NCT07428018

Brief 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

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2 breast-cancer

Timeline
35mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Apr 2029

First Submitted

Initial submission to the registry

February 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2029

Last Updated

March 5, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

February 17, 2026

Last Update Submit

March 3, 2026

Conditions

Breast CancerHER2 + Breast CancerHR PositiveNeoadjuvant Therapy

Keywords

breastoncotype dxabemaciclibneoadjuvant treatmentsurgical deescalation

Outcome Measures

Primary Outcomes (2)

  • 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

    the proportion of patients with ER+/HER2- EBC who avoid (neo)adjuvant chemotherapy according to the MDT decision based on the ODX RS assessment in the tumor biopsy specimen and the availability of abemaciclib/ET option for the lower RS group

    From the date of the enrollment up to 24 months

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

    the proportion of patients who de-escalate surgery after neoadjuvant therapy comparing the baseline surgical indication of the MDT to the effective surgery (at least one of: "from mastectomy to breast conservative surgery" OR "from lymph node dissection to sentinel node biopsy").

    up to 24 months

Study Arms (2)

chemotherapy (NCT)

NO INTERVENTION

Neoadjuvant chemotherapy (NCT), including sequential standard regimens with sequential anthracyclines and taxanes,

NET plus abemaciclib

EXPERIMENTAL

neoadjuvant endocrine therapy (NET) plus abemaciclib.

Drug: Abemaciclib

Interventions

AbemaciclibDRUG

neoadjuvant endocrine therapy (NET) plus abemaciclib

NET plus abemaciclib

Eligibility Criteria

Age18 Years - 90 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • female aged 18 years or older
  • primary, histologically confirmed diagnosis of invasive breast carcinoma,
  • estrogen receptor (ER)-positive tumor, defined as ≥10% by immunohistochemistry and measured as per ASCO/CAP guidelines (Allison et al.2020). Any progesterone receptor expression is acceptable (as per local assessment)
  • documented human epidermal growth factor receptor-2 (HER2)-negative tumor as per ASCO/CAP guidelines, assessed locally,
  • stage II-IIIB as per AJCC TNM classification (8th edition). Absence of distant metastases (with the exception of tumor detected in internal mammary chain nodes by sentinel node procedure),
  • candidate to receive neoadjuvant chemotherapy according to the indication of a multidisciplinary tumor board,
  • not eligible to receive upfront breast conservative surgery (but considered potentially eligible to receive a BCS in case of tumor downstaging) AND/OR not candidate to sentinel lymph node dissection because of clinical node positive disease
  • Eastern Cooperative Oncology Group Performance Status 0-1,
  • The patient is able to swallow oral medications
  • normal hematologic parameters:
  • a.) absolute neutrophil count ≥ ≥1500/mm3 (1.5 × 10 9/L), b) platelets ≥ 100 × 10 9/L, c)hemoglobin ≥ 8 g/dL (≥ 80 g/L)). Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin earlier than the day after the erythrocyte transfusion
  • normal renal function: serum creatinine concentration ≤1.5 ULN or calculated clearance ≥50 mL/min according to the Cockcroft-Gault formula,
  • normal liver function:
  • a.)serum total bilirubin ≤ 1.5 × upper limit of normal (ULN). Patients with Gilbert's syndrome with a total bilirubin ≤2.0 times ULN and direct bilirubin within normal limits are permitted., b)AST and ALT ≤ 3 × ULN, c)alkaline phosphatase ≤ 2.5 × ULN,
  • women of child bearing potential must have documented negative pregnancy test within 2 weeks (preferably 7 days) prior to study entry and must agree to effective non-hormonal contraception (barrier method - condoms, diaphragm -also in conjunction with spermicidal jelly, or total abstinence) after the pregnancy test and up to surgery. Oral, injectable, or implant hormonal contraceptives or medicated IUD are not allowed during the trial,
  • +1 more criteria

You may not qualify if:

  • presence of distant metastases (stage IV) or stage IIIC disease,
  • inflammatory or locally-advanced, inoperable breast cancer
  • previous invasive ipsilateral breast cancer at any time,
  • previous or concomitant invasive malignancy. The exceptions are patients with the following (and only the following) malignancies (previous or concomitant), if adequately treated:
  • 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,
  • borderline or stage I ovarian cancer
  • known history of uncontrolled or symptomatic angina, uncontrolled hypertension (≥ 180/110 mmHg), uncontrolled diabetes mellitus, dyspnea at rest, chronic therapy with oxygen, a New York Heart Association (NYHA) class III or IV congestive heart failure, syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin (including, but not limited to, ventricular tachycardia and ventricular fibrillation), or sudden cardiac arrest
  • females who are pregnant or lactating (lactation has to stop before study entry)
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Milan, MI, 20156, Italy

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

abemaciclib

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: phase II, pragmatic
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 17, 2026

First Posted

February 23, 2026

Study Start

April 30, 2026

Primary Completion (Estimated)

April 30, 2029

Study Completion (Estimated)

April 30, 2029

Last Updated

March 5, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)