Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing adjuvant Elacestrant with standard endocrine treatment in genomically and/or clinically high-risk ER+/HER2- early breast cancer (ADAPTela)

Condition studied

ER+/HER2- early breast cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

iDFS, compared between patients randomized to adjuvant elacestrant (+/-CDK4/6i) or SOC ET (+/- CDK4/6i)

Endpoint detail

OS defined as time from first diagnosis to death, dDFS, RFS, DFS-DCIS, IBCFS, LRFS, each as defined in STEEP 2.0, Change of HRQoL between baseline, measured after completion of SoC primary treatment (including (neo)adjuvant chemotherapy, surgery, further local therapy), and on following defined timepoints: before start of treatment, 6-monthly during treatment until year 3 and yearly afterwards., Long-term survival endpoints, Survival outcomes in premenopausal patients with N0 + RS 16-25 and N1 + RS 0-25 treated by ovarian function suppression (OFS) in combination with either aromatase inhibitor or tamoxifen (SoC) +/- ribociclib (in stage II) or elacestrant +/- ribociclib (in stage II) without chemotherapy use, Comparison of toxicity of regimen by evaluation of adverse events of special interest (AESI)-, adverse drug reaction (ADR)-, serious adverse drug reaction (SADR)-, and serious adverse event (SAE)-rates.