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New hope for endometrial cancer: targeted drug trial launches

NCT ID NCT07022483

Disease control Sponsor: Daiichi Sankyo 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jul 29, 2026 · Updated 3 times

Summary

This phase 3 trial tests whether the targeted drug trastuzumab deruxtecan (T-DXd) works better than standard chemotherapy after surgery for HER2-positive endometrial cancer. About 710 adults with early-stage or locally advanced disease will be randomly assigned to receive T-DXd or chemo, with or without radiation. The main goal is to see if T-DXd helps keep cancer from coming back.

What this could mean

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

Active substance
trastuzumab deruxtecan (T-DXd, Enhertu)
What this could lead to
If successful, this could offer a more effective adjuvant treatment for HER2-positive endometrial cancer, potentially reducing the risk of cancer returning after surgery.
What could go wrong
This is a phase 3 trial, but results are not guaranteed. The new drug may not outperform standard chemo, and side effects like lung inflammation or heart problems are possible.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 710 people

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

Started

Sep 2025

Expected to finish

Mar 2032

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

Female participants only

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.

Key Inclusion Criteria * Adults ≥18 years at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation is \>18 years old) * Has histologically confirmed diagnosis of epithelial endometrial carcinoma. All histology's are allowed except for sarcomas (carcinosarcomas are allowed). * Is newly diagnosed FIGO 2023 Stage IIC (including Stage IICmp53abn) or Stage III Note: FIGO 2023 Stage IIC includes disease with aggressive histological types (aggressive histological types are composed of high-grade EECs (grade 3), serous, clear cell, undifferentiated, mixed, mesonephric-like, gastrointestinal mucinous type carcinomas, and carcinosarcomas) with any myometrial involvement. FIGO 2023 Stage III includes disease with local and/or regional spread of the tumor of any histological subtype. * Has HER2-expression (IHC 3+/2+) per 2016 ASCO-CAP gastric cancer IHC scoring guidelines as confirmed by central laboratory testing. * Has adequate archived tumor tissue sample (sample from surgery is strongly recommended) available for assessment of HER2 status by central laboratory. Key Exclusion Criteria * Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas. Adenosarcomas are also not allowed. * Has recurrent or FIGO 2023 Stage IV * Has measurable residual tumor after surgery as determined by BICR assessment. * Is known to have a POLE mutation from an approved and/or validated local test, according to local regulations, if available * Has a medical history of MI within 6 months before randomization/enrollment, symptomatic CHF (NYHA Class II to IV). Participants with troponin levels above ULN at SCR (as defined by the manufacturer), and without any MI related symptoms should have a cardiologic consultation during SCR Period to rule out MI. * Has a QTcF prolongation to \> 480 msec based on average of the SCR triplicate12-lead ECG. Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses including, but not limited to, any underlying pulmonary disorder (ie, pulmonary emboli within 3 months of the trial enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion, etc.) and any autoimmune, connective tissue, or inflammatory disorder with potential pulmonary involvement (eg, rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy. * Has a history of (noninfectious) ILD/pneumonitis that required corticosteroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at SCR.

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Conditions

The condition(s) this trial relates to.

endometrial cancer endometrial carcinoma endometrium neoplasm neoplasm

As listed by the trial registrant

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

Endometrial cancer

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    75 sites in 13 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Avera Medical Group Gynecologic Oncology Sioux Falls

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Azienda Ospedaliera Universitaria Careggi

    RECRUITING

    Florence, 50134, Italy

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS

    RECRUITING

    Bologna, 40138, Italy

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, China

  • Biocenter

    RECRUITING

    Concepción, 4070196, Chile

  • Broward Health Medical Center

    RECRUITING

    Fort Lauderdale, Florida, 33316, United States

  • CER San Juan Centro Polivalente de Asistencia e Inv. Clinica

    RECRUITING

    San Juan, 5400, Argentina

  • Cancer Hospital of Shandong First Medical University

    RECRUITING

    Jinan, China

  • Cancer Institute Hospital of JFCR

    RECRUITING

    Kōtoku, Japan

  • Centre Francois Baclesse

    RECRUITING

    Caen, 14076, France

  • Centre Jean Perrin - CLCC

    RECRUITING

    Clermont-Ferrand, 63000, France

  • Centro de Estudios Clinicos SAGA

    RECRUITING

    Santiago, 7500653, Chile

  • Centro de Investigaciones Clinicas de la Universidad Catolica

    RECRUITING

    Santiago, 8330034, Chile

  • Centro de Investigaciones Medicas Mar del Plata

    RECRUITING

    Mar del Plata, B7600, Argentina

  • Complejo Hospitalario Universitario A Coruña

    RECRUITING

    A Coruña, 15006, Spain

  • FirstHealth of the Carolinas, Inc.

    RECRUITING

    Pinehurst, North Carolina, 28374, United States

  • Fukushima Medical University Hospital

    RECRUITING

    Fukushima, Japan

  • Guangxi Medical University Affiliated Tumor Hospital

    RECRUITING

    Nanning, China

  • Gunma Prefectural Cancer Center

    RECRUITING

    Ota-shi, Japan

  • Hospital Italiano de Buenos Aires

    RECRUITING

    Ciudad Autonoma Buenos Aires, C1199, Argentina

  • Hospital Universitari Son Espases

    RECRUITING

    Palma de Mallorca, 07120, Spain

  • Hospital Universitario 12 de Octubre

    RECRUITING

    Madrid, 28041, Spain

  • Hospital Universitario La Paz

    RECRUITING

    Madrid, 28046, Spain

  • Hospital Universitario Ramon y Cajal

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitario Virgen de la Arrixaca

    RECRUITING

    El Palmar, 30120, Spain

  • Hospital da Luz

    RECRUITING

    Lisbon, 1500-650, Portugal

  • Hyogo Cancer Center

    RECRUITING

    Akashi-shi, Japan

  • IEO Istituto Europeo di Oncologia

    RECRUITING

    Milan, 20141, Italy

  • Institut Claudius Regaud

    RECRUITING

    Toulouse, 31059, France

  • Instituto de Oncologia de Rosario

    RECRUITING

    Rosario, 2000, Argentina

  • Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari

    RECRUITING

    Bari, 70124, Italy

  • Jiangxi Maternal and Child Health Hospital

    RECRUITING

    Nanchang, China

  • Keimyung University Dongsan Hospital

    RECRUITING

    Daegu, South Korea

  • Keio University Hospital

    RECRUITING

    Shinjuku-ku, Japan

  • Klinikum Lippe-Detmold

    RECRUITING

    Detmold, 32756, Germany

  • Kurume University Hospital

    RECRUITING

    Kurume-shi, Japan

  • Linyi Cancer Hospital

    RECRUITING

    Linyi, China

  • Miami Cancer Institute

    RECRUITING

    Miami, Florida, 33176, United States

  • Mie University Hospital

    RECRUITING

    Tsu, Japan

  • Mount Sinai Medical Center

    RECRUITING

    Miami Beach, Florida, 33140, United States

  • NHO Hokkaido Cancer Center

    RECRUITING

    Sapporo, Japan

  • NHO Kyushu Cancer Center

    RECRUITING

    Fukuoka, Japan

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, Taiwan

  • National Taiwan University Hospital

    RECRUITING

    Taipei, Taiwan

  • Niigata Cancer Center Hospital

    RECRUITING

    Niigata, Japan

  • Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, China

  • Okayama University Hospital

    RECRUITING

    Okayama, Japan

  • Ospedale Mauriziano Umberto I

    RECRUITING

    Torino, 10128, Italy

  • Parkview Research Center

    RECRUITING

    Fort Wayne, Indiana, 46845, United States

  • Presidio Ospedaliero Alessandro Manzoni di Lecco

    RECRUITING

    Lecco, 23900, Italy

  • Saitama Medical University International Medical Center

    RECRUITING

    Hidaka-shi, Japan

  • Samsung Medical Center

    RECRUITING

    Seoul, South Korea

  • Sanatorio Allende Cerro

    RECRUITING

    Córdoba, X5021FPQ, Argentina

  • Seoul National University Hospital

    RECRUITING

    Seoul, South Korea

  • Shanghai First Maternity and Infant HospitalShanghai First Maternity and Infant Hospital

    RECRUITING

    Shanghai, China

  • Shanghai Tenth People's Hospital

    RECRUITING

    Shanghai, China

  • Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością

    RECRUITING

    Gdynia, 81-519, Poland

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, Taiwan

  • Taipei Veterans General Hospital

    RECRUITING

    Taipei, Taiwan

  • Texas Oncology San Antonio Medical Center

    RECRUITING

    San Antonio, Texas, 78240, United States

  • Texas Oncology, P.A. - Tyler

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • The First Affiliated Hospital of Wenzhou Medical University

    RECRUITING

    Wenzhou, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, China

  • Tianjin Medical University Cancer Institute & Hospital

    RECRUITING

    Tianjin, China

  • Tohoku University Hospital

    RECRUITING

    Sendai, Japan

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology

    RECRUITING

    Wuhan, China

  • Trials365 LLC

    RECRUITING

    Shreveport, Louisiana, 71103, United States

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    RECRUITING

    Wuhan, China

  • Universitatsklinikum Frankfurt

    RECRUITING

    Frankfurt, 60596, Germany

  • University of Cincinnati Physicians Group, LLC

    RECRUITING

    Cincinnati, Ohio, 45206, United States

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    RECRUITING

    Poznan, 60-569, Poland

  • West China Second University Hospital, Sichuan University

    RECRUITING

    Chengdu, China

  • Yamagata University Hospital

    RECRUITING

    Yamagata, Japan

  • Yantai Yuhuangding Hospital

    RECRUITING

    Yantai, China

  • Zhejiang Cancer Hospital

    RECRUITING

    Hangzhou, China

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