Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ER positive, HER2-negative, PR positive status confers therapeutic sensitivity to Goserelin, Letrozole, Ribociclib in patients with Invasive Breast Carcinoma.
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. 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.