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.
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.
Study Type
OBSERVATIONAL
Enrollment
600
Patterns of clonal evolution
Conditional logistic regression for matched pairs, with the recurrence sample representing the case and the baseline sample the non-case in each pair, will be used to test for differences between recurrence and baseline, to estimate odds ratios, and to jointly model effects. The test for association of a single binary factor in this approach is equivalent to McNemar's test.
Time frame: 2 years
Prevalence of the integrative cluster (IntClust) and intrinsic (PAM50) subtypes
Conditional logistic regression for matched pairs, with the recurrence sample representing the case and the baseline sample the non-case in each pair, will be used to test for differences between recurrence and baseline, to estimate odds ratios, and to jointly model effects. The test for association of a single binary factor in this approach is equivalent to McNemar's test.
Time frame: 2 years
Molecular signatures of primary tumor specimens
Conditional logistic regression for matched pairs, with the recurrence sample representing the case and the baseline sample the non-case in each pair, will be used to test for differences between recurrence and baseline, to estimate odds ratios, and to jointly model effects. The test for association of a single binary factor in this approach is equivalent to McNemar's test.
Time frame: 2 years
Immune composition
Evaluated using weighted Cox models
Time frame: 2 years
TME and cell-cell interactions
Evaluated using weighted Cox models
Time frame: 2 years
Prevalence of IntClust and PAM50
Evaluated using weighted Cox models
Time frame: 2 years
Molecular signatures
Evaluated using weighted Cox models
Time frame: 2 years
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