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, two-arm, single center, patient preference study designed to evaluate the impact of omitting adjuvant chemotherapy in 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),

Trial Details

NCT ID

NCT06953882

Phase

PHASE2

Sponsor

Yale University

Status

RECRUITING

Cancer Type

Breast Cancer

Interventions

Ribociclib 400mg
Letrozole 2.5mg
Anastrazole 1mg
Goserelin 3.6 MG
Adjuvant chemotherapy

Locations (sample)

New Haven, Connecticut, United States|41.30815,-72.92816

Key Eligibility Criteria

Female or male age ≥ 18 years old and have the ability to understand and the willingness to sign a written informed consent document.
Participants may have ipsilateral or contralateral synchronous breast cancer if the highest stage tumor meets entry criteria, and the other sites o…
Participants may have multicentric or multifocal breast cancer if the highest stage tumor meets entry criteria, and the other sites of disease woul…
Participants underwent a total mastectomy, skin-sparing mastectomy, nipple-sparing mastectomy, or a lumpectomy.

For full eligibility, visit ClinicalTrials.gov.

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