NCT06894173 EvoLution of Neoadjuvant TreatMent in 'Triple-negative' or 'HER-2-positive' Breast Cancer Diagnosed in the EaRly Phase
| NCT ID | NCT06894173 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2022-12-03 |
| Primary Completion | 2025-12-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2022-12-03 with a primary completion date of 2025-12-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Alessandra Fabi
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Senologia
Frequently Asked Questions
Who can join the NCT06894173 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06894173 currently recruiting?
Yes, NCT06894173 is actively recruiting participants. Contact the research team at alessandra.fabi@policlinicogemelli.it for enrollment information.
Where is the NCT06894173 trial being conducted?
This trial is being conducted at Aviano, Italy, Ancona, Italy, Avellino, Italy, Brindisi, Italy and 11 additional locations.
Who is sponsoring the NCT06894173 clinical trial?
NCT06894173 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Alessandra Fabi at Fondazione Policlinico Universitario A.Gemelli IRCCS, UOC Senologia. The trial plans to enroll 1,000 participants.
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