A Phase 2, randomized, multicenter, open-label neoadjuvant study evaluating zanidatamab in combination with chemotherapy in participants with HER2-positive breast cancer

Condition studied

HER2-positive breast cancer

Investigational medicinal product(s)

Eligibility

Primary endpoint

Local evaluation of pCR rate in the breast and axilla (defined as ypT0/Tis ypN0 per AJCC), as determined by local site pathologist blinded to treatment assignment

Endpoint detail

Pathologic response by RCB classification and score (per NeoSTEEP criteria), Incidence, nature, and severity of TEAEs, Frequency of discontinuations of treatment due to TEAEs, Ovarian function in premenopausal women with ovaries as assessed by clinical measures and laboratory biomarkers, Rate of participants who receive surgery as intended, Rate of BCS in participants without inflammatory breast cancer, EFS, defined as time from randomization to disease progression, disease recurrence (local, regional, distant, or contralateral [invasive]), second primary invasive cancer (non-breast), or death from any cause, Overall Survival, defined as time from randomization to death from any cause, The frequency and severity of symptomatic AEs as assessed by the PRO-CTCAE and EORTC Item Library prior to first dose of study intervention and during the on-treatment period, The percentage of all treated participants, as treated, reporting each level of side-effect bother while on treatment, based on the FACIT-GP5, Serum concentrations of zanidatamab, Frequency, duration, and time of onset of anti-zanidatamab antibodies and neutralizing antibodies, if applicable