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
Clinical Trial Information
Trial Contact: Morales, Leticia; Pelley, Jennifer; Jobson, Gillian S
IRB No: 17.039.04
Protocol Abbrev: SOPHIA
Principal Investigator: Nikita Chandrakant Shah, MD
Sub Investigators: Baidas, Said MD; Cuesta, Ana MD; Rostorfer, Regan MD; Moroose, Rebecca MD
Phase: Drug: Phase III
Age Group: Adult
Secondary Protocol No: CP-MGAH22-04 SOPHIA
Applicable Disease Sites: Breast Cancer
Therapies Involved: Margetuximab plus chemotherapy or Trastuzumab plus chemotherapy
ClinicalTrials.gov ID: NCT02492711
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
• Metastatic or locally-advanced relapsed/refractory HER2+ breast cancer.Tumors may be estrogen receptor (ER)/progesterone receptor (PgR) positive or negative.
• Have received at least 2 prior lines of anti-HER2 directed therapy in the metastatic setting, or in case of having received (neo)adjuvant pertuzumab, at least 1 prior line of anti-HER2 directed therapy in the metastatic setting. In either case, patients must have received prior treatment with pertuzumab, in the (neo)adjuvant or metastatic setting. Prior radiotherapy, hormonal therapies, and other anti-HER2 therapies are allowed.
• Prior treatment with at least one, and no more than three, lines of therapy overall in the metastatic setting. Patients must have progressed on or following, the most recent line of therapy.
• Resolution of all chemotherapy or radiation-related toxicities to ≤ Grade 1
• Life expectancy ≥ 12 weeks
• Acceptable laboratory parameters