Clinical trial · Observational
Extended Clinical Follow up and Biospecimen Collection for Patients Enrolled in TAILORx and RxPONDER: A Companion Protocol
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (3)
- label
- Cohort 1
- description
- Previously enrolled on TAILORx with recurrence score (RS) 0-100 AND had a biopsy-confirmed locoregional, distant, or both locoregional and distant recurrence prior to registration on EA1241.
- label
- Cohort 2
- description
- Previously enrolled on Step 2 of RxPONDER with recurrence score (RS) 0-25 AND had a biopsy-confirmed locoregional, distant, or both locoregional and distant recurrence prior to registration on EA1241.
- label
- Cohort 3
- description
- Previously enrolled on Step 1 of RxPONDER and found to have a high Oncotype DX Recurrence Score (RS) 26-100.
Primary outcomes (3)
- measure
- Patterns of clonal evolution
- timeFrame
- 2 years
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient must have met the criteria for 1 of the 3 possible cohorts described below: 1. Cohort 1: Previously enrolled on TAILORx (PACCT-1) with recurrence score (RS) 0-100 AND had a biopsy-confirmed locoregional, distant, or both locoregional and distant recurrence prior to registration on this protocol. 2. Cohort 2: Previously enrolled on Step 2 of RxPONDER (S1007) with a recurrence score (RS) of 0-25 AND had a biopsy-confirmed locoregional, distant, or both locoregional and distant recurrence prior to registration on this protocol. 3. Cohort 3: Previously enrolled on Step 1 of RxPONDER and found to have a high Oncotype DX RS 26-100. * Patient must have been a TAILORx (RS 0-100) or RxPONDER (RS 0-100) study participant who has the ability to understand and the willingness to sign a written informed consent document for participation in this non-intervention study (cohorts 1, 2, or 3). Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible. * Patient must have tumor tissue available from each cohort as outlined below: * Patients from Cohorts 1 and 2 must have relapse tumor tissue specimen available at the time of registration for submission to ECOG-ACRIN Central Biorepository and Pathology Facility within 30 days of registration. * Patients from Cohort 3 must have primary tumor tissue specimen available at time of EA1241 registration for submission to ECOG-ACRIN Central Biorepository and Pathology Facility within 30 days of registration Exclusion Criteria:
References
Publications (0)
Data not yet available