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NCT06953882 · ClinicalTrials.gov registry record · Phase 2
Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy
A Phase 2 study of HER2-Negative Breast Cancer, sponsored by Yale University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT06953882: Recruiting Phase 2 study of HER2-Negative Breast Cancer, sponsored by Yale University.
NCT06953882 is a Phase 2 study of HER2-Negative Breast Cancer that is actively recruiting participants, run by Yale University. The registered enrollment target is 140 participants, below the 252-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06953882, a Phase 2 study of HER2-Negative Breast Cancer, is actively recruiting participants, sponsored by Yale University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a Phase II Trial to assess the impact of omitting adjuvant chemotherapy based on patient's selection on treatment persistence of CDK4/6 inhibitor, ribociclib (Kisqali), in a well-defined subgroup of patients with resected estrogen receptor (ER)-positive, HER2-negative, lymph node-positive breast cancer, but whose tumor profiling indicates a less aggressive biological nature (OncotypeDx 21-gene recurrence score RS 0-25).
Primary Outcome
Discontinuation rate of ribociclib in participants with resected moderate to high-anatomical risk, low-genomic risk (men or premenopausal women T2-3N0 and RS 16-25, or T1-3N1-2 and RS ≤ 25, and postmenopausal women T2-3N0 and RS 26-30, or T1-3N1 and RS 26-30, or T1-3N2 and RS ≤ 25), ER-positive, HER2-negative breast cancer who choose to forgo adjuvant chemotherapy in their treatment regimen. One-year treatment discontinuation is defined as treatment discontinuation within one year for any reason
Conditions Studied
Interventions
- DRUG Ribociclib 400mg
- DRUG Letrozole 2.5mg
- DRUG Anastrazole 1mg
- DRUG Goserelin 3.6 MG
- RADIATION Adjuvant chemotherapy
Study Locations (1)
Connecticut
- Yale University - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2025-07-09 |
| Est. Completion | 2030-09 |
| Phase | Phase 2 |
What NCT06953882 shows while recruiting
NCT06953882 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, below the 252-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (44% lower).
The record links to 1 condition, with HER2-Negative Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Ribociclib 400mg is the first listed.
NCT06953882 reports a single indexed study location in Connecticut.
Frequently Asked Questions
What is clinical trial NCT06953882 about?
NCT06953882 is a clinical study titled "Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy". This is a Phase II Trial to assess the impact of omitting adjuvant chemotherapy based on patient's selection on treatment persistence of CDK4/6 inhibitor, ribociclib (Kisqali), in a well-defined subgroup of patients with resected estrogen receptor (ER)-positive, HER2-negative, lymph node-positive br...
What is the current status of trial NCT06953882?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2025-07-09. Estimated completion is 2030-09.
What conditions does trial NCT06953882 study?
This clinical trial studies the following conditions: HER2-Negative Breast Cancer.
What interventions are being tested in trial NCT06953882?
The interventions under investigation include: Ribociclib 400mg (DRUG), Letrozole 2.5mg (DRUG), Anastrazole 1mg (DRUG), Goserelin 3.6 MG (DRUG), Adjuvant chemotherapy (RADIATION).
Who is sponsoring clinical trial NCT06953882?
This trial is sponsored by Yale University, which has 1,492 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06953882 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2-Negative Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06953882's enrollment target sits among peer trials
140 14th of 49 higher than 36 of 49 other HER2-Negative Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2-Negative Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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