Omission of Surgery in Clinically Low-risk HER2positive Breast Cancer With High HER2 Addiction and a Complete Response Following Standard Anti-HER2-based Neoadjuvant Therapy

PHASE2RecruitingINTERVENTIONAL
Enrollment

17

Participants

Timeline

Start Date

September 23, 2020

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
HER2-positive Breast CancerStage I Breast Cancer
Interventions
BIOLOGICAL

Trastuzumab and pertuzumab Subcutaneous Fixed-Dose Combination

After 13 weeks of neoadjuvant treatment, a breast MRI will be performed. If a complete response is observed on breast MRI, patients will undergo a stereotactic-guided VAB of the marker area to obtain 12 cylinders of breast parenchyma, which is equivalent to 2 grams of tissue. If no invasive tumor cells and no in situ disease are identified in the stereotactic-guided VAB, patients will be eligible to omit loco-regional surgery.

Trial Locations (1)

08036

RECRUITING

Hospital Clinic de Barcelona, Barcelona

All Listed Sponsors
collaborator

SOLTI Breast Cancer Research Group

OTHER

collaborator

Roche Pharma AG

INDUSTRY

lead

Fundacio Clinic Barcelona

OTHER