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Blood test may predict breast cancer return after chemo

NCT ID NCT06401421

Knowledge-focused Sponsor: Exact Sciences Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study is testing a new blood test that looks for tiny bits of tumor DNA to see if it can predict whether high-risk early breast cancer will come back after chemotherapy. About 1,800 people with early-stage breast cancer who are about to start chemo will give blood and tissue samples. Researchers will follow them for up to 5.5 years to see if the test results match whether the cancer returns.

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.

Participants

About 1,800 people

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

Started

Jun 2024

Expected to finish

Apr 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Patients over the age of 18 who will undergo neoadjuvant treatment for high-risk, early breast cancer

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: 1. The participant or a legally authorized representative must provide study-specific informed consent prior to study entry. 2. The participant must be ≥ 18 years of age. 3. ECOG performance status 0 or 1. 4. Histologically confirmed invasive carcinoma of the breast. 5. Planned neoadjuvant therapy which includes cytotoxic chemotherapy. 6. Tumor size ≥ 2.1 cm in greatest diameter. 7. Unifocal or multifocal cancer documented to be the same histologic clinical subtype. 8. Clinically node positive or if node negative, any one of the following: 1. TNBC or HER2+ subtype 2. HR+/HER2-negative with at least one of the following: i. High tumor grade (G3) ii. Ki67 index of 20% or higher iii. High genomic risk (Oncotype DX® (ODX) Breast Recurrence Score of \> 25, MammaPrint® High, etc.) 9. Willing and able to comply with the study requirements, which includes the collection of a total of 34 cc (2.5 Tablespoons) of blood for each research blood draw. 10. Available residual tissue from diagnostic biopsy from the breast or an involved ipsilateral lymph node for submission to create a bespoke ctDNA assay. Exclusion Criteria: 1. Definitive clinical or radiologic evidence of metastatic disease. 2. Initiated neoadjuvant therapy for current breast cancer diagnosis. 3. Synchronous diagnosis of another invasive cancer, other than this breast cancer, except for non-melanoma skin cancers. 4. Completed all therapy (including endocrine therapy) \<5 years ago for any previous invasive solid organ malignancy (with exception of non-melanoma skin cancers) including prior breast cancer. Individuals with a prior history of noninvasive (in situ) carcinomas may participate if they have received definitive treatment. 5. Completed all therapy for any previous hematologic malignancy \< 5 years ago. 6. Multicentric or contralateral invasive breast cancers. 7. Known pregnancy at time of enrollment. 8. Prior solid organ transplant. 9. Prior allogeneic hematopoietic stem cell transplant.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    58 sites in 2 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AdventHealth East Altamonte Oncology and Hematology

    RECRUITING

    Altamonte Springs, Florida, 32701, United States

  • Alan B. Pearson Regional Cancer Center

    RECRUITING

    Lynchburg, Virginia, 24501, United States

  • Atrium Health Levine Cancer Institute

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Atrium Health Wake Forest Baptist Medical Center

    RECRUITING

    Winston-Salem, North Carolina, 27157, United States

  • Aultman Timken Family Cancer Center

    RECRUITING

    Canton, Ohio, 44710, United States

  • Aurora Cancer Care - Wauwatosa

    RECRUITING

    Wauwatosa, Wisconsin, 53226, United States

  • Avera Cancer Institute

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Ballad Health Cancer Center

    RECRUITING

    Kingsport, Tennessee, 37660, United States

  • Baptist Cancer Care - Plantation

    RECRUITING

    Plantation, Florida, 33324, United States

  • Baptist Health Louisville

    RECRUITING

    Louisville, Kentucky, 40207, United States

  • Bon Secours Cancer Institute at St. Francis

    RECRUITING

    Midlothian, Virginia, 23114, United States

  • Centre Hospitalier de l'Université de Montréal (CHUM)

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • Cleveland Clinic Main Campus

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Deaconess Chancellor Center for Oncology

    RECRUITING

    Newburgh, Indiana, 47630, United States

  • FirstHealth Outpatient Cancer Center

    RECRUITING

    Pinehurst, North Carolina, 28374, United States

  • Greater Baltimore Medical Center

    RECRUITING

    Baltimore, Maryland, 21204, United States

  • Guthrie Sayre

    RECRUITING

    Sayre, Pennsylvania, 18840, United States

  • Harbor-UCLA Medical Center - Hematology / Oncology

    RECRUITING

    Torrance, California, 90502, United States

  • Holy Cross Hospital - Silver Spring

    RECRUITING

    Silver Spring, Maryland, 20910, United States

  • Hôpital du Saint-Sacrement

    RECRUITING

    Québec, Quebec, G1S 4L8, Canada

  • James M Stockman Cancer Institute

    RECRUITING

    Frederick, Maryland, 21702, United States

  • Jewish General Hospital

    RECRUITING

    Montreal, Quebec, H3T1E2, Canada

  • Joe Arrington Cancer Research & Treatment Center

    RECRUITING

    Lubbock, Texas, 79410, United States

  • John Theurer Cancer Center

    RECRUITING

    Hackensack, New Jersey, 07601, United States

  • Kaiser Permanente Medical Center

    RECRUITING

    Vallejo, California, 94589, United States

  • Katmai Oncology Group - Anchorage

    RECRUITING

    Anchorage, Alaska, 99508, United States

  • Lahey Hospital & Medical Center

    RECRUITING

    Burlington, Massachusetts, 01805, United States

  • Maisonneuve-Rosemont Hospital (HMR)

    RECRUITING

    Montreal, Quebec, H1T 2M4, Canada

  • McGill University Health - Glen Site

    RECRUITING

    Montreal, Quebec, Canada

  • MedStar Georgetown Cancer Institute

    RECRUITING

    Baltimore, Maryland, 21237, United States

  • Meritus Center for Clinical Research

    RECRUITING

    Hagerstown, Maryland, 21742, United States

  • Metro Minnesota Community Oncology Consortium (MMCORC)

    RECRUITING

    Saint Louis Park, Minnesota, 55426, United States

  • Mount Sinai Medical - Comprehensive Cancer Center

    RECRUITING

    Miami Beach, Florida, 33140, United States

  • Norton Cancer Institute - Downtown

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • Novant Health Cancer Institute - Elizabeth

    RECRUITING

    Charlotte, North Carolina, 28204, United States

  • Penn State Cancer Institute

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Penn State Health Medical Group - Andrews Patel

    RECRUITING

    Harrisburg, Pennsylvania, 17111, United States

  • Rush Cancer Center

    RECRUITING

    Chicago, Illinois, 60607, United States

  • Rutgers Cancer Institute of New Jersey

    RECRUITING

    New Brunswick, New Jersey, 08901, United States

  • Saint Luke's Hospital of Kansas City

    RECRUITING

    Kansas City, Missouri, 64111, United States

  • Sinai Hospital of Baltimore

    RECRUITING

    Baltimore, Maryland, 21215, United States

  • Spartanburg Medical Center

    RECRUITING

    Spartanburg, South Carolina, 29303, United States

  • St. Elizabeth Edgewood Hospital

    RECRUITING

    Edgewood, Kentucky, 41017, United States

  • St. Joseph's Women's Hospital

    RECRUITING

    Tampa, Florida, 33607, United States

  • Stanford Cancer Institute

    RECRUITING

    Palo Alto, California, 94304, United States

  • Stony Brook Medicine

    RECRUITING

    Stony Brook, New York, 11794, United States

  • Tate Cancer Center at UM Baltimore Washington

    RECRUITING

    Glen Burnie, Maryland, 21061, United States

  • The Center for Cancer and Blood Disorders - Bethesda

    RECRUITING

    Bethesda, Maryland, 20818, United States

  • The University of Texas MD Anderson Cancer Center

    RECRUITING

    Houston, Texas, 77030, United States

  • UCHealth Cancer Care - Anschutz Medical Campus - University of Colorado Cancer Center

    RECRUITING

    Aurora, Colorado, 80045, United States

  • UNC Cancer Care at Nash

    RECRUITING

    Rocky Mount, North Carolina, 27804, United States

  • UPMC Magee - Womens Hospital

    RECRUITING

    Pittsburgh, Pennsylvania, 15213, United States

  • University of Kansas Cancer Center

    RECRUITING

    Westwood, Kansas, 66205, United States

  • University of Maryland St. Joseph Medical Center

    RECRUITING

    Towson, Maryland, 21204, United States

  • VCU Massey Comprehensive Cancer Center

    RECRUITING

    Richmond, Virginia, 23298, United States

  • WVU Cancer Institute

    RECRUITING

    Morgantown, West Virginia, 26505, United States

  • Weinberg Center at Mercy

    RECRUITING

    Baltimore, Maryland, 21202, United States

  • Women & Infants Hospital

    RECRUITING

    Providence, Rhode Island, 02905, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.