Trastuzumab Deruxtecan for Endometrial Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests Trastuzumab Deruxtecan, a targeted cancer therapy, to evaluate its effectiveness for endometrial cancer patients post-surgery. The goal is to determine if it can prevent cancer recurrence, with or without radiotherapy. Participants will receive either this new treatment or standard chemotherapy for comparison. Suitable candidates have recently been diagnosed with endometrial cancer that remains localized or regional and have specific HER2 protein levels in their cancer cells. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking cancer treatment advancements.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Trastuzumab Deruxtecan (T-DXd) is generally well-tolerated by patients with HER2-expressing cancers. One study found that the side effects align with existing knowledge about this treatment. Common side effects include nausea, tiredness, and hair loss, which most patients manage well. However, the treatment has been linked to a risk of interstitial lung disease (ILD), a lung condition that requires monitoring. Despite this risk, the treatment remains approved for other cancers like breast and stomach cancer. Overall, the safety information is reassuring, but discussing any concerns with a doctor is advisable.12345
Why do researchers think this study treatment might be promising for endometrial cancer?
Trastuzumab Deruxtecan is unique because it combines an antibody with a chemotherapy drug, specifically targeting cancer cells in endometrial cancer. This approach allows for direct delivery of the chemotherapy to the cancer cells, potentially reducing harm to healthy cells and leading to fewer side effects compared to standard chemotherapy. Researchers are excited about this treatment because it represents a more precise attack on cancer cells, which could improve effectiveness and patient outcomes compared to traditional options like carboplatin and paclitaxel.
What evidence suggests that Trastuzumab Deruxtecan might be an effective treatment for endometrial cancer?
Research has shown that trastuzumab deruxtecan (T-DXd), which participants in this trial may receive, could effectively treat endometrial cancer with the HER2 protein. This treatment has proven successful in other similar HER2-positive cancers. Many endometrial cancer cases have this protein. Studies have found that T-DXd can help patients live longer and respond well to treatment if their cancer is HER2-positive. The FDA has already approved T-DXd for some gynecologic cancers, suggesting it could be effective. Early research also indicates that T-DXd has manageable side effects, similar to those observed in past studies. Meanwhile, another group in this trial will receive standard care chemotherapy, which includes carboplatin and paclitaxel, with or without optional radiotherapy or chemoradiotherapy.12467
Are You a Good Fit for This Trial?
This trial is for adults over 18 with newly diagnosed FIGO 2023 Stage IIC or III endometrial cancer. Participants must have a confirmed epithelial carcinoma diagnosis, excluding sarcomas but including carcinosarcomas, and show HER2-expression (IHC 3+/2+). Adequate tumor tissue from surgery must be available for testing.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive T-DXd or standard of care chemotherapy with or without optional radiotherapy every 3 weeks
Follow-up
Participants are monitored for disease-free survival and overall survival
What Are the Treatments Tested in This Trial?
Interventions
- Trastuzumab Deruxtecan
Trial Overview
The study tests Trastuzumab Deruxtecan (T-DXd) as an adjuvant therapy post-surgery, with or without radiotherapy, in patients who haven't had previous anticancer treatments. It aims to evaluate the effectiveness and safety compared to standard chemotherapy.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants will receive T-DXd 5.4 mg/kg intravenously (IV) once every 3 weeks (Q3W) with or without \[optional\] radiotherapy
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
Find a Clinic Near You
Who Is Running the Clinical Trial?
Daiichi Sankyo
Lead Sponsor
Hiroyuki Okuzawa
Daiichi Sankyo
Chief Executive Officer
Degree in Social Sciences from Hitotsubashi University
Yuki Abe
Daiichi Sankyo
Chief Medical Officer since 2023
MD
AstraZeneca
Industry Sponsor
Sir Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Dr. Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Pascal Soriot
AstraZeneca
Chief Executive Officer since 2012
Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris
Cristian Massacesi
AstraZeneca
Chief Medical Officer since 2021
MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology
Citations
Exceptional Response to Trastuzumab Deruxtecan (T-DXd ...
While patients diagnosed at an early stage generally have a favourable prognosis, outcomes in advanced settings remain poor. Among histological ...
Successful treatment of gynecologic malignancy with ...
Trastuzumab deruxtecan, which was FDA-approved in 2023, shows particular promise in HER2-expressing gynecologic malignancies. · This report shows ...
DESTINY-Endometrial01 Phase 3 Trial of ENHERTU® ...
HER2 expression (IHC 3+/2+) is associated with aggressive disease and is present in 18% to 56% of endometrial cancers. ... There currently are no ...
Efficacy and Safety of Trastuzumab Deruxtecan in Patients ...
Our study demonstrates durable clinical benefit, meaningful survival outcomes, and safety consistent with the known profile (including ILD) in pretreated ...
5.
onclive.com
onclive.com/view/integrating-t-dxd-in-her2-gynecologic-cancers-impact-on-treatment-decisions-and-sequencingIntegrating T-DXd in HER2+ Gynecologic Cancers
Panelists discuss how the recent accelerated approval of trastuzumab deruxtecan (T-DXd) in HER2-expressing endometrial cancer prompts critical ...
PO007LBA/#1550 Efficacy and safety of trastuzumab ...
Trastuzumab deruxtecan (T-DXd) has demonstrated significant survival benefit for patients with HER2-expressing breast and gastric cancers.
Efficacy and safety of trastuzumab deruxtecan (T-DXd) in ...
Results: At data cutoff (16 Nov 2022; median follow-up, 9.7 mo), 267 pts had been treated (median, 2 prior lines of Tx [range, 0-13]); 75 pts were IHC 3+ and ...
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