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

NCT06786585 | Not Yet Recruiting

• 1 other identifier: EA1241
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  2 years

Secondary Outcomes (4)

• Immune composition

  2 years

• TME and cell-cell interactions

  2 years

• Prevalence of IntClust and PAM50

  2 years

• Molecular signatures

  2 years

Study Arms (3)

Cohort 1

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.

Cohort 2

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.

Cohort 3

Previously enrolled on Step 1 of RxPONDER and found to have a high Oncotype DX Recurrence Score (RS) 26-100.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients previously enrolled on TAILORx with a recurrence score (RS) 0-100\_and RxPONDER with a recurrence score(RS) 0-25 and patients previously enrolled on RxPONDER with a recurrence score (RS) 26-100.

You may qualify if:

• Patient must have met the criteria for 1 of the 3 possible cohorts described below:
• 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.
• 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.
• 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

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• United States Department of Defense: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Submission of relapse tumor tissue specimen from biopsy confirmed cancer recurrence from patients in cohorts 1 and 2. Submission of primary tumor tissue specimen (and relapse tumor tissue if applicable from patients in cohort 3.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Joseph A Sparano, MD

  Eastern Cooperative Oncology Group

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joseph A Sparano, MD

CONTACT

212-659-6754; joseph.sparano@mssm.edu

Study Design

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

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 22, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: May 30, 2025

Record last verified: 2025-05