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NCT Number: NCT06894173

EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase

The primary objective of this study is to describe the percentage of patients with HER2-positive and Triple Negative tumour underwent neoadjuvant treatment in clinical practice during the past 5 years out of total number of patients who underwent neoadjuvant treatment, regardless molecular subtypes. Secondary objectives The secondary objectives which are limited to molecular subtypes of study interest, HER2-positive and Triple Negative tumours, are follow reported:

* To perform a descriptive analysis on neoadjuvant treatment choice according to molecular subtype and initial staging; * To perform a descriptive analysis on clinical and tumour pathological characteristics according to molecular subtypes and initial staging; * To perform radiological response descriptive analysis achieved with neoadjuvant therapy according to treatment and instrumental examination type (for example: breast MRI, breast ultrasound or mammography); * To perform a descriptive analysis of surgical procedures for both, the breast and the axilla, according to radiological tumour response, initial staging and molecular subtypes; * To perform a descriptive analysis on therapies performed in adjuvant setting according to neoadjuvant treatment type, initial staging and molecular subtypes; * To describe and to analyse the eligibility criteria evolution in neoadjuvant treatment setting during the last 5 years; * To perform a descriptive analysis on pathological complete response (cPR) according to neoadjuvant treatment, molecular subtypes and initial staging; * To evaluate disease-free survival (DFS) according to pCR and molecular subtypes; * To evaluate overall survival (OS) according to pCR and molecular subtypes.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS - Centro di Riferimento Oncologico (C.R.O.) di Aviano, Aviano, PN, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • For primary endpoint assessment we calculated the percentage of HER2 positive and Triple Negative patients who underwent neoadjuvant treatment in the past 5 years in each site. For this aim all patients with early breast cancer diagnosis who underwent neoadjuvant treatment during the study time, ranging from 01/01/2016 to 01/01/2021, will be included if they had:
  • Histological diagnosis of infiltrating breast cancer performed by breast and/or axillary nodes biopsy;
  • Age ≥ 18 years at the time of disease onset;
  • Absence of secondary lesions, i.e. initial disease stage I, II or III;
  • Known status of ER, PgR, HER-2 and Ki67.

Exclusion criteria

  • Documented distant disease at onset diagnosis or within 3 months from breast surgery;
  • Prior neoadjuvant hormonal treatment exposure;
  • Prior diagnosis of primary breast cancer or second primitive tumour starting from different organ

Treatment and study plan

Primary outcomes

  1. Percentage of patients with HER2-positive and Triple Negative tumour among early breast cancer who underwent neoadjuvant treatment

    Time frame: 5 years

    The primary endpoint will express as the ratio between the total number of patients with HER2-positive and TN tumour who underwent neoadjuvant treatment out of total number of patients who had early breast cancer diagnosis and who underwent neoadjuvant treatment during the entire study time, regardless molecular subtype. The primary endpoint will be calculated according molecular subtypes, as follow specified: 'Luminal a and b', 'Triple Negative', 'HER-2 enriched' and 'HER-2 luminal'. The molecular subtypes will be identified and classified according to the 2018 American Society of Clinical Oncology and College of American Pathologists (ASCO-CAP) definition.

Secondary outcomes

  1. The frequency of different treatments used in neoadjuvant setting according to initial staging and molecular subtypes;

    Time frame: 5 years

    HER-2 positive and Triple Negative patients subtypes.

  2. The frequency of different clinical and pathological tumour characteristics according to initial staging and molecular subtypes;

    Time frame: 5 years

    HER-2 positive and Triple Negative patients

  3. The frequency of complete radiological response according to neoadjuvant treatment, instrumental examination (breast MRI, breast ultrasound or mammography) used in clinical practice and molecular subtypes;

    Time frame: 5 years

    HER-2 positive and Triple Negative patients

  4. The frequency of different surgical procedures for both, the breast and the axilla, according to radiological response, initial staging and molecular subtypes;

    Time frame: 5 years

    HER-2 positive and Triple Negative patients

  5. The frequency of different treatments adopted in adjuvant setting according to neoadjuvant treatment type, initial staging and molecular subtypes.

    Time frame: 5 years

    HER-2 positive and Triple Negative patients

  6. The frequency of pathologic complete response (pCR) according to molecular subtypes and neoadjuvant treatment;

    Time frame: 5 years

    HER-2 positive and Triple Negative patients

  7. Descriptive analysis of the correlation between complete radiologic response and pCR according to molecular subtypes and neoadjuvant treatment.

    Time frame: 5 years

    HER-2 positive and Triple Negative patients

  8. Descriptive analysis of the correlation between pCR and DFS according to the different molecular subtypes.

    Time frame: 5 years

    HER-2 positive and Triple Negative patients. DFS will be calculated as time interval from the date of first neoadjuvant cycle to the date of onset disease recurrence at local, contralateral or at distance level. For patients without recurrence at the time of DFS analysis, the second date will be censored at the time of last control.

  9. Correlation analysis between pCR and OS according to the different molecular subtypes.

    Time frame: 5 years

    HER-2 positive and Triple Negative patients.

Study contacts

Contact information is provided by the study sponsor or research team.

Alessandra Fabi, MD

CONTACT

[email protected]

0630157337

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase: Retrospective Multicentre Study on the Therapeutic Approach Most Commonly Adopted in the Italian Oncology Centres

Acronym: GIM28-ELMER

Important dates

Study start
2022
Primary completion
2025
Study completion
2026
First posted
Mar 25, 2025
Registry last updated
Mar 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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