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Blood test may help tailor breast cancer treatment

NCT ID NCT05333874

Knowledge-focused Sponsor: Rutgers, The State University of New Jersey Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This pilot study is testing whether a personalized blood test that looks for leftover tumor DNA can help doctors make better treatment decisions for people with early-stage breast cancer. About 34 participants with triple-negative or HER2-positive breast cancer will receive chemotherapy before surgery, then have their blood tested after surgery. If the test finds cancer DNA, patients may choose to change their follow-up treatment. The goal is to see if this approach improves outcomes and reduces unnecessary treatments.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Neoadjuvant chemotherapy and a personalized blood test (Signatera) that detects tumor DNA in the blood
What this could lead to
If successful, this could help doctors decide whether more or less treatment is needed after surgery, potentially reducing unnecessary side effects.
What could go wrong
This is a very early pilot study with only 34 participants, so results may not apply to everyone. The blood test is still experimental and may not always be accurate.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 34 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2022

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Participants with a diagnosis of clinical Stage II-III triple negative and/or HER2 positive breast cancer * Age ≥ 18 years * Estimated life expectancy of at least twelve months * Participant must be eligible for neoadjuvant systemic therapy per treating physician * Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 * Able to provide signed and dated informed consent form * Must have ctDNA at the time of screening to be eligible for the study * Participants enrolled on other systemic therapy trials may be eligible to participate in the study after discussion with principal investigator * Be willing to present for medical exams and blood draws as scheduled per protocol Exclusion Criteria: * Evidence of metastatic breast cancer * Any other concurrent malignancy * Prior malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) unless a complete remission was achieved at least one year prior to study entry * Participant is pregnant * Serious concomitant systemic disorder that would compromise the safety of the participant or compromise the participant's ability to complete the study, at the discretion of the investigator * Bone marrow transplant or other organ transplant recipient * History of psychiatric illness or social situations that would limit compliance with study requirements * Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject's participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm HER2 positive breast carcinoma triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer, early-onset

Contacts and locations

Locations

  • Cooperman Barnabas Medical Center

    Livingston, New Jersey, 07052, United States

  • Jersey City Medical Center

    Jersey City, New Jersey, 07302, United States

  • Monmouth Medical Center

    Long Branch, New Jersey, 07740, United States

  • Monmouth Medical Center - Southern Campus

    Lakewood, New Jersey, 08701, United States

  • Monmouth Medical Center Vantage Point Infusion Cente

    West Long Branch, New Jersey, 07746, United States

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112, United States

  • RWJBarnabas Health - Robert Wood Johnson University Hospital

    Hamilton, New Jersey, 08690, United States

  • Robert Wood Johnson Barnabas Hospital -Somerset

    Somerville, New Jersey, 08876, United States

  • Robert Wood Johnson University Hospital

    New Brunswick, New Jersey, 08901, United States

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08903, United States

  • Steeplechase Cancer Center

    Somerville, New Jersey, 08876, United States

  • Trinitas Hospital and Comprehensive Cancer Center

    Elizabeth, New Jersey, 07202, United States

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