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Anatomic Stage I Breast Cancer AJCC v8NCT07136493

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

A study testing Biospecimen Collection, Electronic Health Record Review and Survey Administration in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by City of Hope Medical Center at 5 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Biospecimen Collection, Electronic Health Record Review and Survey Administration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
5 sitesUnited States
Study dates
12 May 2026to 16 Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 lymphoma or sarcoma are not allowed
  • Willingness to:
  • Provide blood samples
Show all 16Show fewer
  • Provide archival tumor tissue sample (only necessary for Cohort 2 if analysis of surgical tissue was not successful)
  • Provide tumor tissue sample from resection/surgery (only necessary for Cohort 1 if 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 B OR Cohort 2
  • COHORT 1: Must have archival diagnostic tissue available
  • COHORT 1: Scheduled to undergo, but has not yet begun, neoadjuvant systemic therapy followed 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 and PR ≤ 10% by immunohistochemistry (IHC) and HER2 negative, by current ASCO/CAP guidelines
  • COHORT 2: Scheduled to undergo upfront curative surgical resection with or without adjuvant chemotherapy followed by adjuvant endocrine therapy
  • COHORT 2: ER+/any PR/HER2- (ER positive defined as ER > 10% by IHC)

Who cannot join

  • 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 principal investigator (PI)/ a co-investigator/ the study manager
  • A direct study team member
  • Inability to give informed consent

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010

  • CTCA at Western Regional Medical Center

    Goodyear, Arizona, 85338

  • City of Hope at Irvine Lennar

    Irvine, California, 92618

  • City of Hope Atlanta Cancer Center

    Newnan, Georgia, 30265

  • City of Hope at Chicago

    Zion, Illinois, 60099

Other trials in United States

About this study

Official title: Evaluation of Circulating Tumor DNA Based Minimal Residual Disease Detection in Early Stage Breast Cancer Patients: A Prospective Study

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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:

  1. 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.

  1. 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:

  1. 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.

Being tested
Biospecimen Collection, Electronic Health Record Review, Survey Administration
Medical subject headings
Triple Negative Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood samples for ctDNA testing

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo possible collection of tissue

  • Electronic Health Record ReviewOther

    Ancillary studies

  • Survey AdministrationOther

    Ancillary studies

Study groups in NCT07136493
Study groupRoleWhat they receive
Cohort 1 (blood collection for ctDNA testing - 1)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Survey Administration
Cohort 2 (blood collection for ctDNA testing -2)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Other: Electronic Health Record Review; Other: Survey Administration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 3 years after standard of care (SOC) surgery

  2. 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.

    Measured: Before and after SOC surgery (up to 3 years)

Secondary outcomes (6)

  1. 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.

    Measured: Before and after adjuvant chemotherapy and/or radiation therapy (up to 3 years)

  2. 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.

    Measured: Up to 3 years post-definitive treatment

  3. 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.

    Measured: Post-neoadjuvant treatment and post-surgery (up to 3 years)

  4. 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.

    Measured: Up to 3 years after SOC surgery

  5. 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).

    Measured: Up to 3 years after SOC surgery

  6. 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.

    Measured: Up to 3 years after SOC surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2025
  2. Study start12 May 2026 (estimated)
  3. Primary completion16 Jun 2026
  4. Study completion16 Jun 2026

Why it stopped: Funding This study has been closed at City of Hope at the request of the Sponsor due to delays and changes in study timeline.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07136493
Sponsor's protocol ID
24463
Other IDs
NCI-2025-05431, 24463, P30CA033572
Status last verified
Jun 2026
First submitted
10 Aug 2025
Last updated
25 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Biospecimen Collection, Electronic Health Record Review and Survey Administration in people with Anatomic Stage I Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, run by City of Hope Medical Center at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 25 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients that achieve a pathologic complete response and are circulating tumor deoxyribonucleic acid (ctDNA) detectable (Cohort 1) (time frame: Up to 3 years after standard of care (SOC) surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07136493.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2026.

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