Circulating Tumor DNA Based Minimal Residual Disease Detection for Patients With Early-Stage Breast Cancer

Last updated: March 3, 2026
Sponsor: City of Hope Medical Center
Overall Status: Suspended

Phase

N/A

Condition

Metastatic Triple-negative Breast Cancer

Carcinoma

Treatment

Biospecimen Collection

Electronic Health Record Review

Survey Administration

Clinical Study ID

NCT07136493
24463
24463
NCI-2025-05431
P30CA033572
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented written informed consent of the participant

  • Age ≥ 18 years

  • Diagnosis of stage I-III breast cancer (any gender)

  • Malignancy must be epithelial. Non-epithelial breast malignancies such as lymphomaor sarcoma are not allowed

  • Willingness to:

  • Provide blood samples

  • Provide archival tumor tissue sample (only necessary for Cohort 2 if analysisof surgical tissue was not successful)

  • Provide tumor tissue sample from resection/surgery (only necessary for Cohort 1if analysis of surgical tissue was not successful)

  • Permit medical record review

  • Fall into one of the following categories defined below: Cohort 1, Subgroup A or BOR Cohort 2

  • COHORT 1: Must have archival diagnostic tissue available

  • COHORT 1: Scheduled to undergo, but has not yet begun, neoadjuvant systemic therapyfollowed by curative resection

  • COHORT 1 (Subgroup A): HER2+ by current American Society of Clinical Oncology (ASCO)/College of American Pathologist (CAP) guidelines (any ER/PR status)

  • COHORT 1 (Subgroup B): Triple negative (ER, PR and HER2 negative). Defined as ER andPR ≤ 10% by immunohistochemistry (IHC) and HER2 negative, by current ASCO/CAPguidelines

  • COHORT 2: Scheduled to undergo upfront curative surgical resection with or withoutadjuvant chemotherapy followed by adjuvant endocrine therapy

  • COHORT 2: ER+/any PR/HER2- (ER positive defined as ER > 10% by IHC)

Exclusion

Exclusion Criteria:

  • Ductal carcinoma in situ

  • Inability to safely provide sequential blood samples

  • Prior or concurrent invasive malignancy (unless disease free > 5 years)

  • An employee who is under the direct/ indirect supervision of the principalinvestigator (PI)/ a co-investigator/ the study manager

  • A direct study team member

  • Inability to give informed consent

Study Design

Total Participants: 350
Treatment Group(s): 3
Primary Treatment: Biospecimen Collection
Phase:
Study Start date:
May 12, 2026
Estimated Completion Date:
March 30, 2028

Study Description

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.

Connect with a study center

  • CTCA at Western Regional Medical Center

    Goodyear, Arizona 85338
    United States

    Site Not Available

  • CTCA at Western Regional Medical Center

    Goodyear 5296266, Arizona 5551752 85338
    United States

    Site Not Available

  • City of Hope Comprehensive Cancer Center

    Duarte, California 91010
    United States

    Site Not Available

  • City of Hope at Irvine Lennar

    Irvine, California 92618
    United States

    Site Not Available

  • City of Hope Comprehensive Cancer Center

    Duarte 5344147, California 5332921 91010
    United States

    Site Not Available

  • City of Hope at Irvine Lennar

    Irvine 5359777, California 5332921 92618
    United States

    Site Not Available

  • City of Hope Atlanta Cancer Center

    Newnan, Georgia 30265
    United States

    Site Not Available

  • City of Hope Atlanta Cancer Center

    Newnan 4212684, Georgia 4197000 30265
    United States

    Site Not Available

  • City of Hope at Chicago

    Zion, Illinois 60099
    United States

    Site Not Available

  • City of Hope at Chicago

    Zion 4917358, Illinois 4896861 60099
    United States

    Site Not Available

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