Transcripts with Retained H/ACA Box SnoRNA Sequences As Biomarkers for Estrogen Dependence in Lum-B Breast Carcinomas

NCT06805084 | Active Not Recruiting

• 2 other identifiers: H/ACA-ERRC-2024-2790680
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: The primary treatment for estrogen receptor-positive breast cancer relies on estrogen receptor inhibitors. However, responses to hormonal therapy can vary significantly, especially in luminal B breast cancer, necessitating adjuvant chemotherapy for some patients. The Oncotype DX Breast Recurrence Score is the preferred test for determining the most suitable therapy for these patients, providing a Recurrence Score that characterizes the tumor and guides treatment recommendations. Despite its validation, its optimal use in intermediate-risk patients is still unclear. OBJECTIVES: Primary Objective: \- Measure whether the expression of mRNAs extracted from paraffin-embedded tissue is associated with the results of the Oncotype DX test. The primary objective is to evaluate the association between selected mRNA expressions from paraffin-embedded luminal B breast cancer tissue and Oncotype DX test results. This aims to improve current molecular clinical tests and identify new biomarkers for response to anti-estrogen therapy, particularly in luminal B patients with inadequate responses. Secondary Objectives:

• Assess concordance of mRNA analysis results from paraffin-embedded versus "fresh frozen" tissue.
• Evaluate if mRNA expression levels from paraffin-embedded tissue provide additional characterization for low-risk luminal B patients who do not respond effectively to anti-estrogen therapy. ENDPOINTS: Primary Endpoint: Measure potential mRNA biomarker expression values in therapy response groups identified by the Oncotype DX score (low-risk and high-risk). Secondary Endpoints:
• Measure abundance values of potential mRNA biomarkers from both analysis techniques.
• Calculate treatment response parameters at 36-60 months (Relapse-Free Survival - RFS, Distant Recurrence-Free Survival - DRFS). STUDY DESIGN: This study will analyze specific mRNAs in luminal B breast cancer patients by collecting and examining both "fresh frozen" and paraffin-embedded tumor tissues. qPCR will evaluate mRNA expressions of WIPI1, STAT5B, SMAP2, MED24, NCOA3, NCOA7, CCAR1, along with isoforms of EIF4A1, EIF4A2, TAF1D, and UBAP2L. Results will be correlated with Oncotype DX outcomes and diagnostic parameters regarding treatment response. Samples will be collected per standard procedures, ensuring patient treatment aligns with clinical practices, with follow-up data monitored accordingly.

Conditions

Breast Adenocarcinoma; Luminal B Breast Cancer

Keywords

oncotype; biomarkers; non coding RNAs

Outcome Measures

Primary Outcomes (1)

• Measure whether the expression of mRNAs extracted from paraffin-embedded tissue is associated with the results of the Oncotype DX test.

  The primary objective is to evaluate whether the expression of selected mRNAs extracted from paraffin-embedded luminal B breast cancer tissue is associated with the results of the Oncotype DX test. This comparison aims to refine and improve current molecular clinical tests by assessing their potential as new biomarkers in defining the response to anti-estrogen therapy. This research seeks to identify expression patterns of these RNAs in luminal B patients who exhibit an inadequate response to anti-cancer treatments targeting estrogen receptors.

  3 years

Secondary Outcomes (2)

• concordance between fresh and archival material

  1 year

• association with treatment response

  7 years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be adult female patients with breast cancer who have not previously undergone neoadjuvant chemotherapy and/or hormone therapy and are candidates for surgical removal of breast cancer as part of their standard care pathway. Participants will be selected/enrolled if tissue samples are available or will be obtained within the period between 2019 and 2026. The unit responsible for enrollment will be the Oncology Department - Zamagni IRCCS, Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola. Patients will be contacted during a follow-up visit or, if not possible, through an invitation sent by email.

You may qualify if:

• Patients with luminal B breast cancer who have undergone the Oncotype DX test at our pathology center, with tissue material available or expected to become available during the enrollment period.
• Age ≥ 18 years
• Informed consent

You may not qualify if:

• none

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero Unversitaria di Bologna

Bologna, BO, 4018, Italy

Location

Biospecimen

Retention: SAMPLES WITH DNA

frozen and formalin fixed tumor specimen

Study Officials

• Lorenzo Montanaro, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2025
• First Posted: February 3, 2025
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2031
• Last Updated: February 3, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)