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

Status
Closed
Cancer Type
Breast Cancer
Trial Phase
Phase III
Eligibility
, Male and Female
Study Type
Treatment
NCD ID
NCT02492711
Protocol IDs
CP-MGAH22-04 (primary)
Study Sponsor
MacroGenics

Summary

The purpose of this study is to determine whether patients treated with margetuximab plus chemotherapy have longer progression free survival and overall survival than patients treated with trastuzumab plus chemotherapy.

Objectives

  • Progression-free survival as determined by independent radiological review. [ Time Frame: PFS will be evaluated 24 months from the start of the study ] [ Designated as safety issue: No ]
  • Overall survival defined as the number of days from randomization to the date of death (from any cause). [ Time Frame: OS will be evaluated 36 months from the start of the study ] [ Designated as safety issue: No ]
    Overall survival (OS) of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with advanced HER2+ breast cancer.
Same as current
Complete list of historical versions of study NCT02492711 on ClinicalTrials.gov Archive Site
  • To evaluate progression-free survival (PFS), as assessed by study investigators. [ Time Frame: PFS will be evaluated 24 months from the start of the study ] [ Designated as safety issue: No ]
  • To evaluate the objective response rate (ORR) as determined by independent radiological review. [ Time Frame: ORR will be evaluated 36 months from the start of the study ] [ Designated as safety issue: No ]

 

Treatment Sites in Georgia


Northwest Georgia Oncology Centers - Austell
1700 Hospital South Drive
Suite 300
Austell, GA 30106
770-281-5131
www.ngoc.com

Doctors:

Sujatha Hariharan MD
Carlos A. Osmon MD

Northwest Georgia Oncology Centers - Bremen
200 Allen Memorial Drive
Suite 302-B
Bremen, GA 30110
770-281-5131
www.ngoc.com

Doctors:

Bradley J.G. Larson MD

Northwest Georgia Oncology Centers - Carrollton
157 Clinic Avenue
Suite 101
Carrollton, GA 30117
770-281-5131
www.ngoc.com

Doctors:

Bradley J.G. Larson MD
Randall E. Pierce MD

Northwest Georgia Oncology Centers - Cartersville
100 Market Place Boulevard
Suite 200
Cartersville, GA 30121
770-281-5131
www.ngoc.com

Doctors:

Satyen R. Mehta MD
Madhurima Uppalapati MD

Northwest Georgia Oncology Centers - Douglasville
6002 Professional Parkway
Suite 220
Douglasville, GA 30134
770-281-5131
www.ngoc.com

Doctors:

Navin P. Wadehra MD

Northwest Georgia Oncology Centers - Jasper
1020 J.L. White Drive
Suite 160
Jasper, GA 30143
770-281-5131
www.ngoc.com

Doctors:

Curtis R. Miles MD

Northwest Georgia Oncology Centers - Marietta
340 Kennestone Hospital Boulevard
Suite 200
Marietta, GA 30060
770-281-5131
www.ngoc.com

Northwest Georgia Oncology Centers - Paulding
144 Bill Carruth Parkway
Suite 3100
Hiram, GA 30141
770-281-5131
www.ngoc.com

Doctors:

Kathleen A. Long MD
Aron E. Kefela MD

Northwest Georgia Oncology Centers - Villa Rica
705 Dallas Highway
Suite 204
Villa Rica, GA 30180
770-281-5131
www.ngoc.com

Doctors:

Randall E. Pierce MD