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.
Brief Title
Extended Clinical Follow up and Biospecimen Collection for Patients Enrolled in TAILORx and RxPONDER: A Companion Protocol
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.
* 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.
Categories
Central Contacts
Central Contact Role
Contact
Central Contact Phone
212-659-6754
Central Contact Email
joseph.sparano@mssm.edu
Completion Date
Completion Date Type
Estimated
Conditions
BREAST CANCER
Eligibility Criteria
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:
* 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:
Inclusion Criteria
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
* 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
Gender
Female
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT06786585
Org Class
Network
Org Full Name
Eastern Cooperative Oncology Group
Org Study Id
EA1241
Overall Status
Not yet recruiting
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Extended Clinical Follow up and Biospecimen Collection for Patients Enrolled in TAILORx and RxPONDER: A Companion Protocol
Primary Outcomes
Outcome 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.
Outcome Measure
Patterns of clonal evolution
Outcome Time Frame
2 years
Outcome 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.
Outcome Measure
Prevalence of the integrative cluster (IntClust) and intrinsic (PAM50) subtypes
Outcome Time Frame
2 years
Outcome 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.
Outcome Measure
Molecular signatures of primary tumor specimens
Outcome Time Frame
2 years
Secondary Outcomes
Outcome Description
Evaluated using weighted Cox models
Outcome Time Frame
2 years
Outcome Measure
Immune composition
Outcome Description
Evaluated using weighted Cox models
Outcome Time Frame
2 years
Outcome Measure
TME and cell-cell interactions
Outcome Description
Evaluated using weighted Cox models
Outcome Time Frame
2 years
Outcome Measure
Prevalence of IntClust and PAM50
Outcome Description
Evaluated using weighted Cox models
Outcome Time Frame
2 years
Outcome Measure
Molecular signatures
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
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.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Della Makower
Investigator Email
DMAKOWER@montefiore.org
Investigator Sponsor Organization
External
Study Department
Oncology (Medical/Hematologic)
Study Division
Medical and Hematologic Oncology
Categories Mesh Debug
Breast Cancer --- BREAST NEOPLASMS
Cancer --- NEOPLASMS BY SITE
Cancer --- NEOPLASMS
MeSH Terms
BREAST NEOPLASMS
NEOPLASMS BY SITE
NEOPLASMS
BREAST DISEASES
SKIN DISEASES
SKIN AND CONNECTIVE TISSUE DISEASES