Neoadjuvant Breast Cancer Study
EMPOWHER
BC-208
HER2-Positive Early Breast Cancer Study
A Phase 2, randomized, multicenter, open-label study evaluating zanidatamab in combination with chemotherapy in participants with HER2-positive breast cancer.
NCT07102381
What is HER2-Positive, Early-Stage Breast Cancer?
Early HER2-positive breast cancer is a type of early-stage breast cancer in which the cancer cells test positive for the HER2 protein (human epidermal growth factor receptor 2). This protein promotes the growth of cancer cells, and in HER2-positive cases, it is overexpressed, leading to faster-growing, more aggressive tumors.
About the Trial
This study will assess the safety and effectiveness of zanidatamab in combination with standard of care chemotherapy treatments. Participants will be randomized to one of three different treatment arms prior to surgery:
Arm A (50 patients)
zanidatamab + weekly paclitaxel for 6 three-week cycles for a total of 18 weeks
Arm B (50 patients)
zanidatamab + docetaxel + carboplatin for 6 three-week cycles for a total of 18 weeks
Arm C (25 patients)
docetaxel + carboplatin + trastuzumab + pertuzumab for 6 three-week cycles for a total of 18 weeks.
Post-surgery, you will remain in your treatment groups but receive the following treatments based on the outcome of your disease assessed at surgery:
Arms A and B
- Zanidatamab every three weeks for 12 cycles if you have no residual disease after your surgery (a complete pathological response or pCR),
OR
- T-DM1 every three weeks for 14 cycles if you have residual disease after your surgery.
Arm C
- Trastuzumab with or without pertuzumab every three weeks for 12 cycles if you have no residual disease after your surgery (pCR),
OR
- T-DM1 every three weeks for 14 cycles if you have residual disease after your surgery.
Post-surgery, patients in all arms will also receive standard of care endocrine therapy if hormone-receptor positive and standard of care radiation therapy if indicated.
The goal of this study is to learn whether adding zanidatamab to your chemotherapy treatment can improve your health.
About Zanidatamab
Zanidatamab is a type of drug called a biparatopic antibody. Antibodies are proteins that the body makes to attack things that could be harmful, like viruses and bacteria, but also can be used to attack proteins on tumors. A biparatopic antibody can attach to two different regions on the same protein target on a tumor cell. Zanidatamab is an antibody made in a laboratory and is designed to treat patients with tumors that express a protein called HER2 (human epidermal growth factor receptor 2), which can be found on many different types of cancers to include breast cancer. HER2-protein is a protein that can help cancers to grow more quickly. Zanidatamab is designed to treat patients with HER2-positive cancers.
Estimated Enrollment Approximately 125 participants
Inclusion criteria
Participants must:
- Be 18 or older and diagnosed with HER2-positive breast cancer
- Have Stage 2 or Stage 3 breast cancer
For a full list of inclusion criteria, please .
Exclusion criteria
Participants must not have:
- Stage 4 (metastatic) breast cancer
- Bilateral breast cancer
- Uncontrolled hypertension
- Significant symptoms from peripheral neuropathy
For a full list of exclusion criteria, please .
What Will Happen in this Trial
Participants will be assigned to one of three groups to receive zanidatamab plus chemotherapy or standard of care trastuzumab and pertuzumab plus chemotherapy. 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 two weeks for the first four doses (over six weeks) then every three weeks thereafter.
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 "NCT07102381" 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.
To see if you are eligible for this trial, please review the inclusion and exclusion criteria above or consider emailing at clinicaltrialdisclosure@jazzpharma.com to connect with a site near you.
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.