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Drug Treatment Study for Patients with HER2-Positive Locally Advanced or Metastatic Breast Cancer

Clinical Trial Title: 
A multi-centre, open-label, randomized clinical trial comparing the efficacy and safety of the antibody-drug conjugate SYD985 to physician's choice in patients with HER2-positive unresectable locally advanced or metastatic breast cancer.
Clinical Trial Protocol ID: 
16111104
Clinical Trial Investigator Name: 
Melody A. Cobleigh, MD
Clinical Trial Protocol Description: 

The main purpose of this study is to learn if the effectiveness of SYD985 treatment is superior to physician’s choice treatment in locally advanced or metastatic breast cancer patients and to evaluate the safety and tolerability of SYD985. Eligible patients who participate in this study will be randomly assigned to receive SYD985 or physician's choice treatment. During treatment, patients will visit the clinical site to assess efficacy, quality of life, and safety using standardized criteria.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are a female patient with histologically-confirmed, unresectable locally advanced or metastatic breast cancer.
  • Have HER2-positive tumor status.
  • Have had either progression during or after at least two HER2-targeting treatment regimens for locally advanced or metastatic disease or progression during or after (ado-)trastuzumab emtansine treatment for locally advanced or metastatic disease.

You will be excluded from the study if any of the following criteria apply to you:

  • Have a history of infusion-related reactions and/or hypersensitivity to trastuzumab, (ado-)trastuzumab emtansine.
  • Are currently using or have previously used a prohibited medication, as listed in the study protocol.
  • Have severe, uncontrolled systemic disease at screening.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Breast Cancer
Contact Phone: 
(312) 942-2993
Contact Name: 
Chelsea McPeek, RN