Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Behaviors and Mental Disorders

Breast Neoplasms

Behavior, Addictive

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Paclitaxel

Albumin-Bound Paclitaxel

Trastuzumab

Pertuzumab

Tubulin Modulators

Antimitotic Agents

Antineoplastic Agents, Immunological

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

Pertuzumab and trastuzumab FDC subcutaneous

80 mg/m2, day 1,8,15 of each 3 week cycle during 4 cycles

3,6 mg/kg, 14 adjuvant cycles if not complete response

TDM1

Adjuvant endocrine therapy will be administered as per local practice and according to recognized clinical practice guidelines

Endocrine therapy

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

Omission surgery

Nuria Chic, MD

Aleix Pratts

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.

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)

To estimate the loco-regional invasive disease-free survival at 3-year of patients who achieve a complete response based on imaging and a stereotactic-guided vacuum-assisted breast biopsy, and omit loco-regional surgery. 3-years loco-regional invasive disease-free survival rate is defined as time from the first date of no disease (i.e., date of stereotaxic guided biopsy) to loco-regional recurrence. Loco-regional recurrence is defined as recurrence of breast cancer in the same breast parenchyma as the original primary lesion, the axilla, regional lymph nodes, chest wall and/or skin of the ipsilateral breast.

European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30), version 3; 3.2 EORTC QLQ-BR23 (breast cancer-specific questionnaire). There are all scale with a range that goes from 0 to 100 were 0 is the worst result and 100 the best.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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)	NCT04301375	Mammary Cancer	Pertuzumab and ... Paclitaxel TDM1 Endocrine thera... Omission surger...	40 Years -	Hospital Clinic of Barcelona
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)	NCT04301375	Mammary Cancer	Pertuzumab and ... Paclitaxel TDM1 Endocrine thera... Omission surger...	40 Years -	Hospital Clinic of Barcelona

Spots Global Cancer Trial Database for pertuzumab and trastuzumab fdc subcutaneous