RecruitingPhase 2NCT06953882

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

SELECT: A Phase II Adjuvant Trial Evaluating the Impact of Omitting Chemotherapy Based on Patient's Selection for Moderate to High-Anatomical Risk, Low-Genomic Risk, ER-Positive, HER2- Negative Breast Cancer With a Combination Regimen of Ribociclib and Optimized Endocrine Therapy


Sponsor

Yale University

Enrollment

140 participants

Start Date

Jul 9, 2025

Study Type

INTERVENTIONAL

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study looks at whether certain breast cancer patients with hormone receptor-positive, HER2-negative cancer (the most common breast cancer type) can safely skip chemotherapy and do just as well with hormone-blocking therapy alone. Researchers are studying patients whose genomic tumor test results suggest a low risk of cancer returning. **You may be eligible if...** - You are 18 or older with ER-positive, HER2-negative breast cancer - You had breast-conserving surgery (lumpectomy) or a mastectomy with clear margins - You had a sentinel lymph node biopsy or axillary lymph node dissection - Your tumor characteristics (stage and gene expression score) suggest low risk of recurrence - You plan to take hormone-blocking therapy (such as tamoxifen or an aromatase inhibitor) for at least 5 years **You may NOT be eligible if...** - Your cancer has spread to distant parts of the body (stage IV) - You have an inflammatory breast cancer or a very large tumor (T4) - You have already received chemotherapy or targeted biologic therapy before surgery - You have taken hormone-blocking drugs in the past 2 years for cancer prevention Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGRibociclib 400mg

400 mg (2 x 200 mg tablets by mouth) once daily on days 1 to 21 of a 28-day cycle, followed by seven days off ribociclib (Days 22 to 28).

DRUGLetrozole 2.5mg

Letrozole will be administered as an endocrine therapy. The regimen will differ depending on the demographic of the patient. For postmenopausal women: Letrozole 2.5 mg by mouth daily continuously. For men or premenopausal women: Letrozole 2.5 mg by mouth daily continuously.

DRUGAnastrazole 1mg

For postmenopausal women: Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously. For men or premenopausal women: Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously.

DRUGGoserelin 3.6 MG

For men or premenopausal women: Letrozole 2.5 mg by mouth daily continuously or anastrozole 1 mg by mouth daily continuously, concurrently with goserelin 3.6 mg monthly injection.

RADIATIONAdjuvant chemotherapy

Adjuvant chemotherapy dose modifications in Arm 2 will be per institutional guidelines and investigator discretion.


Locations(1)

Yale University

New Haven, Connecticut, United States

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NCT06953882