Ribociclib Therapy (Adjuvant) - 28 day. NCCP National SACT Regimen. HSE.

Regulatory approval published by the Health Service Executive.

Citation

Ribociclib Therapy (Adjuvant) - 28 day, 2025, version number 1b, viewed 01/10/2025, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/breast/892-ribociclib-therapy-adjuvant-28-day.pdf

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication

Statements

In combination with an aromatase inhibitor (AI) is indicated for the adjuvant treatment of patients with hormone receptor positive (HR+), human epidermal growth factor 2 (HER2)-negative early breast cancer at high risk of recurrence. This indication is based on NATALEE (NCT03701334) was a randomized (1:1), open-label, multicenter study, where participants received goserelin and either letrozole or anastrozole, in addition to ribociclib.

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Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	ER positive, HER2-negative	Invasive Breast Carcinoma	Anastrozole, Goserelin, Ribociclib
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Anastrozole, Goserelin, Ribociclib
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Anastrozole, Goserelin, Ribociclib
Sensitivity (+)	ER positive, HER2-negative	Invasive Breast Carcinoma	Goserelin, Letrozole, Ribociclib
Sensitivity (+)	HER2-negative, PR positive	Invasive Breast Carcinoma	Goserelin, Letrozole, Ribociclib
Sensitivity (+)	ER positive, HER2-negative, PR positive	Invasive Breast Carcinoma	Goserelin, Letrozole, Ribociclib