Clinical trial NCT06762977: A Composite Assay for HER2-positive Early-stage Breast Cancer Management
Official title: A Composite Assay for HER2-positive Early-stage Breast Cancer Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Early Stage Breast Cancer (Stage 1-3)
HER2
Keywords: HER2-positive
operable breast cancer
gene-expression based classifier
prognosis
Lead sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Sponsor class: OTHER
Collaborators: name: Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
name: Ospedale Di Summa-Perrino
First posted: 2025-01-08
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Clinical information and paraffin-embedded tumor tissue samples from HER2-positive operable breast cancer patients included in the study were prospectively and consecutively collected at the participating centers and are now being analyzed for the purpose of the protocol.

Brief summary: The goal of this observational study is to assess the prognostic value of a genomic classifier (S18) and its refined version (S\*) in women with early-stage HER2-positive breast cancer. The study aims to determine whether these tools can predict event-free (EFS) and disease-free survival (DFS) in patients treated with neoadjuvant and/or adjuvant trastuzumab-based therapies.

Detailed description: The population includes women aged 18 or older with stage I-III HER2-positive breast cancer who received trastuzumab ± pertuzumab. Data and tumor tissue samples from this population have been collected prospectively from Istituto Nazionale dei Tumori IRCCS Fondazione Pascale, Naples (cohort A), and from Ospedale "Di Summa-Perrino", Brindisi (cohort B). The study integrates clinical-pathological and genomic data to refine and validate the prognostic capabilities of the S18 classifier.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 18 years
2. Operable breast cancer (stage I-III)
3. Any status of hormone receptor in the primary tumor, according to institutional guidelines
4. HER2-positive primary tumor, according to ASCO guidelines, i.e., HER2-positive phenotype by immunohistochemistry (IHC) 3+ or 2+ with a positive result for ERBB2 gene amplification analysis using ISH techniques (CISH, SISH, FISH)
5. Neoadjuvant and/or adjuvant therapy based on trastuzumab ± pertuzumab
6. Written informed consent from patients

Exclusion Criteria:

1. Patient in follow-up for less than 3 years after surgery
2. A prior diagnosis of invasive cancer before the diagnosis of breast cancer

Primary outcomes:
measure: Event-free survival (EFS) and Disease-free survival (DFS) according to the value of S18 and S*
timeFrame: From the initiation of systemic therapy through to at least 3 years post-treatment.
Secondary outcomes:
measure: Explorative evaluation of overall survival (OS) according to the value of S18 and S*
timeFrame: From the initiation of therapy through to at least 3 years post-treatment.
measure: Evaluation of pathological complete response (pCR) according to the value of S18 and S*
timeFrame: Assessed in the surgical specimen obtained from definitive surgery performed within up to 10 months of initiating neoadjuvant treatment.
Other outcomes:
Locations:
city: Brindisi
country: Italy
facility: Ospedale Di Summa-Perrino
city: Naples
country: Italy
facility: Istituto Nazionale Tumori IRCCS - Fondazione G. Pascale
Study officials:
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
name: Serena Di Cosimo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
name: Paolo Verderio, PhD
role: STUDY_CHAIR
References: