Status: Not yet recruiting
Omission of Surgery and Sentinel Lymph Node Dissection in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti- HER2-based Neoadjuvant Therapy (ELPIS Trial)
This is a prospective, single arm, open-label, exploratory study in women with primary operable HER2-positive, HER2-enriched(HER2-E)/ERBB2-high breast cancer according to PAM50 intrinsic subtype and a ERBB2 pre-defined cutoff (high vs low ERBB2 expression), to evaluate the omission of surgery and sentinel lymph node dissection in patients with HER2-E and ERBB2 high breast cancer who achieving a complete response following standard anti-HER2-based neoadjuvant therapy with paclitaxel/trastuzumab/pertuzumab.
Participants needed: 27
Trial details
Phase: Phase 2Age: 40+Biological sex: FemaleType: InterventionalSponsor: David Garcia CincaUpdated: Mar 10, 2020Locations: 1
Eligibility criteria
Female participants who are at least 40 years of age on the day of signing the i... [+18]
A woman of childbearing potential who has a positive urine pregnancy test within... [+25]