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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
125
Administered intravenously (IV)
Administered intravenously (IV)
Administered intravenously (IV)
Oncology Institute
Long Beach, California, United States
Number of participants with pCR
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
Time frame: Up to 8 months
Number of participants with Pathologic response by Residual Cancer Burden (RCB) classification
Time frame: Up to 8 months
Number of Participants with Treatment-emergent Adverse Events (TEAEs)
Time frame: Up to 23 months
Number of Participants Discontinuing Study Treatment Due to TEAEs
Time frame: Up to 23 months
Number of participants that completed breast conservation surgery (BCS)
Time frame: Up to 8 months
Event Free Survival (EFS)
EFS is defined as the time (in months) from randomization to disease progression, disease recurrence, or death from any cause
Time frame: Up to 46 months
Overall Survival (OS)
OS is defined as the time in months from randomization to the date of death due to any cause.
Time frame: Up to 46 months
Number of participants reporting Symptomatic Adverse Events based on Patient-reported Outcome-Common Terminology Criteria for AEs (PRO-CTCAE)
Symptomatic AEs assessed by the PRO-CTCAE are analyzed at the item level with symptom severity, frequency, and interference scored from 0 to 4 and presence/absence scored 0 to 1, and higher scores reflect worse symptoms.
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Administered intravenously (IV)
Administered intravenously (IV)
Administered intravenously (IV)
Rocky Mountain Cancer Centers
Denver, Colorado, United States
RECRUITINGThe Oncology Institute
Lakeland, Florida, United States
RECRUITINGAccellacare of McFarland
Ames, Iowa, United States
RECRUITINGLSU Health Sciences Center
Shreveport, Louisiana, United States
RECRUITINGNew England Cancer Specialists
Scarborough, Maine, United States
RECRUITINGMaryland Oncology Hematology
Laurel, Maryland, United States
RECRUITINGCancer Partners of Nebraska
Lincoln, Nebraska, United States
RECRUITINGNebraska Cancer Specialists
Omaha, Nebraska, United States
RECRUITINGAstera Cancer Care (Formerly Regional Cancer Care Associates)
East Brunswick, New Jersey, United States
RECRUITING...and 10 more locations
Time frame: Up to 23 months
Number of participants reporting Symptomatic Adverse Events based on European Organisation for Research and Treatment of Cancer (EORTC) Item Library
Symptomatic AEs assessed by the EORTC Item Library Forms are analyzed at the item level with scores ranging from 1 to 4, where a 4 indicates more severe symptoms.
Time frame: Up to 23 months
Percentage of all treated participants reporting overall side-effect bother on the Functional Assessment of Chronic Illness Therapy General Physical Item 5 (FACIT-GP5)
The Functional Assessment of Chronic Illness Therapy (FACIT) GP5 Item score ranges from 0 (Not at all) to 4 (Very Much), where higher scores reflect greater bother from treatment side effects.
Time frame: Up to 23 months
Serum Concentrations of Zanidatamab
Time frame: Up to 18 months
Number of Participants Positive for Anti-drug Antibodies to Zanidatamab
Time frame: Up to 18 months