Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, HER2-negative, PR positive status confers therapeutic sensitivity to Anastrozole, Goserelin, Ribociclib in patients with Invasive Breast Carcinoma.
The Republic of Ireland's Health Service Executive (HSE) has approved ribociclib in combination with an aromatase inhibitor as a treatment option 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.
This statement is based on a regulatory approval from the Health Service Executive:
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.