RecruitingPhase 3NCT07022483

Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer

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)

Sponsor

Daiichi Sankyo

Enrollment

710 participants

Start Date

Sep 30, 2025

Study Type

INTERVENTIONAL

Conditions

Endometrial Cancer

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Phase 3 study is comparing trastuzumab deruxtecan (T-DXd, an antibody-drug conjugate) with standard chemotherapy in women with HER2-expressing advanced endometrial cancer (uterine cancer) that is newly diagnosed at a stage requiring systemic treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with advanced endometrial cancer (FIGO 2023 Stage IIC or Stage III) - Your tumor tests positive for HER2 (IHC 2+ or 3+) - All major histological types are eligible (except pure sarcomas; carcinosarcomas are allowed) **You may NOT be eligible if...** - You have already received systemic treatment for endometrial cancer - Your tumor is HER2-negative - You have significant heart, lung, or liver problems that prevent participation - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTrastuzumab Deruxtecan

T-DXd will be administered at a dose of 5.4 mg/kg IV Q3W.

DRUGChemotherapy

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 followed by chemoradiotherapy.

Locations(40)

Mount Sinai Medical Center

Miami Beach, Florida, United States

Trials365 LLC

Shreveport, Louisiana, United States

Avera Medical Group Gynecologic Oncology Sioux Falls

Sioux Falls, South Dakota, United States

Beijing Cancer Hospital

Beijing, China

The First Hospital of Jilin University

Changchun, China

West China Second University Hospital, Sichuan University

Chengdu, China

Obstetrics and Gynecology Hospital Affiliated to Zhejiang University School of Medicine

Hangzhou, China

Zhejiang Cancer Hospital

Hangzhou, China

Cancer Hospital of Shandong First Medical University

Jinan, China

Linyi Cancer Hospital

Linyi, China

Jiangxi Maternal and Child Health Hospital

Nanchang, China

Guangxi Medical University Affiliated Tumor Hospital

Nanning, China

Shanghai First Maternity and Infant HospitalShanghai First Maternity and Infant Hospital

Shanghai, China

Shanghai Tenth People's Hospital

Shanghai, China

Tianjin Medical University Cancer Institute & Hospital

Tianjin, China

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, China

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

Wuhan, China

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Yantai Yuhuangding Hospital

Yantai, China

Hyogo Cancer Center

Akashi-shi, Japan

NHO Kyushu Cancer Center

Fukuoka, Japan

Fukushima Medical University Hospital

Fukushima, Japan

Saitama Medical University International Medical Center

Hidaka-shi, Japan

Cancer Institute Hospital of JFCR

Kōtoku, Japan

Kurume University Hospital

Kurume-shi, Japan

Niigata Cancer Center Hospital

Niigata, Japan

Okayama University Hospital

Okayama, Japan

Gunma Prefectural Cancer Center

Ota-shi, Japan

NHO Hokkaido Cancer Center

Sapporo, Japan

Tohoku University Hospital

Sendai, Japan

Keio University Hospital

Shinjuku-ku, Japan

Mie University Hospital

Tsu, Japan

Yamagata University Hospital

Yamagata, Japan

Keimyung University Dongsan Hospital

Daegu, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Taichung Veterans General Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

View Full Details on ClinicalTrials.gov

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NCT07022483

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