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FEMARA 2

DRUG3 trials

Sponsors

Region Oerebro Laen, Solti Group, Laboratorios Farmaceuticos Rovi S.A.

Conditions

Advanced Breast Cancer in older patientsHER2-negativeHR+/HER2breast cancer to evaluate safety and long-term efficacy of a non-chemo treatment in patients biologically responders to neoadjuvant ribociclib and letrozole.Ki67 #20%Patients with primary operable stage IIgrade 2 or 3inoperable locally advanced or metastatic breast cancer​​​HR-positive

Phase 2

Neoadjuvant and adjuvant RIBOciclib and endocrine therapy for cLinicAlly high-RISk estrogen receptor-positive (ER+) and HER2-negative (HER2-) breast cancer (RIBOLARIS)
Active, not recruitingCTIS2023-508827-10-00
Solti GroupPatients with primary operable stage II, grade 2 or 3, Ki67 #20% +1
Start: 2025-10-13Target: 1100Updated: 2026-01-07

Phase 3

IMPlementing geriatric assessment for dose Optimization of CDK 4/6-inhibitors in older bReasT cAncer patieNTs – a pragmatic randomized-controlled trial (IMPORTANT trial)
RecruitingCTIS2023-506620-87-00
Region Oerebro LaenAdvanced Breast Cancer in older patients
Start: 2024-01-25Target: 495Updated: 2025-07-10
A Multicenter, Randomized, Double-Blind, Double-Dummy, Phase III Study to Evaluate the Efficacy and Safety of Letrozole SIE Compared to Femara® (both in Combination with the CDK4/6 Inhibitor Ribociclib) in Postmenopausal Women with HR-Positive, HER2-Negative, Inoperable Locally Advanced or Metastatic Breast Cancer (SIE-3)
Not yet recruitingCTIS2025-524846-85-00
Laboratorios Farmaceuticos Rovi S.A.​​HR-positive, HER2-negative, inoperable locally advanced or metastatic breast cancer​
Target: 6Updated: 2026-08-21