Endometrial CancerPhase 3NCT07022483
A Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer in Adjuvant Setting
A Phase 3 study testing Trastuzumab Deruxtecan and Chemotherapy in people with Endometrial Cancer, run by Daiichi Sankyo at 86 sites in 15 countries.
Trial summary
This study is designed to assess efficacy and safety of T-DXd adjuvant therapy, with or without radiotherapy, post-surgery in anticancer treatment naïve (including neoadjuvant therapy) endometrial cancer with various HER2 expression levels. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Trastuzumab Deruxtecan and Chemotherapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 710 participants
- Where
- 86 sitesin 15 countries
- Study dates
- 30 Sep 2025to 23 Mar 2032
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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+).
- Has adequate archived tumor tissue sample available for assessment of HER2 status by central laboratory.
Who cannot join
- 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 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.
Trial locations and contacts
86 sites in 15 countries. Contact the study team or a site near you to ask about taking part.
86 sites in 15 countries
China16 sites, 16 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing
- Recruiting
The First Hospital of Jilin University
Changchun
- Recruiting
West China Second University Hospital, Sichuan University
Chengdu
- Recruiting
Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine
Hangzhou
- Recruiting
Zhejiang Cancer Hospital
Hangzhou
- Recruiting
Cancer Hospital of Shandong First Medical University
Jinan
- Recruiting
Linyi Cancer Hospital
Linyi
- Recruiting
Jiangxi Maternal and Child Health Hospital
Nanchang
- Recruiting
Guangxi Medical University Affiliated Tumor Hospital
Nanning
- Recruiting
Shanghai First Maternity and Infant HospitalShanghai First Maternity and Infant Hospital
Shanghai
- Recruiting
Shanghai Tenth People's Hospital
Shanghai
- Recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan
- Recruiting
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan
- Recruiting
Yantai Yuhuangding Hospital
Yantai
Japan15 sites, 15 recruiting
- Recruiting
Hyogo Cancer Center
Akashi-shi
- Recruiting
National Cancer Center Hospital
Chūōku, 104-0045
- Recruiting
NHO Kyushu Cancer Center
Fukuoka
- Recruiting
Fukushima Medical University Hospital
Fukushima
- Recruiting
Saitama Medical University International Medical Center
Hidaka-shi
- Recruiting
Cancer Institute Hospital of JFCR
Kōtoku
- Recruiting
Kurume University Hospital
Kurume-shi
- Recruiting
Niigata Cancer Center Hospital
Niigata
- Recruiting
Okayama University Hospital
Okayama
- Recruiting
Gunma Prefectural Cancer Center
Ota-shi
- Recruiting
NHO Hokkaido Cancer Center
Sapporo
- Recruiting
Tohoku University Hospital
Sendai
- Recruiting
Keio University Hospital
Shinjuku-ku
- Recruiting
Mie University Hospital
Tsu
- Recruiting
Yamagata University Hospital
Yamagata
United States14 sites, 14 recruiting
- Recruiting
Texas Oncology - Bedford
Bedford, Texas, 76022
- Recruiting
University of Cincinnati Physicians Group, LLC
Cincinnati, Ohio, 45206
- Recruiting
Minnesota Oncology Hematology, P.A.
Coon Rapids, Minnesota, 55433
- Recruiting
Broward Health Medical Center
Fort Lauderdale, Florida, 33316
- Recruiting
Parkview Research Center
Fort Wayne, Indiana, 46845
- Recruiting
Miami Cancer Institute
Miami, Florida, 33176
- Recruiting
Mount Sinai Medical Center
Miami Beach, Florida, 33140
- Recruiting
AdventHealth
Orlando, Florida, 32804
- Recruiting
FirstHealth of the Carolinas, Inc.
Pinehurst, North Carolina, 28374
- Recruiting
Western Pennsylvania Hospital
Pittsburgh, Pennsylvania, 15224
- Recruiting
Texas Oncology San Antonio Medical Center
San Antonio, Texas, 78240
- Recruiting
Trials365 LLC
Shreveport, Louisiana, 71103
- Recruiting
Avera Medical Group Gynecologic Oncology Sioux Falls
Sioux Falls, South Dakota, 57105
- Recruiting
Texas Oncology, P.A. - Tyler
Sioux Falls, South Dakota, 57105
Italy7 sites, 7 recruiting
- Recruiting
Istituto Tumori Giovanni Paolo II IRCCS Ospedale Oncologico Bari
Bari, 70124
- Recruiting
Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpighi IRCCS
Bologna, 40138
- Recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
- Recruiting
Presidio Ospedaliero Alessandro Manzoni di Lecco
Lecco, 23900
- Recruiting
IEO Istituto Europeo di Oncologia
Milan, 20141
- Recruiting
Azienda Ospedaliera Universitaria- Università degli Studi della Campania "Luigi Vanvitelli"
Naples, 80131
- Recruiting
Ospedale Mauriziano Umberto I
Torino, 10128
Argentina6 sites, 6 recruiting
- Recruiting
Hospital Italiano de Buenos Aires
Ciudad Autonoma Buenos Aires, C1199
- Recruiting
Sanatorio Allende Cerro
Córdoba, X5021FPQ
- Recruiting
Centro de Investigaciones Medicas Mar del Plata
Mar del Plata, B7600
- Recruiting
Instituto de Oncologia de Rosario
Rosario, 2000
- Recruiting
Instituto Medico de la Fundacion Estudios Clinicos
Rosario, 2000
- Recruiting
CER San Juan Centro Polivalente de Asistencia e Inv. Clinica
San Juan, 5400
Spain6 sites, 6 recruiting
- Recruiting
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
- Recruiting
Hospital Universitario Virgen de la Arrixaca
El Palmar, 30120
- Recruiting
Hospital Universitario Ramon y Cajal
Madrid, 28034
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
Hospital Universitario La Paz
Madrid, 28046
- Recruiting
Hospital Universitari Son Espases
Palma de Mallorca, 07120
Poland4 sites, 4 recruiting
- Recruiting
Bialostockie Centrum Onkologii im.M.Sklodowskiej-Curie
Bialystok, 15-027
- Recruiting
Szpitale Pomorskie spółka z ograniczoną odpowiedzialnością
Gdynia, 81-519
- Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Poznan, 60-569
- Recruiting
Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawla II w Siedlcach Sp z o o
Siedlce, 08-110
Taiwan4 sites, 4 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung
- Recruiting
National Cheng Kung University Hospital
Tainan
- Recruiting
National Taiwan University Hospital
Taipei
- Recruiting
Taipei Veterans General Hospital
Taipei
Chile3 sites, 3 recruiting
- Recruiting
Biocenter
Concepción, 4070196
- Recruiting
Centro de Estudios Clinicos SAGA
Santiago, 7500653
- Recruiting
Centro de Investigaciones Clinicas de la Universidad Catolica
Santiago, 8330034
France3 sites, 3 recruiting
- Recruiting
Centre Francois Baclesse
Caen, 14076
- Recruiting
Centre Jean Perrin - CLCC
Clermont-Ferrand, 63000
- Recruiting
Institut Claudius Regaud
Toulouse, 31059
South Korea3 sites, 3 recruiting
- Recruiting
Keimyung University Dongsan Hospital
Daegu
- Recruiting
Samsung Medical Center
Seoul
- Recruiting
Seoul National University Hospital
Seoul
Germany2 sites, 2 recruiting
- Recruiting
Klinikum Lippe-Detmold
Detmold, 32756
- Recruiting
Universitatsklinikum Frankfurt
Frankfurt, 60596
About this study
Official title: A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy With or Without Radiotherapy as Adjuvant Treatment for HER2-Expressing (IHC 3+/2+) Endometrial Cancer (DESTINY-Endometrial02/ GOG-3122/ ENGOT-en30/GINECO)
This study is designed to assess efficacy and safety of T-DXd adjuvant therapy, with or without radiotherapy, post-surgery in anticancer treatment naïve (including neoadjuvant therapy) endometrial cancer with various HER2 expression levels.
Read the detailed description
This is a global, multicenter, open-label, phase 3 study to evaluate the efficacy and safety of T-DXd versus SoC chemotherapy with or without radiotherapy as adjuvant treatment in participants with HER2-expressing (IHC 3+/2+) endometrial cancer. Participants will be randomized 1:1 to either T-DXd or SoC chemotherapy. The primary objective will assess disease-free survival as assessed radiographically by BICR or by histopathologic confirmation of disease recurrence per local assessment.
T-DXd (Enhertu®) is a HER2 directed ADC composed of a humanized anti-HER2 IgG1 mAb with the same amino acid sequence as trastuzumab, which includes a plasma-stable, selectively cleavable linker and potent topoisomerase I inhibitor payload (a derivative of exatecan) that leverages the clinically validated DXd ADC technology.
- Conditions
- Endometrial Cancer
- Being tested
- Trastuzumab Deruxtecan, Chemotherapy
- Keywords
- endometrial cancer, T-DXd, HER2, adjuvant treatment
- Medical subject headings
- Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab DeruxtecanDrug
Also called T-DXd, ENHERTU®
T-DXd will be administered at a dose of 5.4 mg/kg IV Q3W.
ChemotherapyDrug
Carboplatin AUC 5 or 6 and paclitaxel will be administered at a dose of 175 mg/m2 Q3W, or carboplatin AUC 5 or 6 and paclitaxel 175 mg/m2 Q3W with or without radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: T-DXd | Experimental | Participants will receive T-DXd 5.4 mg/kg intravenously (IV) once every 3 weeks (Q3W) with or without [optional] radiotherapy Receives: Drug: Trastuzumab Deruxtecan |
| Arm B: Standard of Care Chemotherapy | Active comparator | Participants will receive carboplatin AUC 5 or 6 and paclitaxel 175 mg/m2 Q3W, or AUC 5 or 6 and paclitaxel 175 mg/m2 Q3W with or without [optional] radiotherapy or chemoradiotherapy (EBRT plus cisplatin [as radiosensitizer] 50 mg/m2 Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease-Free Survival (DFS) as Assessed by Blinded Independent Central Review or by Histopathologic Confirmation of Disease Recurrence per Local Assessment
DFS will be assessed radiographically by BICR or by histopathologic confirmation of disease recurrence per local assessment.
Measured: From randomization to the first documented local regional recurrence, distant metastasis, or death due to any cause, whichever occurs first, up to approximately 51 months
Secondary outcomes (1)
Overall Survival
Overall Survival is defined as the time interval from the date of randomization to the date of death due to any cause.
Measured: From randomization to the date of death due to any cause, approximately 63 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start30 Sep 2025
- Primary completion26 Feb 2030 (estimated)
- Study completion23 Mar 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by Daiichi SankyoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 710 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daiichi Sankyo
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022483
- Sponsor's protocol ID
- DS8201-854
- Status last verified
- Oct 2026
- First submitted
- 6 Jun 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Open-label Trial of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy With or Without Radiotherapy as Adjuvant Treatment for HER2-Expressing (IHC 3+/2+) Endometrial Cancer (DESTINY-Endometrial02/ GOG-3122/ ENGOT-en30/GINECO)
- ClinicalTrials.gov ID
- NCT07022483
- Acronym / sponsor ID
- DS8201-854
- Conditions
- Endometrial Cancer
- Keywords
- endometrial cancer, T-DXd, HER2, adjuvant treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 710 participants (estimated)
- Lead sponsor
- Daiichi SankyoIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 26 Feb 2030 (estimated)
- Study completion
- 23 Mar 2032 (estimated)
- First posted
- 15 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess efficacy and safety of T-DXd adjuvant therapy, with or without radiotherapy, post-surgery in anticancer treatment naïve (including neoadjuvant therapy) endometrial cancer with various HER2 expression levels.
Detailed description
This is a global, multicenter, open-label, phase 3 study to evaluate the efficacy and safety of T-DXd versus SoC chemotherapy with or without radiotherapy as adjuvant treatment in participants with HER2-expressing (IHC 3+/2+) endometrial cancer. Participants will be randomized 1:1 to either T-DXd or SoC chemotherapy. The primary objective will assess disease-free survival as assessed radiographically by BICR or by histopathologic confirmation of disease recurrence per local assessment.
T-DXd (Enhertu®) is a HER2 directed ADC composed of a humanized anti-HER2 IgG1 mAb with the same amino acid sequence as trastuzumab, which includes a plasma-stable, selectively cleavable linker and potent topoisomerase I inhibitor payload (a derivative of exatecan) that leverages the clinically validated DXd ADC technology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: T-DXd | Experimental | Drug: Trastuzumab DeruxtecanParticipants will receive T-DXd 5.4 mg/kg intravenously (IV) once every 3 weeks (Q3W) with or without [optional] radiotherapy |
| Arm B: Standard of Care Chemotherapy | Active comparator | Drug: ChemotherapyParticipants will receive carboplatin AUC 5 or 6 and paclitaxel 175 mg/m2 Q3W, or AUC 5 or 6 and paclitaxel 175 mg/m2 Q3W with or without [optional] radiotherapy or chemoradiotherapy (EBRT plus cisplatin [as radiosensitizer] 50 mg/m2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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+).
- Has adequate archived tumor tissue sample available for assessment of HER2 status by central laboratory.
Key exclusion criteria (8 listed)
- 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 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab DeruxtecanAlso: T-DXd, ENHERTU®T-DXd will be administered at a dose of 5.4 mg/kg IV Q3W. | Drug | Arm A: T-DXd |
| ChemotherapyCarboplatin AUC 5 or 6 and paclitaxel will be administered at a dose of 175 mg/m2 Q3W, or carboplatin AUC 5 or 6 and paclitaxel 175 mg/m2 Q3W with or without radiation therapy. | Drug | Arm B: Standard of Care Chemotherapy |
Primary outcome
Disease-Free Survival (DFS) as Assessed by Blinded Independent Central Review or by Histopathologic Confirmation of Disease Recurrence per Local Assessment
Time frame: From randomization to the first documented local regional recurrence, distant metastasis, or death due to any cause, whichever occurs first, up to approximately 51 months
DFS will be assessed radiographically by BICR or by histopathologic confirmation of disease recurrence per local assessment.
1 secondary outcome
Overall Survival
Time frame: From randomization to the date of death due to any cause, approximately 63 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD) on completed studies and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
86 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trastuzumab Deruxtecan and Chemotherapy in people with Endometrial Cancer, run by Daiichi Sankyo at 86 sites in 15 countries.
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 5 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 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 86 sites in China, Japan, United States, Italy, Argentina and 10 more countries. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Contact for Trial Information (908-992-6400, CTRinfo_us@daiichisankyo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease-Free Survival (DFS) as Assessed by Blinded Independent Central Review or by Histopathologic Confirmation of Disease Recurrence per Local Assessment (time frame: From randomization to the first documented local regional recurrence, distant metastasis, or death due to any cause, whichever occurs first, up to approximately 51 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Oct 2026.