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Clinical trial for the treatment of pre- and postmenopausal women and men with locally advanced or metastatic ERﱱ breast cancer with an ESR1 mutation
THE OBJECTIVE IS TO EVALUATE THE PROGRESSION-FREE SURVIVAL (PFS) OF THE COMBINATION OF LASOFOXIFENE AND ABEMACICLIB COMPARED WITH FULVESTRANT AND ABEMACICLIB FOR THE TREATMENT OF PREMENOPAUSAL AND POSTMENOPAUSAL WOMEN AND MEN WHO HAVE PREVIOUSLY RECEIVED RIBOCICLIB- OR PALBOCICLIB-BASED THERAPY AND HAVE LOCALLY ADVANCED OR METASTATIC ESTROGEN RECEPTOR-POSITIVE (ER)/HUMAN EPIDERMAL GROWTH FACTOR 2-NEGATIVE (HER2)-POSITIVE (HER2)-POSITIVE BREAST CANCER WITH ESTROGEN RECEPTOR-POSITIVE (HER2)-POSITIVE PROSTATE CANCER. LOCALLY ADVANCED OR METASTATIC ESTROGEN RECEPTOR (ER)/HUMAN EPIDERMAL GROWTH FACTOR 2 NEGATIVE (HER2)-POSITIVE BREAST CANCER WITH PROSTATE CANCER. (HER2)-POSITIVE BREAST CANCER WITH AN ESTROGEN RECEPTOR 1 (ESR1) MUTATION.
Technical Summary
- MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY COMPARING THE EFFICACY AND SAFETY OF THE COMBINATION OF LASOFOXIFENE AND ABEMACICLIB WITH THE COMBINATION OF FULVESTRANT AND ABEMACICLIB FOR THE TREATMENT OF PRE- AND POSTMENOPAUSAL WOMEN AND MEN WITH LOCALLY ADVANCED OR METASTATIC ERﱱ BREAST CANCER WITH AN ESR1 MUTATION
- Code EudraCT: 2023-503708-10
- Protocol number: SMX 22-002
- Promoter: Sermomix Pharmaceuticals
- Molecule/Drug: Lasofoxifeno y abemaciclib con la combinación de fulvestrant y abemaciclib.
* The trials only admit a limited number of patients and are subject to inclusion and exclusion criteria. The specialist who assesses your case will inform you of the conditions required to participate in the clinical trial.
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