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

Recruiting

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Key information

Conditions

HER2-positive Breast Cancer Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ospedale San Raffaele, Milan, Lombardy, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Has newly diagnosed 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 6 weeks prior to randomization.
Adequate contraceptive precautions
Participants with known HIV are eligible unless:

CD4+ T Cell count is less than or equal to 350 microliters (uL)
Detectable viral load, or
Receiving protease inhibitors or cobicistat

Exclusion criteria

Has Stage IV (metastatic) breast cancer.
Has bilateral breast cancer.
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.
Has uncontrolled hypertension
Has significant symptoms from peripheral neuropathy
Has an active uncontrolled infection
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.
Known active hepatitis B or C infection.
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.
Was treated with surgery, chemotherapy, anti-HER2 therapy, radiation therapy, endocrine therapy, or experimental therapy for invasive breast cancer
Is planning to receive concurrent therapy with any other investigational agent or anti-cancer therapy not specified in the protocol
Receipt of a live vaccine within 4 weeks prior to enrollment
Has a known hypersensitivity to any components of the study interventions, including chemotherapy