Publication of this data is currently deferred.
Research type
Research Study
Full title
A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in the Treatment of Patients with HER2+ Metastatic Breast Cancer Who Have Received Prior Anti-HER2 Therapies and Require Systemic Treatment (The SOPHIA Study)
IRAS ID
Publication of this data is currently deferred.
Contact name
HIRA SAJJAD
Contact email
Sponsor organisation
MacroGenics Inc
Eudract number
2015-000380-13
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
107768, IND Number
Duration of Study in the UK
Publication of this data is currently deferred.
Research summary
Among women, invasive adenocarcinoma of the breast is the most common non dermatological cancer and the second leading cause of death. Early detection and treatment have reduced the death rate associated with breast cancer, for women diagnosed with metastatic breast cancer. Metastatic breast cancer can be identified either as the initial presentation of the disease, or after recurrence following previous treatment for local disease. \n\nCurrent therapies involve direct targeting of the HER2 oncoprotein, which lengthens survival in patients with HER2+ metastatic breast cancer to the point that now patients with HER2+ disease have a much more favourable prognosis than prior to the introduction of trastuzumab. However, recurrence of disease is common, and additional treatments are needed.\n\nThis is a Phase 3, randomised, open-label, comparator-controlled study comparing margetuximab to trastuzumab, each in combination with chemotherapy, for the treatment of patients with advanced HER2+ breast cancer who have received prior treatment with existing licensed therapies.\n\nUpon meeting all entry criteria, patients enrolled in the study will be randomised 1:1 to receive either margetuximab or trastuzumab to be administered in combination with the chosen chemotherapy. Patients will be treated until disease progression, death, withdrawal of consent, or request by the treating physician to discontinue treatment. Following completion of (or discontinuation from) treatment, patients will be followed for survival.\n\nThis study was developed and is being run by MacroGenics, Inc. Approximately 530 patients will be enrolled in this study over 18 months at up to 200 centres in up to 25 countries.\n
REC name
Publication of this data is currently deferred.
REC reference
Publication of this data is currently deferred.