enrollment target is 1,400 participants, below the 3,263-participant average among 3 other Early Breast Cancer trials with a reported enrollment target (57% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05827081, a Phase 3 study of Early Breast Cancer, is actively recruiting participants, sponsored by Novartis Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 1,400 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Letrozole
- DRUG Goserelin
- DRUG Ribociclib
- DRUG Leuprolide
- DRUG Ansastrozole
Study Locations (20)
California
- Onco Inst of Hope and Innovation - Cerritos
- City of Hope National Medical - Duarte
- Providence Medical Foundation - Fullerton
- Palo Alto Medical Foundation - Mountain View
- UC Irvine Medical Center - Orange
- Sutter Inst Medical Research - Sacramento
- School Of Medicine - Sacramento
Florida
- Holy Cross Health - Fort Lauderdale
- Memorial Cancer Institute - Hollywood
- Ocala Research Institute, Inc - Ocala
District of Columbia
- Georgetown University Lombardi Cancer Center - Washington D.C.
- Washington Hospital Center - Washington D.C.
Illinois
- Affiliated Oncologists IL - Chicago
- Hope And Healing Care - Hinsdale
Alabama
- Central Alabama Research - Birmingham
Alaska
- Alaska Oncology and Hematology LLC - Anchorage
Arizona
- Western Reg MC-COH Phoenix - Goodyear
Arkansas
- CARTI Cancer Center - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,400 participants |
| Start Date | 2024-02-28 |
| Est. Completion | 2030-09-20 |
| Phase | Phase 3 |
What NCT05827081 shows while recruiting
NCT05827081 is an interventional study that assigns participants to a tested intervention. Its 1,400 participants enrollment target places it among the larger protocols in the corpus, below the 3,263-participant average among 3 other Early Breast Cancer trials with a reported enrollment target (57% lower).
The record links to 1 condition, with Early Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Letrozole is the first listed.
NCT05827081 names 20 study sites across 10 states, led by California, Florida, District of Columbia.
Frequently Asked Questions
What is clinical trial NCT05827081 about?
NCT05827081 is a clinical study titled "Phase IIIb Study of Ribociclib + ET in Early Breast Cancer". 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 ...
What is the current status of trial NCT05827081?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 1,400 participants. The study started on 2024-02-28. Estimated completion is 2030-09-20.
What conditions does trial NCT05827081 study?
This clinical trial studies the following conditions: Early Breast Cancer.
What interventions are being tested in trial NCT05827081?
The interventions under investigation include: Letrozole (DRUG), Goserelin (DRUG), Ribociclib (DRUG), Leuprolide (DRUG), Ansastrozole (DRUG).
Who is sponsoring clinical trial NCT05827081?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05827081 being conducted?
This trial has 20 study locations across Alabama, Alaska, Arizona, Arkansas, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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