Not Yet RecruitingPhase 2

Pragmatic Study to Optimize Neoadjuvant Treatment and Surgical De-escalation in HR+/HER2- Early Breast Cancer Using Oncotype DX and Abemaciclib

Italy150 participantsStarted 2026-04-30

Plain-language summary

This is a pragmatic phase 2 study to determine the proportion of patients with ER+ (≥10%)/HER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the initial diagnostic biopsy and according to the MDT decision and to evaluate the proportion of patients undergoing breast conservative surgery and/or sentinel node biopsy

Who can participate

Age range18 Years – 90 Years

SexFEMALE

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Exclusion criteria

✕. basal or squamous cell carcinoma of the skin,
✕. melanoma in situ,
✕. in situ non-breast carcinoma without invasion,
✕. contra- or ipsilateral in situ breast carcinoma,
✕. non-breast invasive malignancy diagnosed at least 5 years ago and without recurrence,
✕. stage I papillary thyroid cancer,
✕. stage Ia carcinoma of the cervix,
✕. stage Ia or b endometrioid endometrial cancer,

What they're measuring

determine the proportion of patients with ER+ (≥10%)/HER2- EBC in whom neoadjuvant chemotherapy can be replaced by NET plus abemaciclib based on the results of the ODX RS obtained in the initial diagnostic biopsy and according to the MDT decision

Timeframe: From the date of the enrollment up to 24 months

evaluate the proportion of patients undergoing breast conservative surgery and/or sentinel node biopsy

Timeframe: up to 24 months

Trial details

NCT IDNCT07428018

SponsorMario Negri Institute for Pharmacological Research

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-04-30

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