NCT06786585

Extended Clinical Follow up and Biospecimen Collection for Patients Enrolled in TAILORx and RxPONDER: A Companion Protocol

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Eastern Cooperative Oncology Group · Network
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to retrieve tissue samples from individuals with breast cancer who previously enrolled on the PACCT-1 (TAILORx) or S1007 (RxPONDER) trials and experiences a recurrence of their cancer (Cohort 1, 2, and 3), and/or the tumor initially removed at surgery in patients previously enrolled in step 1 of S1007 (RxPONDER) and found to have a high Recurrence Score of 26-100 (Cohort 3) but not followed on the study after that point. The tissue will be used for future research designed to understand why breast cancer recurs despite hormonal therapy or chemotherapy plus hormonal therapy.

Detailed description

To collect tumor biospecimens from patients who previously enrolled in either TAILORx or RxPONDER. There are 3 separate cohorts separated by recurrence score and study: * Cohort 1= TAILORx w/ recurrence score of 0-100 * Cohort 2= RXPONDER w/ recurrence score of 0-25 * Cohort 3= RxPONDER w/ recurrence score of 26-100 These samples will be used to assess the following primary objectives: * Patterns of clonal evolution and the landscape of somatic alterations in paired primary tumor samples and recurrence samples * Prevalence of the integrative cluster (IntClust) and intrinsic (PAM50) subtypes and of subtype switching in paired primary tumor samples and recurrence samples * Identify molecular signatures, including the SET 2/3 RNA expression assay, of primary tumor specimens associated with recurrence in patients with high genomic risk and high clinical risk (Cohort 3) who received adjuvant chemotherapy plus endocrine therapy. The study team also plans to evaluate immune composition and the prevalence of tumor-immune microenvironment (TME subtypes), and characterize the TME and cell-cell interactions in native tissue context through spatial tanscriptomic and proteomic profiling of tissue sections.

Conditions

• Breast Cancer

Timeline

• Start date: 2025-06-01
• Primary completion: 2027-04-01
• Completion: 2028-04-01
• First posted: 2025-01-22
• Last updated: 2025-05-30