Not Yet RecruitingPhase 2

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)

Spain27 participantsStarted 2020-06-15

Plain-language 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.

Who can participate

Age range40 Years

SexFEMALE

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Inclusion criteria

✓. Not a woman of childbearing potential as defined in protocol OR
✓. A woman of childbearing potential who agrees to follow the contraceptive guidance in protocol during the treatment period and for at least 7 months after the last dose of study treatment

What they're measuring

To estimate the loco-regional invasive disease-free survival of patients who achieve a complete response

Timeframe: 3 years

Trial details

NCT IDNCT04301375

SponsorDavid Garcia Cinca

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-15

Contact for this trial

Nuria Chic, MD

CHIC@clinic.cat

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