An interventional study of Biospecimen Collection and Biospecimen Collection in Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8 and Anatomic Stage III Breast Cancer AJCC v8, sponsored by City of Hope Medical Center. Withdrawn at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-25.
Sponsored by City of Hope Medical Center · Not applicable, Interventional, and Screening
This clinical trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) based minimal residual disease (MRD) detection works for patients with early-stage breast cancer. MRD refers to a very small number of tumor cells that remain in the body during or after treatment. ctDNA refers to small pieces of DNA that are released into a person's blood by tumor cells as they die. Management of patients after cancer surgery remains a clinical dilemma, particularly for cancer detected at earlier stages as many patients are cured by surgery alone. This results in very large clinical trials required to demonstrate a modest benefit from treatment. Using ctDNA MRD testing in early-stage breast cancer patients receiving standard treatment may help researchers identify groups that would benefit from additional therapy, leading to better outcomes.
PRIMARY OBJECTIVES:
I. To determine the pathologic response rate and presence of ctDNA post-neoadjuvant therapy in stage I-III breast cancer patients receiving neoadjuvant systemic therapy followed by curative-intent surgical resection, separately for Subgroup 1A: human epidermal growth factor receptor 2 positive (HER2+) (any estrogen receptor [ER]/progesterone receptor [PR] status) and Subgroup 1B: triple negative breast cancer (TNBC). (Cohort 1) II. To determine ctDNA detectability before and after curative-intent surgical resection in Cohort 2 ER+/any progesterone receptor (PR)/HER2- stage I-III breast cancer patients. (Cohort 2)
SECONDARY OBJECTIVES:
I. To determine ctDNA detectability before and after adjuvant chemotherapy and/or radiation therapy, by cohort and subgroup.
II. To determine ctDNA detectability during the follow-up period of up to 3 years after definitive treatment, by cohort and subgroup.
III. To describe, by cohort and subgroup, the association between detectable ctDNA measured post-neoadjuvant treatment and post-surgery with recurrence free survival (RFS).
IV. To describe, by cohort and subgroup, ctDNA levels at baseline and during neoadjuvant treatment and their association with clinical and pathologic response.
V. To describe, by cohort and subgroup, changes in ctDNA levels during systemic treatment (neoadjuvant and adjuvant) and association with clinical response determined radiographically.
VI. To describe, by cohort and subgroup, the difference in time between ctDNA detection (molecular recurrence) and radiographic evidence of disease recurrence following definitive treatment among patients who achieved undetectable ctDNA levels after surgery.
EXPLORATORY OBJECTIVE:
I. To explore the performance of up to two cancer detection assays - BestSEEK and enACT - in development by Dr. Tomasetti at TGen and City of Hope.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
COHORT 1: Patients undergo collection of blood samples for ctDNA testing at 14-21 days post cycle 1, day 1 of standard of care (SOC) neoadjuvant chemotherapy, on the day of SOC surgery, at 3-6 weeks after SOC surgery, at 1-2 weeks after SOC adjuvant radiation therapy (if receiving), at 2-4 weeks after SOC adjuvant systemic therapy (if receiving), every 3 months for 1 year after surgery, and then every 6 months up to year 3 after surgery. Patients may also undergo collection of tumor tissue during SOC surgery on study.
COHORT 2: Patients undergo collection of blood samples for ctDNA testing on the day of SOC surgery, at 3-6 weeks after SOC surgery, at 1-2 weeks after SOC adjuvant radiation therapy (if receiving), at 2-4 weeks after SOC adjuvant systemic therapy (if receiving), every 3 months for 1 year after surgery, and then every 6 months up to year 3 after surgery. Patients may also undergo collection of tumor tissue during SOC surgery on study.
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Willingness to:
Exclusion Criteria:
Patients undergo collection of blood samples for ctDNA testing at 14-21 days post cycle 1, day 1 of SOC neoadjuvant chemotherapy, on the day of SOC surgery, at 3-6 weeks after SOC surgery, at 1-2 weeks after SOC adjuvant radiation therapy (if receiving), at 2-4 weeks after SOC adjuvant systemic therapy (if receiving), every 3 months for 1 year after surgery, and then every 6 months up to year 3 after surgery. Patients may also undergo collection of tumor tissue during SOC surgery on study.
Procedure: Biospecimen Collection · Other: Electronic Health Record Review · Other: Survey Administration
Patients undergo collection of blood samples for ctDNA testing on the day of SOC surgery, at 3-6 weeks after SOC surgery, at 1-2 weeks after SOC adjuvant radiation therapy (if receiving), at 2-4 weeks after SOC adjuvant systemic therapy (if receiving), every 3 months for 1 year after surgery, and then every 6 months up to year 3 after surgery. Patients may also undergo collection of tumor tissue during SOC surgery on study.
Procedure: Biospecimen Collection · Other: Electronic Health Record Review · Other: Survey Administration
Undergo collection of blood samples for ctDNA testing
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Undergo possible collection of tissue
Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection
Ancillary studies
Ancillary studies
Proportion of patients that achieve a pathologic complete response and are circulating tumor deoxyribonucleic acid (ctDNA) detectable (Cohort 1)
Baseline characteristics will be compared using the K-sample equality-of-medians test with continuity correction and the two-sample test of proportions. Cox proportional-hazards models, with the exact partial likelihood method to handle tied event times and adjusting for post-baseline ctDNA (negative versus positive), baseline tumor marker (not elevated versus elevated), and tumor stage as pre-specified confounders. Other confounders will be adjusted for as appropriate.
Time frame: Up to 3 years after standard of care (SOC) surgery
ctDNA detection rate (Cohort 2)
Baseline characteristics will be compared using the K-sample equality-of-medians test with continuity correction and the two-sample test of proportions. Cox proportional-hazards models, with the exact partial likelihood method to handle tied event times and adjusting for post-baseline ctDNA (negative versus positive), baseline tumor marker (not elevated versus elevated), and tumor stage as pre-specified confounders. Other confounders will be adjusted for as appropriate.
Time frame: Before and after SOC surgery (up to 3 years)
ctDNA detection rate 1
Baseline characteristics will be compared using the K-sample equality-of-medians test with continuity correction and the two-sample test of proportions. Cox proportional-hazards models, with the exact partial likelihood method to handle tied event times and adjusting for post-baseline ctDNA (negative versus positive), baseline tumor marker (not elevated versus elevated), and tumor stage as pre-specified confounders. Other confounders will be adjusted for as appropriate.
Time frame: Before and after adjuvant chemotherapy and/or radiation therapy (up to 3 years)
ctDNA detection rate 2
Baseline characteristics will be compared using the K-sample equality-of-medians test with continuity correction and the two-sample test of proportions. Cox proportional-hazards models, with the exact partial likelihood method to handle tied event times and adjusting for post-baseline ctDNA (negative versus positive), baseline tumor marker (not elevated versus elevated), and tumor stage as pre-specified confounders. Other confounders will be adjusted for as appropriate.
Time frame: Up to 3 years post-definitive treatment
Recurrence free survival (RFS)
Baseline characteristics will be compared using the K-sample equality-of-medians test with continuity correction and the two-sample test of proportions. RFS will be compared using univariate and multivariate Cox proportional-hazards models, with the exact partial likelihood method to handle tied event times and adjusting for post-baseline ctDNA (negative versus positive), baseline tumor marker (not elevated versus elevated), and tumor stage as pre-specified confounders.
Time frame: Post-neoadjuvant treatment and post-surgery (up to 3 years)
ctDNA level
Baseline characteristics will be compared using the K-sample equality-of-medians test with continuity correction and the two-sample test of proportions. Cox proportional-hazards models, with the exact partial likelihood method to handle tied event times and adjusting for post-baseline ctDNA (negative versus positive), baseline tumor marker (not elevated versus elevated), and tumor stage as pre-specified confounders. Other confounders will be adjusted for as appropriate.
Time frame: Up to 3 years after SOC surgery
Rate of concordance between ctDNA changes on systemic treatment and clinical response
Agreement in change in ctDNA and radiologic response will be assessed based on increase/decrease/clearance in ctDNA and response of complete response/partial response/stable disease or progressive disease. Data visualization may be used to help understand changes in ctDNA over time by patient, cohort, subgroup, and treatment type (e.g., a spider plot).
Time frame: Up to 3 years after SOC surgery
Difference in time between ctDNA detection date and radiographic disease progression date
In patients with undetectable ctDNA levels directly following surgery, the time when ctDNA is first detected during follow-up will be identified and the proximity of this time to radiographic evidence of disease will be calculated. Kaplan-Meier will be used to estimate the median time interval for detection of disease, as we anticipate censoring to occur with this endpoint.
Time frame: Up to 3 years after SOC surgery
This study is withdrawn, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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