MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in HER2-Positive Locally Advanced/Metastatic Breast Cancer Patients

Official Title

A Randomized, Multicentre, Open Label Study of MM-302 Plus Trastuzumab vs. Chemotherapy of Physician's Choice Plus Trastuzumab in Anthracycline Naive Patients With Locally Advanced/Metastatic HER2-Positive Breast Cancer

Summary:

This study is an open label, randomized, multicentre trial of MM-302 plus trastuzumab. The trial is designed to demonstrate whether MM-302 plus trastuzumab is more effective than the chemotherapy of physician's choice (CPC) plus trastuzumab in locally advanced/metastatic HER2-positive breast cancer patients. Patients may not have been previously treated with an anthracycline in any setting. Patients must have received prior treatment with trastuzumab in any setting, have either progressed or are intolerant to ado-trastuzumab emtansine in the metastatic or locally advanced setting, have either progressed or are intolerant to pertuzumab in the metastatic or locally advanced setting or had disease recurrence within 12 months of pertuzumab treatment in the neoadjuvant or adjuvant setting.

Trial Description

Primary Outcome:

  • Independently assessed progression-free survival according to modified Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
Secondary Outcome:
  • Locally assessed progression-free survival according to Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
  • Overall Survival
  • Time to Treatment Failure
  • Objective Response Rate based on independent and investigator review of tumour assessments
  • Duration of Response (DoR) based on independent and investigator review of tumour assessments
  • Safety
  • Pharmacokinetic exposure of MM-302

View this trial on ClinicalTrials.gov

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Resources

Canadian Cancer Society

These resources are provided in partnership with the Canadian Cancer Society