Therapeutic Response

HER2-negative and PR positive status confers therapeutic sensitivity to Anastrozole in combination with Goserelin and Ribociclib in patients with Invasive Breast Carcinoma.

Statements

Source and description
Kisqali (ribociclib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to ribociclib in combination with an aromatase inhibitor for the adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative stage II and III 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.
Kisqali (ribociclib) [product information]. EMA. The European Medicines Agency (EMA) has authorized ribociclib in combination with an aromatase inhibitor for the adjuvant treatment of patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer at high risk of recurrence. In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinising hormone-releasing hormone (LHRH) agonist. 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.
Ribociclib Therapy (Adjuvant) - 28 day. NCCP National SACT Regimen. HSE. 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.