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SOPHIA: Phase III, 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

Description

The purpose of this study is to determine which treatment regimen is better (margetuximab with standard chemotherapy versus trastuzumab with standard chemotherapy). Survival, tumor size, side effects and quality of life for the two treatments will be compared.

This study will test whether participants with metastatic (having spread to distant organs beyond the breast or close by lymph nodes) or locally-advanced (cancer that hasn’t spread but cannot be cured by surgery) HER2-positive breast cancer that has worsened following standard treatments or lines of therapy will benefit from treatment with standard chemotherapy plus margetuximab compared to standard chemotherapy plus trastuzumab (also called Herceptin®).

Status

Accepting new patients

Primary Study Objective(s)

The primary objective of this study is to evaluate the efficacy, as measured by progression free survival assessed by independent review and overall survival, of margetuximab plus chemotherapy compared with trastuzumab plus chemotherapy in participants with advanced HER2-positive breast cancer who have received at least two prior lines of anti-HER2 directed therapy in the metastatic setting, or in case of having received (neo)adjuvant pertuzumab, at least one prior line of anti-HER2 directed therapy in the metastatic setting, and who have received at least one, and no more than three, lines of therapy overall in the metastatic setting.

Core eligibility

Note: This is only a partial list of eligibility criteria.

Including patients who have:

  • Histologically-proven metastatic or locally-advanced relapsed/refractory HER2-positive breast cancer based on the most recently available tumor biopsy collected from the patient. Tumors may be estrogen receptor/progesterone receptor positive or negative.
  • Had prior treatment with pertuzumab, trastuzumab, and ado-trastuzumab emtansine in the neoadjuvant, adjuvant, or metastatic setting. Prior radiotherapy, hormonal therapies, and other anti-HER2 therapies are allowed.
  • Had prior treatment with at least one, and no more than three, lines of therapy in the metastatic setting. Patients must have progressed on or following, the most recent line of therapy.

Excluding patients who have:

  • Known, untreated brain metastasis. Patients with signs or symptoms of brain metastasis must have a CT or MRI performed within four weeks prior to randomization to specifically exclude the presence of radiographically-detected brain metastases.
  • History of uncontrolled seizures within six months of randomization
  • History of 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 to maintain adequate oxygenation
  • 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 physician's choice of chemotherapy