EMPOWHER-303 Study
A Phase 3, randomized, open-label, controlled study comparing the efficacy and safety of zanidatamab to trastuzumab, each in treatment of participants with metastatic HER2-positive breast cancer who have progressed on, or are intolerant to, previous trastuzumab deruxtecan treatment (T-DXd).
What is HER2-Positive Metastatic Breast Cancer (mBC)?
Metastatic Breast Cancer is a type of cancer that affects the breast and has spread (metastasized) to other organs in the body. HER2 (Human Epidermal Growth Factor Receptor 2) is a cell surface receptor on breast cancer cells. Overexpression of HER2 or other abnormalities may signal breast cancer cells to keep growing and certain HER2-Directed treatments are effective against this type of mBC.
About the Trial
This study will assess safety and efficacy of zanidatamab compared to trastuzumab, both in combination with doctor’s choice of chemotherapy. The goal of this study is to learn whether zanidatamab is safe and works better when compared to trastuzumab in treating HER2-positive metastatic breast cancer patients who have progressed on, or are intolerant to, previous trastuzumab deruxtecan treatment (T-DXd). This study will evaluate how long you will remain disease free and continue in the study after you have completed the study treatment to assess long term effect of this treatment on your survival.
Zanidatamab is a HER2-targeted bispecific antibody that can simultaneously bind two non-overlapping epitopes (or antigens) of HER2. This design and increased binding is believed to result in multiple mechanisms of action, including dual HER2 signal blockade, removal of HER2 protein from the cell surface, and immune-mediated cytotoxicity. It is also thought that bispecific antibodies may help overcome challenges associated with co-administration of drugs, such as dose-limiting toxicities and drug-drug interactions, by circumventing the need to deliver two separate therapies.
Phase
3
Estimated Enrollment
Approximately 550 participants
(225 participants in each treatment arm)
Key Eligibility Criteria
Inclusion criteria
Participants must
- Be 18 or older and diagnosed with HER2-positive breast cancer
- Have HER2-positive breast cancer that is unresectable or metastatic
- Have HER2-positive breast cancer that progressed on or is intolerant to be treated with fam-trastuzumab deruxtecan-nxki (trastuzumab deruxtecan).
Exclusion criteria
Participants must not
- Be pregnant, breastfeeding, or planning to become pregnant
- Have uncontrolled or significant cardiovascular disease
- Have active CNS metastasis
- Have uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
Check Your Eligibility
We’ll check to see if you may qualify for this clinical trial by asking you some questions.
What Will Happen in this Trial
Participants will be assigned to one of two groups to receive either zanidatamab or trastuzumab, plus their doctor’s choice of chemotherapy (combination treatment) with both treatment arms. Both the participant and study doctor will know which treatment the participant will be receiving. The study medicine, zanidatamab, will be administered through the vein via IV infusion every 3 weeks.
Participants in the study will be monitored closely on a regular basis to avoid any serious risk. Enrolled participants will also receive frequent physical examinations and laboratory testing as part of study participation that may not be normally part of standard of care.
Study Locations
For site location, please contact ClinicalTrialDisclosure@jazzpharma.com or visit clinicaltrials.gov (and search "NCT06435429" or click here).
Trial sites listed below are available from clinicaltrials.gov. We do not endorse any specific trial sites.
Frequently Asked Questions (FAQs)
Clinical trials are carefully controlled scientific studies that evaluate how well investigational or modified medicines may treat or prevent diseases in people. A clinical trial follows a protocol that has been approved by regulatory agencies and IRBs/ECs.
Qualified participants will receive payment for their trial-related time and travel.
You can check if you are potentially eligible for this trial by completing a short questionnaire. You can find the questionnaire on this website by clicking the “Get Started” button.
Participation is voluntary. You have the right to end your participation in the clinical trial at any time for any reason, or no reason at all. The clinical trial doctor or sponsor also has the right to discontinue a participant at any time for that person’s safety or if the participant no longer meets the trial requirements. You should contact the study team with any questions.