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Study for ER-Positive, HER2-Negative Breast Cancer with Ribociclib and Endocrine Therapy

This study is for people with ER-positive, HER2-negative breast cancer that has been removed by surgery. It's looking at whether patients can choose to skip chemotherapy while still receiving ribociclib (a targeted therapy) and endocrine therapy (hormone therapy like letrozole, anastrozole, or goserelin). You would be eligible if you are 18 or older, male or female, and have certain characteristics of your cancer, including specific HER2 and MET biomarker results. The main goal is to see how many people stop taking ribociclib within one year. The study plans to enroll 140 participants.

Study design
This is a Phase II study where 140 participants will choose between two treatment arms: one with ribociclib and endocrine therapy, and one with chemotherapy followed by ribociclib and endocrine therapy.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured within one year of treatment, focusing on the discontinuation rate of ribociclib.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06953882

Impact of Omitting Chemo Based on Patient's Selection for ER-Positive, HER2-Negative Breast Cancer With Ribociclib and Endocrine Therapy

Recruiting
PHASE2Ages 18+InterventionalTreatment
Yale University
~140 participants
Updated 2026-05-26 on ClinicalTrials.gov
What's tested:Ribociclib 400mgLetrozole 2.5mgAnastrazole 1mgGoserelin 3.6 MGAdjuvant chemotherapy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Discontinuation rate of ribociclib in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancer
Measured over Within one year of treatment

Conditions

HER2 Negative Breast Cancer

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Connecticut1

Study leadership

  • Jing Du · PRINCIPAL_INVESTIGATOR · Yale University

Who to contact

Stephanie Ladd
[email protected]
954-895-0576
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Potassium.
Magnesium.
Total Calcium (corrected for serum albumin). 14. Standard 12-lead ECG values assessed as: QTcF interval (using Fridericia's correction) at screening \< 450 msec. Resting heart rate 50-90 beats per minute (determined from the ECG). 15. Participant must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures. 16. Participants must adhere to the following reproductive and contraceptive requirements while on study treatment and within three months after receiving the last dose of the treatment drugs.

What this trial measures

  • Discontinuation rate of ribociclib in patients with resected moderate to high-anatomical risk, low-genomic risk, ER-positive, HER2-negative breast cancerWithin one year of treatment

    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 (e.g., adverse events, disease recurrence, patient/investigator decision, lost to follow up, etc).