Endometrial Cancer study: Trastuzumab Deruxtecan vs Chemotherapy
Official title A Study of Trastuzumab Deruxtecan Versus Standard of Care Chemotherapy for HER2-Expressing (IHC 3+/2+) Endometrial Cancer in Adjuvant Setting
ClinicalTrials.gov ID: NCT07022483
What this study is testing
What is Trastuzumab Deruxtecan?
An investigational once-every-three-weeks intravenous medicine being studied as a potential adjuvant treatment for endometrial cancer. It is designed to target HER2-expressing cancer cells and deliver a chemotherapy agent directly to them.
Also referred to as T-DXd, ENHERTU®.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see how well and how safely trastuzumab deruxtecan works, with or without radiotherapy, after surgery in patients who have not yet received other cancer treatments.
- Who it's for
- Women with endometrial cancer that shows HER2 protein levels of 2+ or 3+ after surgery and who have not had prior cancer therapy.
- What's involved
- Participants will receive either trastuzumab deruxtecan or standard chemotherapy, and may also receive radiotherapy. They will have regular clinic visits and medical tests to monitor treatment effects and side‑effects.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Key Adults ≥18 years at the time the ICF is signed (Please follow local regulatory requirements if the legal age of consent for trial participation...
- Has histologically confirmed diagnosis of epithelial endometrial carcinoma.
- Is newly diagnosed FIGO 2023 Stage IIC (including Stage IICmp53abn) or Stage III Note: FIGO 2023 Stage IIC includes disease with aggressive...
- Has HER2-expression (IHC 3+/2+).
- Has adequate archived tumor tissue sample available for assessment of HER2 status by central laboratory. Key
You likely can't join if
- Has uterine mesenchymal tumor such as an endometrial stromal sarcoma, leiomyosarcoma, or other types of pure sarcomas.
- 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).
- Has a QTcF prolongation to \> 480 msec based on average of the SCR triplicate12-lead ECG.
See the full eligibility criteria
- Key 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...
- Has HER2-expression (IHC 3+/2+).
- Has adequate archived tumor tissue sample available for assessment of HER2 status by central laboratory. Key
- 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).
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Fort Lauderdale, Florida, United States
- Miami, Florida, United States
- Miami Beach, Florida, United States
- Orlando, Florida, United States
- Fort Wayne, Indiana, United States
- Shreveport, Louisiana, United States
- Coon Rapids, Minnesota, United States
- Pinehurst, North Carolina, United States
- Cincinnati, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Sioux Falls, South Dakota, United States
- Bedford, Texas, United States
- San Antonio, Texas, United States
- Ciudad Autonoma Buenos Aires, Argentina
- Córdoba, Argentina
- Mar del Plata, Argentina
- Rosario, Argentina
- San Juan, Argentina
- Concepción, Chile
- Santiago, Chile
+ 56 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Fort Lauderdale, Florida, United States; Miami, Florida, United States; Miami Beach, Florida, United States; Orlando, Florida, United States; Fort Wayne, Indiana, United States; Shreveport, Louisiana, United States and 70 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.