Study Name: GENENTECH ML43171 (evERA)

Recruiting

Breast

• Patients with ER- positive, HER2- negative, locally advanced or metastatic breast cancer who HAVE received prior CDK4/6i and ET offered to both Male and Female

GENENTECH ML43171 (evERA): A phase III, Randomized, Open-Label, study evaluating the efficacy and safety of GIREDESTARANT + ET of physicians’ choice, compared with EXEMESTANE +EVEROLIMUS in Patients with ER- positive, HER2- negative, locally advanced or metastatic breast cancer who HAVE received prior CDK4/6i and ET offered to both Male and Female

NCT#05306340

clinicaltrials.gov/show/NCT05306340

Male and Female – 18 years and older

• Locally advance unresectable, or metastatic adenocarcinoma of breast, NOT amenable to tx with curative intent
• Histo or cytologically, locally confirmed ER+ and HER2 – status.
• Must be considered appropriate for Endocrine Therapy
• Prior ET with CDK4/6 inhibitor in either setting as follows:
• Metastatic: Disease progression ≥6 months after initiating ET + CDK4/6i in the LA or metastatic setting. If ET + CDK 4/6i isn’t most recent therapy, pt must also have PD after ≥4 months on most recent ET
• Adjuvant: Relapse while taking or within 12 months of exposure to adjuvant ET and CDK4/6i. Pts must have taken at least 12 months of adj ET, 6 months of which was in combination with a CDK4/6i
• Measurable disease per RECIST 1.1, or evaluable bone metastases

• Prior tx with another oral SERD, PROTAC, CERAN or SERM  Or everolimus in any setting
• Prior Fulvestrant IS allowed if tx was terminated at least 28 days prior to randomization
• No more than 2 prior lines of ET in the LA or mBC setting
• Prior chemo for locally advance unresectable, or metastatic disease
• No major surgery, chemo, RT, or anti-cancer therapy w/in 14 days prior to randomization