RecruitingRecruiting
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
NCT07102381 · Jazz Pharmaceuticals
In plain English
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Official title
A Phase 2, Randomized, Multicenter, Open-label Neoadjuvant Study Evaluating Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
About this study
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 criteria
Inclusion Criteria:
1. Has Stage II or III histologically confirmed invasive breast carcinoma.
2. Has histologically confirmed HER2-positive breast cancer
3. Has a known hormone receptor (HR) status of the primary tumor
4. 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.
5. Agrees to undergo a mastectomy or breast conserving surgery (BCS) after neoadjuvant therapy.
6. Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. Adequate organ function
8. Has an LVEF ≥ 50% as determined by either ECHO or MUGA obtained within 4 weeks prior to first dose of study intervention.
9. Adequate contraceptive precautions
Exclusion Criteria:
1. Has Stage IV (metastatic) breast cancer.
2. Has bilateral breast cancer.
3. Has a history of any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the investigator, could affect the participant's involvement in the study.
4. Has uncontrolled hypertension
5. Has significant symptoms from peripheral neuropathy
6. Has an active uncontrolled infection
7. Has a history of life-threatening hypersensitivity to monoclonal antibodies or to recombinant proteins or excipients in the drug formulation of zanidatamab or other study interventions.
8. Known active hepatitis B or C infection.
9. Has another malignancy diagnosed within the last 5 years. Exceptions include previously treated non melanomatous skin cancers, carcinoma in-situ, and melanoma in-situ.
10. Was treated with chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer
11. Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol
12. Receipt of a live vaccine within 4 weeks prior to enrollment
13. Has a known hypersensitivity to any components of the study interventions, including chemotherapy
Study design
Enrollment target: 125 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-09-24
Estimated completion: 2030-08-01
Last updated: 2026-04-29
Interventions
Drug: ZanidatamabDrug: PaclitaxelDrug: DocetaxelDrug: CarboplatinDrug: TrastuzumabDrug: Pertuzumab
Primary outcomes
- • Number of participants with pCR (Up to 8 months)
Sponsor
Jazz Pharmaceuticals · industry
With: Jazz Pharmaceuticals Ireland Limited
Contacts & investigators
ContactClinical Trial Disclosure & Transparency · contact · ClinicalTrialDisclosure@JazzPharma.com · 215-832-3750
All locations (26)
Oncology InstituteRecruiting
Long Beach, California, United States
Rocky Mountain Cancer CentersRecruiting
Denver, Colorado, United States
The Oncology InstituteRecruiting
Lakeland, Florida, United States
Accellacare of McFarlandRecruiting
Ames, Iowa, United States
LSU Health Sciences CenterRecruiting
Shreveport, Louisiana, United States
New England Cancer SpecialistsRecruiting
Scarborough, Maine, United States
Maryland Oncology HematologyRecruiting
Laurel, Maryland, United States
Cancer Partners of NebraskaRecruiting
Lincoln, Nebraska, United States
Nebraska Cancer SpecialistsRecruiting
Omaha, Nebraska, United States
Astera Cancer Care (Formerly Regional Cancer Care Associates)Recruiting
East Brunswick, New Jersey, United States
Medical Oncology Hematology AssociatesRecruiting
Newark, New Jersey, United States
Hematology Oncology Associates of Central New YorkRecruiting
Camillus, New York, United States
Sarah Cannon Research Institute (Nashville)Recruiting
Nashville, Tennessee, United States
Texas Oncology DFWRecruiting
Dallas, Texas, United States
The University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States
Texas Oncology Gulf CoastRecruiting
Houston, Texas, United States
Virginia Cancer SpecialistsRecruiting
Fairfax, Virginia, United States
Virginia Oncology AssociatesRecruiting
Norfolk, Virginia, United States
Shenandoah OncologyRecruiting
Winchester, Virginia, United States
Northwest Medical SpecialtiesRecruiting
Puyallup, Washington, United States
Northwest Cancer SpecialistsRecruiting
Vancouver, Washington, United States
University of WisconsinRecruiting
Madison, Wisconsin, United States
Ospedale San RaffaeleRecruiting
Milan, Lombardy, Italy
Hospital Clínico San CecilioRecruiting
Granada, Andalusia, Spain
Álvaro Cunqueiro HospitalRecruiting
Vigo, Galicia, Spain
Hosp Beata María Ana de JesúsRecruiting
Madrid, Spain