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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Number of participants with pCR — Up to 8 months Pathologic complete response (pCR) is defined as lacking all signs of cancer in the tissue samples removed in the breast or axilla (armpit) during surgery or biopsy after study treatment
Trial sites (35)
Facility
City
Region
Status
Oncology Institute
Long Beach
California
Recruiting
Cancer & Blood Research Center
Los Alamitos
California
Recruiting
Rocky Mountain Cancer Centers
Denver
Colorado
Recruiting
Holy Cross Hospital
Fort Lauderdale
Florida
Recruiting
The Oncology Institute
Lakeland
Florida
Recruiting
Accellacare of McFarland
Ames
Iowa
Recruiting
LSU Health Sciences Center
Shreveport
Louisiana
Recruiting
New England Cancer Specialists
Scarborough
Maine
Recruiting
Maryland Oncology Hematology
Laurel
Maryland
Recruiting
Henry Ford Hospital
Detroit
Michigan
Recruiting
Cancer Partners of Nebraska
Lincoln
Nebraska
Recruiting
Nebraska Cancer Specialists
Omaha
Nebraska
Recruiting
Astera Cancer Care (Formerly Regional Cancer Care Associates)
East Brunswick
New Jersey
Recruiting
Medical Oncology Hematology Associates
Newark
New Jersey
Recruiting
The University of New Mexico
Albuquerque
New Mexico
Recruiting
Hematology Oncology Associates of Central New York
Camillus
New York
Recruiting
Memorial Sloan Kettering Cancer Center
New York
New York
Recruiting
Levine Cancer
Charlotte
North Carolina
Recruiting
Sarah Cannon Research Institute (Nashville)
Nashville
Tennessee
Recruiting
Texas Oncology DFW
Dallas
Texas
Recruiting
The University of Texas Southwestern Medical Center
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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