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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 (21) 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
California
Oncology Institute
RECRUITING
Long Beach
Colorado
Rocky Mountain Cancer Centers
RECRUITING
Denver
Florida
The Oncology Institute
RECRUITING
Lakeland
Iowa
Accellacare of McFarland
RECRUITING
Ames
Louisiana
LSU Health Sciences Center
RECRUITING
Shreveport
Maryland
Maryland Oncology Hematology
RECRUITING
Laurel
Maine
New England Cancer Specialists
RECRUITING
Scarborough
Nebraska
Cancer Partners of Nebraska
RECRUITING
Lincoln
Nebraska Cancer Specialists
RECRUITING
Omaha
New Jersey
Astera Cancer Care (Formerly Regional Cancer Care Associates)
RECRUITING
East Brunswick
Medical Oncology Hematology Associates
RECRUITING
Newark
New York
Hematology Oncology Associates of Central New York
RECRUITING
Camillus
Tennessee
Sarah Cannon Research Institute (Nashville)
RECRUITING
Nashville
Texas
Texas Oncology DFW
RECRUITING
Dallas
The University of Texas Southwestern Medical Center
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 Medical Specialties
RECRUITING
Puyallup
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
Related Therapeutic Areas
Sponsors
Collaborators: Jazz Pharmaceuticals Ireland Limited
Leads: Jazz Pharmaceuticals

This content was sourced from clinicaltrials.gov