CP MGAH22 04 Phase 3 Margetuximab versus Trastuzumab

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.
Cancer (Oncology) - Breast, Cancer (Oncology)
Erin Ellis, MD
Swedish Cancer Institute
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Histologically-proven metastatic or locally-advanced relapsed/refractory HER2+ breast cancer. Tumors may be estrogen receptor (ER)/progesterone receptor (PR) positive or negative.
  • Prior treatment with pertuzumab, trastuzumab, and ado-trastuzumab emtansine in the neoadjuvant, adjuvant, or metastatic setting. Prior radiotherapy and hormonal therapies 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 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
  • Women of childbearing potential must have negative pregnancy test, and agree to use an effective form of contraception for the duration of study treatment and for 120 days after the last dose of study drug

Exclusion Criteria:

  • Known, untreated brain metastasis
  • History of uncontrolled seizures
  • Prior allogeneic bone marrow, stem-cell, or solid organ transplantation
  • History of clinically significant cardiovascular disease
  • Clinically-significant pulmonary compromise, including a requirement for supplemental oxygen use
  • Any condition that would be a contraindication to receiving trastuzumab as described in the approved local label or a condition that would prevent treatment with the protocol specified chemotherapies
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