A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to see if zanidatamab is safe and effective, when combined with chemotherapy, in treating people who has Human Epidermal Growth Factor Receptor 2 (HER2)-positive, early-stage breast cancer
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Has Stage II or III histologically confirmed invasive breast carcinoma.
• Has histologically confirmed HER2-positive breast cancer
• Has a known hormone receptor (HR) status of the primary tumor
• Participants with multifocal or multicentric disease are eligible if the largest tumor (which must be larger than or equal to 2 cm in diameter) is HER2-positive, and the treating physician has determined the participant should be treated as HER2-positive.
• Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ function
• Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 4 weeks prior to first dose of study intervention.
• Adequate contraceptive precautions
Locations
United States
Colorado
Rocky Mountain Cancer Centers
RECRUITING
Denver
Maryland
Maryland Oncology Hematology
RECRUITING
Laurel
New Jersey
Medical Oncology Hematology Associates
RECRUITING
Newark
Tennessee
Sarah Cannon Research Institute (Nashville)
RECRUITING
Nashville
Texas
Texas Oncology DFW
RECRUITING
Dallas
Texas Oncology Gulf Coast
RECRUITING
Houston
Virginia
Virginia Cancer Specialists
RECRUITING
Fairfax
Virginia Oncology Associates
RECRUITING
Norfolk
Shenandoah Oncology
RECRUITING
Winchester
Washington
Northwest Cancer Specialists
RECRUITING
Vancouver
Contact Information
Primary
Clinical Trial Disclosure & Transparency
ClinicalTrialDisclosure@JazzPharma.com
215-832-3750
Time Frame
Start Date:2025-09-24
Estimated Completion Date:2030-08-01
Participants
Target number of participants:125
Treatments
Active_comparator: Zanidatamab with paclitaxel
Zanidatamab in combination with chemotherapy paclitaxel
Active_comparator: Zanidatamab with docetaxel and carboplatin
Zanidatamab in combination with chemotherapy docetaxel and carboplatin
Active_comparator: Trastuzumab and pertuzumab with docetaxel and carboplatin
Trastuzumab and pertuzumab in combination with chemotherapy docetaxel and carboplatin