Recruiting
A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Cancer
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
ClinicalTrials.gov IDNCT07102381
PhasePHASE2
Enrollment125
SponsorJazz Pharmaceuticals
Age18 Years
SexALL
Conditions studied
HER2-positive Breast Cancer, 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
Interventions
- Drug: Zanidatamab — Administered intravenously (IV)
- Drug: Paclitaxel — Administered intravenously (IV)
- Drug: Docetaxel — Administered intravenously (IV)
- Drug: Carboplatin — Administered intravenously (IV)
- Drug: Trastuzumab — Administered intravenously (IV)
- Drug: Pertuzumab — Administered intravenously (IV)
Primary outcomes
- Number of participants with pCR (Up to 8 months)
Eligibility information
Inclusion Criteria:
1. Has newly diagnosed 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 6 weeks prior to randomization.
9. Adequate contraceptive precautions
10. Participants with known HIV are eligible unless:
1. CD4+ T Cell count is less than or equal to 350 microliters (uL)
2. Detectable viral load, or
3. Receiving protease inhibitors or cobicistat
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. Participants with prior ipsilateral ductal carcinoma in situ (DCIS) or invasive breast cancer are not eligible.
10. Was treated with surgery, 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 locations
- Oncology Institute, Long Beach, California 90805 United States
- Cancer & Blood Research Center, Los Alamitos, California 90720 United States
- Rocky Mountain Cancer Centers, Denver, Colorado 80218 United States
- Holy Cross Hospital, Fort Lauderdale, Florida 33308 United States
- The Oncology Institute, Lakeland, Florida 33812 United States
- Accellacare of McFarland, Ames, Iowa 50010 United States
- LSU Health Sciences Center, Shreveport, Louisiana 71103 United States
- New England Cancer Specialists, Scarborough, Maine 04074 United States
- Maryland Oncology Hematology, Laurel, Maryland 20707 United States
- Henry Ford Hospital, Detroit, Michigan 48202 United States
Showing 10 of 35 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.