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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 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.

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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).

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

FieldValue
Enrollment Target 140 participants
Start Date 2025-07-09
Est. Completion 2030-09
Phase Phase 2

Sponsor

Yale University

1,492 total trials

What the Registry Record Tells You About NCT06953882

The ClinicalTrials.gov registry entry for NCT06953882 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 140 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 252-participant average among 49 other HER2-Negative Breast Cancer trials with a reported enrollment target (44% lower). The listed sponsor is Yale University, which has 1,492 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.