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Breast NeoplasmsSIGNAL-ER 101NCT07214532

Signatera-Guided CDK4/6 Inhibitor Therapy in Breast Cancer

A study testing ctDNA-Guided Treatment Strategy in people with Breast Neoplasms and Carcinoma, Ductal, Breast, run by Natera, Inc. at 50 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with intermediate-risk HR+/HER2- early-stage breast cancer. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
ctDNA-Guided Treatment Strategy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
725 participants
Where
50 sitesUnited States
Study dates
8 May 2026to 30 Dec 2037
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Signed and dated Informed Consent Form (ICF) obtained prior to any trial-specific screening procedure.
  • Patient is ≥ 18 years-old at the time of ICF signature.
  • Patient is female with known menopausal status at the time of initiation of adjuvant endocrine therapy (ET), or male.
  • 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.
  • 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.
  • 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.
Show all 19Show fewer
  • 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).
  • 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:
  • Patients who received neoadjuvant treatment must meet the criteria for stage, grade, Ki67 in any presurgical staging/sample and/or in the surgical specimen.
  • Categorization into the AJCC 8th edition Anatomic Stage Groups requires determination of the T, N and M categories. ALND can be omitted.
  • Patient has no contraindication to adjuvant ET and is planned to be treated with ET for 5 years (since enrollment date) or more.
  • Provider and patient must be agreeable to initiate CDK4/6 inhibitors only upon ctDNA detection.
  • Patient may have received up to 6 months of standard adjuvant ET at the time of enrollment and any amount of neoadjuvant endocrine therapy.
  • Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
  • Patient must not have a clinical contraindication to ribociclib or abemaciclib.
  • Patient must be willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other trial procedures.
  • Women of childbearing potential (CBP) must have a confirmed negative serum pregnancy test within 14 days prior to enrollment.
  • 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.

Who cannot join

  • Patient has had prior exposure to a CDK4/6 inhibitor.
  • Patient is concurrently using hormone replacement therapy.
  • Patient with a known contraindication or hypersensitivity to ribociclib or abemaciclib as per the FDA indication label.
  • Patients with a multicentric and/or multifocal and synchronous contralateral breast cancer are ineligible.
  • 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.
  • 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.
  • 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.
  • 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.

Trial locations and contacts

50 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Chelsea Nihill, MS contact

706-726-6935

signaler@natera.com

Jessica Reyes, BS contact

844-778-4700

signaler@natera.com

50 sites in 1 country

United States50 sites, 50 recruiting

  • New Mexico Oncology & Hematology Consultants

    Albuquerque, New Mexico, 87109

    Sofia Palacio, MD, 505-842-8171, research@nmohc.com

    Katherine Sanchez

    Recruiting

  • New York Cancer and Blood Specialists

    Babylon, New York, 11702

    Research Recruitment, researchrecruitment@nycancer.com

    Richard Zuniga

    Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

    Arielle Medford

    Not yet recruiting

  • Cooper Health

    Camden, New Jersey, 08103

    Kamel Abou-Hussein, MD

    Not yet recruiting

  • Atrium Levine Cancer Institute

    Charlotte, North Carolina, 28204

    Arielle Heeke, MD

    Not yet recruiting

  • Northwestern University

    Chicago, Illinois, 60611

    Nicole Grzywacz, 312-695-1310, nicole.grzywacz@northwestern.edu

    William Gradishar, MD

    Not yet recruiting

  • Cleveland Clinic

    Cleveland, Ohio, 44195

    Cancer Answer Line, 216-444-7923, Canceranswer@ccf.org

    Azka Ali

    Not yet recruiting

  • Karmanos Cancer Center - Wayne State University

    Detroit, Michigan, 48201

    Allison Wolgast

    Jailan Elayoubi

    Not yet recruiting

  • Northwest Cancer Center

    Dyer, Indiana, 46311

    Mariela Abad, Mariela.Abad@usoncology.com

    Shruti Singh, MD

    Recruiting

  • Inova

    Fairfax, Virginia, 33021

    Takada Harris, 571-472-4724, takada.harris@inova.org

    Melissa Yacur

    Not yet recruiting

  • West Cancer Center

    Germantown, Tennessee, 38138

    Karen Axley

    Gary Tian, MD

    Not yet recruiting

  • Intermountain Health

    Grand Junction, Colorado, 81501

    Heidi Kaiser, 970-298-6576, heidi.kaiser@imail.org

    Alicia Swink

    Not yet recruiting

  • Cancer & Hematology Centers

    Grand Rapids, Michigan, 49504

    Maci DeBoar, 616-954-5550 ext. 1925, mdeboer@thechc.com

    Haritha Reddy

    Recruiting

  • Marin Cancer Care

    Greenbrae, California, 94904

    Jaime Chung, 415-925-5040, jchang@marincancercare.com

    Cyrus Mazidi, MD

    Recruiting

  • Hartford Healthcare Institute

    Hartford, Connecticut, 06102

    Richard Zelkowitz, MD

    Not yet recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Akshjot Puri, MD

    Not yet recruiting

  • Oncology Consultants

    Houston, Texas, 77030

    Julio Peguero, 713-600-0900, Jpeguero@oncologyconsultants.com

    Roberto Alvarez, MD

    Not yet recruiting

  • Indiana University

    Indianapolis, Indiana, 46202

    Bryan Schneider

    Not yet recruiting

  • Baptist MD Anderson

    Jacksonville, Florida, 32207

    CTOInterest@bmcjax.com

    Dayra Avila-Lima, MD

    Recruiting

  • Mayo Clinic Florida

    Jacksonville, Florida, 32224

    Mayo Clinic Comprehensive Cancer Center, 904-953-2000, CANCERCTR@mayo.edu

    Pooja Advani, MD

    Not yet recruiting

  • Jupiter Medical Cancer

    Jupiter, Florida, 33458

    Nancy Nahmias, 561-263-5791, Nancy.Nahmias@jupitermed.com

    Danielle Krol, MD

    Recruiting

  • Loma Linda University

    Loma Linda, California, 92354

    Gayathri Nagaraj, MD

    Not yet recruiting

  • Cancer and Blood Research Center

    Los Alamitos, California, 90720

    John Wong

    Not yet recruiting

  • University of Wisconsin

    Madison, Wisconsin, 53792

    Briana Barrow, 318-212-8671, bbarrow@wkhs.com

    Kari Wisinski

    Not yet recruiting

  • Werheim Cancer Institute

    Miami, Florida, 33176

    Amy Starosciak, PhD., 786-527-9546, AmySt@BaptistHealth.net

    Reshma Mahtani, DO

    Not yet recruiting

  • West Virginia University

    Morgantown, West Virginia, 26506

    Kaitlyn Hager, 304-293-0609, kaitlyn.hager@hsc.wvu.edu

    Bei Jiang, MD

    Recruiting

  • Vanderbilt

    Nashville, Tennessee, 37232

    Brent Rexer, MD

    Not yet recruiting

  • Rutgers

    New Brunswick, New Jersey, 08901

    Stephanie Farias

    Mridula George, MD

    Not yet recruiting

  • Yale Cancer Center

    New Haven, Connecticut, 06520

    Carl Brown, 475-241-1065, carl.brown@yale.edu

    Lajos Pusztai, MD

    Not yet recruiting

  • NYU Langone Health

    New York, New York, 10016

    Nancy Chan

    Not yet recruiting

  • Ocala Oncology

    Ocala, Florida, 34474

    Snjit Nirmalanandhan, 352-547-1958, Sanjit.Nirmalanandhan@usoncology.com

    Rama Balaraman, MD

    Recruiting

  • Mayo Clinic Arizona

    Phoenix, Arizona, 85054

    Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu

    Shakeela Bahadur, MD

    Not yet recruiting

  • Allegheny (AHN)

    Pittsburgh, Pennsylvania, 15212

    AHN Clinical Trial Contact, 412-325-5700, clinicaltrials@ahn.org

    Joseph Liput, MD

    Not yet recruiting

  • Northwest Medical Specialties, PLLC

    Puyallup, Washington, 98373

    Sibel Blau, MD

    Recruiting

  • Mayo Clinic

    Rochester, Minnesota, 55905

    Clinical Trials Referral Office, 855-776-0015

    Karthik Giridhar, MD

    Not yet recruiting

  • University of Rochester (URMC)

    Rochester, New York, 14642

    Susan Dent, MD, 585-275-4401, Susan_Dent@URMC.Rochester.edu

    Susan Dent

    Not yet recruiting

  • UCLA David Geffen School of Medicine

    Santa Monica, California, 90404

    Ruth Gonzalez, 424-320-1756, Rngonzalez@mednet.ucla.edu

    Marla Lipsyc-Sharf, MD

    Not yet recruiting

  • Honor Health Research Institute

    Scottsdale, Arizona, 85258

    Nathan Solod, 480-295-9344, nsolod@honorhealth.com

    Abhimanyu Ghose, MD

    Not yet recruiting

  • Fred Hutch Cancer Center

    Seattle, Washington, 98109

    Lynn Symonds, MD

    Not yet recruiting

  • Willis Knighton Cancer Center

    Shreveport, Louisiana, 71103

    Prakash Peddi, MD

    Not yet recruiting

  • Sanford Health

    Sioux Falls, South Dakota, 57104

    Allison Watson, MD

    Not yet recruiting

  • Mercy Health - Sindelar Cancer Center

    St Louis, Missouri, 63128

    Danielle Werle, 314-525-6042, Danielle.Werle@Mercy.Net

    Yifan Tu, MD

    Not yet recruiting

  • Mercy Health - Pratt Cancer Center

    St Louis, Missouri, 63141

    Andrea Llewellyn, 314-251-6445, andrea.llewellyn@Mercy.Net

    Bethany Sleckman, MD

    Not yet recruiting

  • Stockton Hematology Oncology Medical Group

    Stockton, California, 95204

    Lakshmi Nilyat, 209-466-2626, lnilyat@shomg.net

    Ajithkumar Puthillath, MD

    Recruiting

  • Stony Brook Cancer Center

    Stony Brook, New York, 11794

    Alison Stopeck

    Not yet recruiting

  • MultiCare Cancer Institute

    Tacoma, Washington, 98405

    Beth Parker, 509-746-3222, Beth.Parker@multicare.org

    Blair Irwin, MD

    Recruiting

  • Munson Medical Center Cowell Family Cancer Center

    Traverse City, Michigan, 49684

    Brook Wright, 231-213-0584, CFCC-CancerResearch@mhc.net

    Yelena Kier, DO

    Recruiting

  • University of Arizona Cancer Center

    Tucson, Arizona, 85719

    Lizeth Evangelista, 520-694-2873, levangelista@arizona.edu

    Sima Ehsani, MD

    Not yet recruiting

  • Kaiser Permanente NorCal

    Vallejo, California, 94589

    Jennifer Suga, MD

    Not yet recruiting

  • New England Cancer Specialists

    Westbrook, Maine, 04092

    Chiara Battelli, MD, 207-303-3300, research@newecs.org

    Chiara Battelli, MD

    Recruiting

Other trials in United States

About this study

Official title: SIgnatera-Guided Initiation of Adjuvant CDK4/6 Inhibitor in Intermediate Risk HR+ HER2- Breast Cancer

The purpose of this study is to evaluate the efficacy and safety of ctDNA-guided initiation of CDK4/6 inhibitor therapy using the Signatera™ Designed on Genome test (referred to as "Signatera Genome") in participants with intermediate-risk HR+/HER2- early-stage breast cancer. Based on ctDNA test results, participants will either start CDK4/6 inhibitor therapy in addition to hormone therapy or continue hormone therapy with ongoing ctDNA surveillance. This study will compare outcomes to historical controls from the NataLEE trial to determine whether ctDNA-guided timing maintains efficacy while reducing unnecessary treatment. Participants will be followed for up to 9 years with regular blood draws, hormone therapy, imaging as needed, and quality-of-life assessments.

Read the detailed description

Participants with intermediate-risk, early-stage HR+/HER2- breast cancer will be enrolled in a prospective, single-arm, multicenter phase II study. Circulating tumor DNA (ctDNA) surveillance will be performed using the Signater Genome assay, which is customized for each participant from archived tumor and matched normal DNA to detect up to 64 tumor-specific variants in plasma.

Participants who are ctDNA positive at baseline will start CDK4/6 inhibitor therapy along with hormone therapy. Those who are ctDNA negative will continue hormone therapy with ctDNA testing every three months. If ctDNA becomes positive during surveillance, participants will first undergo staging to rule out distant disease before beginning CDK4/6 inhibitor therapy in addition to hormone therapy.

All participants will be followed for up to nine years to assess cancer outcomes. Four-year outcomes will be compared to historical controls from the NataLEE trial to evaluate whether ctDNA-guided timing maintains efficacy while reducing unnecessary treatment.

Being tested
ctDNA-Guided Treatment Strategy
Keywords
ctDNA, Circulating tumor DNA, Signatera, CDK4/6 inhibitor, Ribociclib, Abemaciclib, Molecular residual disease, MRD, Biomarker-guided therapy, Adjuvant therapy, Hormone receptor positive, HER2 negative, Early breast cancer, Intermediate risk breast cancer, breast cancer, Endocrine therapy, Tumor-informed assay
Medical subject headings
Breast Neoplasms, Carcinoma, Ductal, Breast

What participants receive

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

  • ctDNA-Guided Treatment StrategyDevice

    Circulating tumor DNA testing using Signatera Genome assay is performed every 3 months for up to 4 years to guide timing of CDK4/6 inhibitor initiation. Participants with positive ctDNA results initiate CDK4/6 inhibitor therapy (ribociclib or abemaciclib) plus standard endocrine therapy for a minimum of 2 years. Participants with negative ctDNA results continue endocrine therapy alone with ongoing surveillance. CDK4/6 inhibitor selection and endocrine therapy regimen per the physician's choice following standard-of-care guidelines.

Study groups in NCT07214532
Study groupRoleWhat they receive
ctDNA-Guided TherapyExperimentalAll participants receive circulating tumor DNA (ctDNA) testing using Signatera Genome every 3 months to guide treatment decisions. Participants with positive ctDNA results initiate CDK4/6 inhibitor therapy (ribociclib or abemaciclib) in addition to standard endocrine therapy. Participants with negative ctDNA results continue endocrine therapy alone with ongoing ctDNA surveillance. All participants continue their assigned treatment pathway until disease progression, unacceptable toxicity, or study completion.
Receives: Device: ctDNA-Guided Treatment Strategy

What is being measured

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

  1. Invasive Disease-Free Survival

    The primary objective of this study is to to evaluate disease free survival (iDFS) in patients with intermediate risk breast cancer receiving standard endocrine therapy with the addition of CDK4/6 inhibitor therapy upon positive ctDNA test results as compared to historical data of treated patients (NataLEE).

    Measured: From the date of surgery up to 9 years

Timeline

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

  1. First posted9 Oct 2025
  2. Study start8 May 2026
  3. Primary completion15 May 2032 (estimated)
  4. Study completion30 Dec 2037 (estimated)

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This single-arm study uses circulating tumor DNA (ctDNA) testing to guide individualized treatment decisions. All participants undergo ctDNA surveillance every 3 months, with treatment pathways determined by test results rather than randomization. Participants with positive ctDNA receive CDK4/6 inhibitor therapy plus endocrine therapy, while those with negative results continue endocrine therapy alone with ongoing surveillance. Outcomes are compared to historical controls from the NataLEE trial using a non-inferiority design.
Masking
None (open label)
Enrolment
725 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07214532
Sponsor's protocol ID
25-085-NCP
Acronym
SIGNAL-ER 101
Status last verified
Sep 2026
First submitted
24 Sep 2025
Last updated
5 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Cohen SA, Liu MC, Aleshin A. Practical recommendations for using ctDNA in clinical decision making. Nature. 2023 Jul;619(7969):259-268. doi: 10.1038/s41586-023-06225-y. Epub 2023 Jul 12.

    PubMed 37438589

  • Kanjanapan Y, Anderson W, Smith M, Green J, Chalker E, Craft P. Real-World Analysis of Breast Cancer Patients Qualifying for Adjuvant CDK4/6 Inhibitors. Clin Breast Cancer. 2025 Feb;25(2):e159-e169.e2. doi: 10.1016/j.clbc.2024.08.022. Epub 2024 Aug 29.

    PubMed 39294027

  • Magbanua MJM, Brown Swigart L, Ahmed Z, Sayaman RW, Renner D, Kalashnikova E, Hirst GL, Yau C, Wolf DM, Li W, Delson AL, Asare S, Liu MC, Albain K, Chien AJ, Forero-Torres A, Isaacs C, Nanda R, Tripathy D, Rodriguez A, Sethi H, Aleshin A, Rabinowitz M, Perlmutter J, Symmans WF, Yee D, Hylton NM, Esserman LJ, DeMichele AM, Rugo HS, van 't Veer LJ. Clinical significance and biology of circulating tumor DNA in high-risk early-stage HER2-negative breast cancer receiving neoadjuvant chemotherapy. Cancer Cell. 2023 Jun 12;41(6):1091-1102.e4. doi: 10.1016/j.ccell.2023.04.008. Epub 2023 May 4.

    PubMed 37146605

  • Cutts R, Ulrich L, Beaney M, Robert M, Coakley M, Bunce C, Crestani GW, Hrebien S, Kalashnikova E, Wu HT, Dashner S, Sethi H, Aleshin A, Liu M, Ring A, Okines A, Smith IE, Barry P, Turner NC, Garcia-Murillas I. Association of post-operative ctDNA detection with outcomes of patients with early breast cancers. ESMO Open. 2024 Sep;9(9):103687. doi: 10.1016/j.esmoop.2024.103687. Epub 2024 Aug 30.

    PubMed 39216186

  • Natarajan A, Tolaney SM. Is adjuvant ribociclib ready for prime time? Ann Oncol. 2024 Dec;35(12):1200-1201. doi: 10.1016/j.annonc.2024.08.2341. Epub 2024 Sep 4. No abstract available.

    PubMed 39241962

  • Johnston SRD, Harbeck N, Toi M, Martin M, O'Shaughnessy J, Rastogi P. Reply to K. Hashimoto and A. Shimomura. J Clin Oncol. 2021 May 1;39(13):1507-1508. doi: 10.1200/JCO.20.03477. Epub 2021 Feb 25. No abstract available.

    PubMed 33630658

  • Kay C, Martinez-Perez C, Dixon JM, Turnbull AK. The Role of Nodes and Nodal Assessment in Diagnosis, Treatment and Prediction in ER+, Node-Positive Breast Cancer. J Pers Med. 2023 Oct 8;13(10):1476. doi: 10.3390/jpm13101476.

    PubMed 37888087

  • Nelson DR, Brown J, Morikawa A, Method M. Breast cancer-specific mortality in early breast cancer as defined by high-risk clinical and pathologic characteristics. PLoS One. 2022 Feb 25;17(2):e0264637. doi: 10.1371/journal.pone.0264637. eCollection 2022.

    PubMed 35213669

  • Smolarz B, Nowak AZ, Romanowicz H. Breast Cancer-Epidemiology, Classification, Pathogenesis and Treatment (Review of Literature). Cancers (Basel). 2022 May 23;14(10):2569. doi: 10.3390/cancers14102569.

    PubMed 35626173

  • Siegel RL, Kratzer TB, Giaquinto AN, Sung H, Jemal A. Cancer statistics, 2025. CA Cancer J Clin. 2025 Jan-Feb;75(1):10-45. doi: 10.3322/caac.21871. Epub 2025 Jan 16.

    PubMed 39817679

Questions about this trial

What is this clinical trial studying?

A study testing ctDNA-Guided Treatment Strategy in people with Breast Neoplasms and Carcinoma, Ductal, Breast, run by Natera, Inc. at 50 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 19 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 5 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 50 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Chelsea Nihill, MS (706-726-6935, signaler@natera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invasive Disease-Free Survival (time frame: From the date of surgery up to 9 years). 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 NCT07214532, which also lists 10 linked publications.

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 5 Nov 2026.

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