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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 27 (estimated)
• Sponsor: David Garcia Cinca · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mammary Cancer

Interventions

Type	Name	Description
DRUG	Pertuzumab and trastuzumab FDC subcutaneous	Pertuzumab and trastuzumab FDC subcutaneous, A loading dose of 1200 mg pertuzumab and 600 mg trastuzumab followed by a maintenance dose of 600 mg pertuzumab and 600 mg; day 1 of each 3 week cycle during 5 neoadjuvant cycles and 13 adjuvant cycles if complete response
DRUG	Paclitaxel	80 mg/m2, day 1,8,15 of each 3 week cycle during 4 cycles
DRUG	TDM1	3,6 mg/kg, 14 adjuvant cycles if not complete response
DRUG	Endocrine therapy	Adjuvant endocrine therapy will be administered as per local practice and according to recognized clinical practice guidelines
PROCEDURE	Omission surgery	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 date: 2020-06-15
• Primary completion: 2027-07-15
• Completion: 2027-07-15
• First posted: 2020-03-10
• Last updated: 2020-03-10

Locations

1 site across 1 country: Spain