NCT02492711Phase 3Completed

Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of HER2+ Metastatic Breast Cancer

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2021-08-11Actual

Enrollment · participants624Actual

Source updated2025-03-17Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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No recorded changes are available for this view and time period. Our history may be incomplete; this does not establish that the trial stayed unchanged.

Study details

Conditions studied

HER-2 Positive Breast Cancer; Metastatic Neoplasm

Treatments or interventions studied

MargetuximabBiologicalAlso known as MGAH22, Margenza®
TrastuzumabBiologicalAlso known as Herceptin®
Physician's choice of chemotherapy.Drug

Primary outcomes · main study measures

Read the study measures

measure: Progression-free Survival (PFS) as Determined by Independent Radiological Review.; description: PFS is measured from the time of randomization until first documented disease progression or death from any cause, whichever is first.; timeFrame: Tumor assessments are conducted every 6 weeks for the first 24 weeks and then every 24 weeks until progression of cancer, average 5 months.; measure: Overall Survival (OS) Defined as the Number of Days From Randomization to the Date of Death (From Any Cause).; description: Overall survival is the time from randomization until death from any cause; timeFrame: Throughout the study, average 21 months; measure: Number of Patients With Grade 3 or Higher Infusion Related Reactions; description: Incidence of Grade 3 or higher infusion-related reactions for patients receiving 60-minute or 30-minute infusions of margetuximab in Cycle 2 of treatment; timeFrame: 22 days

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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