drugset / Trial / NCT04301375
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)
Phase 2
Not yet recruiting
27 enrolled
David Garcia Cinca
Fundacion Clinic per a la Recerca Biomédica · collab
NaSingle-groupOpen-labelTreatment
Summary
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.
Timeline
- Start
- 2020-06-15
- Primary completion
- 2027-07-15
- Completion
- 2027-07-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Paclitaxel | Small molecule | 80 mg/m2 | — |
| Background | Pertuzumab | Monoclonal antibody | 600 mg | Subcutaneous |
| Background | Trastuzumab | Monoclonal antibody | 600 mg | Subcutaneous |
| Background | Trastuzumab emtansine | Other / unclassified | 3.6 mg/kg | — |