Blood test could spare thousands from unnecessary breast cancer treatment

NCT ID NCT07214532

Disease control Sponsor: Natera, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 4 times

Summary

This study is testing whether a simple blood test that looks for cancer DNA can help doctors decide when to start a targeted therapy (CDK4/6 inhibitor) in people with intermediate-risk HR+ HER2- breast cancer. About 725 participants will have their blood tested every 3 months for up to 4 years. If the test finds cancer DNA, they start the targeted drug plus hormone therapy; if not, they continue hormone therapy alone. The goal is to see if this approach works as well as treating everyone upfront, while avoiding unnecessary side effects.

What this could mean

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

Active substance: CDK4/6 inhibitor (ribociclib or abemaciclib) plus endocrine therapy
What this could lead to: If successful, this approach could allow doctors to start targeted therapy only when cancer DNA appears in the blood, potentially sparing many patients from unnecessary treatment while still controlling the disease.
What could go wrong: This is an early-stage study comparing results to historical data, not a randomized trial. The ctDNA test may not catch all recurrences, and the added therapy carries risks like fatigue and low blood counts.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 725 people

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

Started

May 2026

Expected to finish

Dec 2037

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.

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. Signed and dated Informed Consent Form (ICF) obtained prior to any trial-specific screening procedure. 2. Patient is ≥ 18 years-old at the time of ICF signature. 3. Patient is female with known menopausal status at the time of initiation of adjuvant endocrine therapy (ET), or male. 4. Patient with histologically confirmed unilateral and unifocal primary invasive adenocarcinoma of the breast prior to initiating adjuvant chemotherapy, if indicated, or within 6 months of initiating adjuvant endocrine therapy if chemotherapy is not indicated. Patients who receive neoadjuvant endocrine therapy or chemotherapy are allowed to enroll. 5. Patient has breast cancer that is positive for ER and/or PR according to the local laboratory as determined on the most recently analyzed tissue sample. 6. Patient has HER2-negative breast cancer defined as a negative in situ hybridization test (FISH, CISH, or SISH) or an immunohistochemistry (IHC) status of 0 or 1+. If IHC is 2+, a negative in situ hybridization (ISH) test is required to confirm the HER2-negative status. 7. Patient has available archival tumor tissue from the diagnostic biopsy or surgical specimen, for submission to a central laboratory for Signatera testing (unless Signatera Genome clinical testing has already been performed). 8. Patient after surgical resection where tumor was removed completely (i.e., negative microscopic margins on final pathology) and have Anatomic Stage II that is eligible for adjuvant CDK4/6 inhibitors. The criteria to be eligible for adjuvant CDK4/6 inhibitors include N1, or N0 with T3 or T2 with either G3, or G2 with Ki67 greater or equal to 20% or high genomic risk score. Notes: 1. Patients who received neoadjuvant treatment must meet the criteria for stage, grade, Ki67 in any presurgical staging/sample and/or in the surgical specimen. 2. Categorization into the AJCC 8th edition Anatomic Stage Groups requires determination of the T, N and M categories. ALND can be omitted. 9. Patient has no contraindication to adjuvant ET and is planned to be treated with ET for 5 years (since enrollment date) or more. 10. Provider and patient must be agreeable to initiate CDK4/6 inhibitors only upon ctDNA detection. 11. Patient may have received up to 6 months of standard adjuvant ET at the time of enrollment and any amount of neoadjuvant endocrine therapy. 12. Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 13. Patient must not have a clinical contraindication to ribociclib or abemaciclib. 14. Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures. 15. Women of childbearing potential (CBP) must have a confirmed negative serum pregnancy test within 14 days prior to enrollment. 16. Women of reproductive potential should be advised of the potential risk of CDK4/6 inhibitors to a fetus, and use effective contraception during CDK 4/6 inhibitor therapy. Exclusion Criteria: 1. Patient has had prior exposure to a CDK4/6 inhibitor. 2. Patient is concurrently using hormone replacement therapy. 3. Patient with a known contraindication or hypersensitivity to ribociclib or abemaciclib as per the FDA indication label. 4. Patients with a multicentric and/or multifocal and synchronous contralateral breast cancer are ineligible. 5. Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery. 6. Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 5 years before ICF signature. Note: Patients with prior or concurrent in situ malignancies are eligible provided that adequate curative treatment is completed prior to enrollment. 7. Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol (e.g. chronic pancreatitis, chronic active hepatitis, liver cirrhosis or any other significant liver disease, active untreated or uncontrolled fungal, bacterial or viral infections, active infection requiring systemic antibacterial therapy, etc.) or limit life expectancy to ≤5 years. 8. Patient participated in another interventional study and received treatment with an investigational product (or used an investigational device) within 30 days prior to enrollment or within 5 half-lives of the investigational product, whichever is longer.

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Conditions

The condition(s) this trial relates to.

breast ductal adenocarcinoma breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Breast neoplasms Carcinoma, ductal, breast Receptors, estrogen (for ER-positive requirement)

How to take part

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

The places running it

49 sites. The list below names each one and where it is.
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 ↗
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

Allegheny (AHN)
NOT_YET_RECRUITING

Pittsburgh, Pennsylvania, 15212, United States
Atrium Levine Cancer Institute
NOT_YET_RECRUITING

Charlotte, North Carolina, 28204, United States
Baptist MD Anderson
RECRUITING

Jacksonville, Florida, 32207, United States
Cancer & Hematology Centers
NOT_YET_RECRUITING

Grand Rapids, Michigan, 49504, United States
Cancer and Blood Research Center
NOT_YET_RECRUITING

Los Alamitos, California, 90720, United States
Cleveland Clinic
NOT_YET_RECRUITING

Cleveland, Ohio, 44195, United States
Cooper Health
NOT_YET_RECRUITING

Camden, New Jersey, 08103, United States
Fred Hutch Cancer Center
NOT_YET_RECRUITING

Seattle, Washington, 98109, United States
Hartford Healthcare Institute
NOT_YET_RECRUITING

Hartford, Connecticut, 06102, United States
Honor Health Research Institute
NOT_YET_RECRUITING

Scottsdale, Arizona, 85258, United States
Houston Methodist Hospital
NOT_YET_RECRUITING

Houston, Texas, 77030, United States
Indiana University
NOT_YET_RECRUITING

Indianapolis, Indiana, 46202, United States
Inova
NOT_YET_RECRUITING

Fairfax, Virginia, 33021, United States
Intermountain Health
NOT_YET_RECRUITING

Grand Junction, Colorado, 81501, United States
Jupiter Medical Cancer
RECRUITING

Jupiter, Florida, 33458, United States
Kaiser Permanente NorCal
NOT_YET_RECRUITING

Vallejo, California, 94589, United States
Karmanos Cancer Center - Wayne State University
NOT_YET_RECRUITING

Detroit, Michigan, 48201, United States
Loma Linda University
NOT_YET_RECRUITING

Loma Linda, California, 92354, United States
Marin Cancer Care
NOT_YET_RECRUITING

Greenbrae, California, 94904, United States
Massachusetts General Hospital
NOT_YET_RECRUITING

Boston, Massachusetts, 02114, United States
Mayo Clinic
NOT_YET_RECRUITING

Rochester, Minnesota, 55905, United States
Mayo Clinic Arizona
NOT_YET_RECRUITING

Phoenix, Arizona, 85054, United States
Mayo Clinic Florida
NOT_YET_RECRUITING

Jacksonville, Florida, 32224, United States
Mercy Health - Pratt Cancer Center
NOT_YET_RECRUITING

St Louis, Missouri, 63141, United States
Mercy Health - Sindelar Cancer Center
NOT_YET_RECRUITING

St Louis, Missouri, 63128, United States
MultiCare Cancer Institute
RECRUITING

Tacoma, Washington, 98405, United States
Munson Medical Center Cowell Family Cancer Center
NOT_YET_RECRUITING

Traverse City, Michigan, 49684, United States
NYU Langone Health
NOT_YET_RECRUITING

New York, New York, 10016, United States
New England Cancer Specialists
NOT_YET_RECRUITING

Westbrook, Maine, 04092, United States
New Mexico Oncology & Hematology Consultants
NOT_YET_RECRUITING

Albuquerque, New Mexico, 87109, United States
New York Cancer and Blood Specialists
RECRUITING

Babylon, New York, 11702, United States
Northwest Cancer Center
RECRUITING

Dyer, Indiana, 46311, United States
Northwest Medical Specialties, PLLC
RECRUITING

Puyallup, Washington, 98373, United States
Northwestern University
NOT_YET_RECRUITING

Chicago, Illinois, 60611, United States
Ocala Oncology
RECRUITING

Ocala, Florida, 34474, United States
Rutgers
NOT_YET_RECRUITING

New Brunswick, New Jersey, 08901, United States
Sanford Health
NOT_YET_RECRUITING

Sioux Falls, South Dakota, 57104, United States
Stockton Hematology Oncology Medical Group
RECRUITING

Stockton, California, 95204, United States
Stony Brook Cancer Center
NOT_YET_RECRUITING

Stony Brook, New York, 11794, United States
UCLA David Geffen School of Medicine
NOT_YET_RECRUITING

Santa Monica, California, 90404, United States
University of Arizona Cancer Center
NOT_YET_RECRUITING

Tucson, Arizona, 85719, United States
University of Rochester (URMC)
NOT_YET_RECRUITING

Rochester, New York, 14642, United States
University of Wisconsin
NOT_YET_RECRUITING

Madison, Wisconsin, 53792, United States
Vanderbilt
NOT_YET_RECRUITING

Nashville, Tennessee, 37232, United States
Werheim Cancer Institute
NOT_YET_RECRUITING

Miami, Florida, 33176, United States
West Cancer Center
NOT_YET_RECRUITING

Germantown, Tennessee, 38138, United States
West Virginia University
NOT_YET_RECRUITING

Morgantown, West Virginia, 26506, United States
Willis Knighton Cancer Center
NOT_YET_RECRUITING

Shreveport, Louisiana, 71103, United States
Yale Cancer Center
NOT_YET_RECRUITING

New Haven, Connecticut, 06520, United States

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