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A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in he Treatment of Patients with HER2+ Metastatic Breast Cancer Who Have Received Two Prior Anti-Her+ Therapies and Require Systemic Treatment
Overall Recruitment Status: Active, enrollment completed
 
Official Title
A Phase 3, Randomized Study of Margetuximab Plus Chemotherapy vs Trastuzumab Plus Chemotherapy in he Treatment of Patients with HER2+ Metastatic Breast Cancer Who Have Received Two Prior Anti-Her+ Therapies and Require Systemic Treatment
 
Region Sponsors
Hawaii
MacroGenics, Inc.
 
Acronym KP IRB No.
SOPHIA Pro00006067
 
Study Type Phase
Clinical Trial Phase III
 
Study Population Description
 
Purpose
To determine whether patients treated with margetuximab plus chemotherapy have longer progression free survival and over survival than patients treated with trastuzumab plus chemotherapy.
 
Detailed Description
An evaluation o efficacy, as measured by progression-free survival (PFS) assessed by independent and overall survival (OS), of margetuximab plus chemotherapy compared to trastuzumab plus chemotherapy in patients with advanced HER2+ breast cancer who have received prior treatment with trastzumab, pertuzumab, and ado-trastuzumab emtansine in the neoadjuvant, or metastatic setting, and who have received at least one, and no more than two, lines of therapy in the metastatic setting, and who have received at least one, and no more than two, lines of therapy in the metastatic setting.
 
Gender Age Limit
Male & Female
 
Inclusion Criteria
  • Histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast cancer. Tumors may be estrogen receptor/progesterone receptor positivie or negative
  • Prior treatment with pertuzumab, trastuzumab, and ado-trastuzumab emtansine in the neoadjuvant, adjuvant, or metastic setting. Prior radiotherapy and hormonal therapy are allowed
  • Prior treatment for at least one, and no more than two, lines of therapy in the metastatic setting. Patients must have progressed on o following the most recent line of therapy
  • Resolution of all chemotherapy or radiaton-related toxicities to <= Grade 1
  • Life expectancy >= 12 weeks
 
Exclusion Criteria
  • Known, untreated brain metastasis
  • History of uncontrolled seizures
  • Prior allogenic bone marrow, stem-cell, or solid organ transplantation
  • History of clinically signifcant cardiovascular disease
  • Clinically significnt pulmonary compromise, incluing a requirement for supplemental oxygen use

 
Keywords and/or Specific Medical Conditions
  • Oncology (Adult)
 
KP Clinical Facility
  • Moanalua Medical Center and Clinic
 
Clinical Area
  • Oncology (Adult)


Principal Investigator:
Jennifer Carney, MD
Contact Information:
- Shelley Clark, RN
-Moanalua Medical Center and Clinic


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