Health TrialsbyHealthPanel

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

ConditionsBreast CancerHER2 + Breast CancerHR PositiveNeoadjuvant Therapy
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-90
SponsorMario Negri Institute for Pharmacological Research

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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,

Disqualifiers

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,

basal or squamous cell carcinoma of the skin,

Trial design

Design model

Parallel

Treatments tested in this trial

  • Abemaciclib

    Drug

    neoadjuvant endocrine therapy (NET) plus abemaciclib

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: chemotherapy (NCT)No intervention 0 interventions
Group B: NET plus abemaciclibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
From the date of the enrollment up to 24 months
2

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").

Time frame
up to 24 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mario Negri Institute for Pharmacological Research

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Collaborator

Humanitas Research Hospital IRCCS, Rozzano-Milan

Collaborator

IRCCS San Raffaele

Collaborator

IEO Foundation

Collaborator

Papa Giovanni XXIII Hospital

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: