SYD985 vs. Physician's Choice in Participants With HER2-positive Locally Advanced or Metastatic Breast Cancer

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to demonstrate that SYD985 [(vic-)trastuzumab duocarmazine] is superior to physician's choice in prolonging progression free survival.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Byondis B.V.; Synthon Biopharmaceuticals BV
• Treatments: Capecitabine; Lapatinib; Trastuzumab; Vinorelbine

Criteria

Main Inclusion Criteria:

• Female patients with histologically-confirmed, unresectable locally advanced or metastatic breast cancer;

• Patients should 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;

• HER2-positive tumor status;

• Patients must have measurable or non-measurable disease that is evaluable per RECIST 1.1;

• Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2;

• Estimated life expectancy > 12 weeks at randomization;

• Adequate organ function and blood cell counts.

Main Exclusion Criteria:

• Current or previous use of a prohibited medication as listed in the protocol;

• History of infusion-related reactions and/or hypersensitivity to trastuzumab, (ado-)trastuzumab emtansine;

• History of keratitis;

• Severe, uncontrolled systemic disease at screening;

• Left Ventricular Ejection Fraction (LVEF) < 50%, or a history of clinically significant decrease in LVEF during previous treatment with trastuzumab or (ado-)trastuzumab emtansine;

• Cardiac troponin value above the Upper Limit of Normal (ULN);

• History of clinically significant cardiovascular disease;

• Untreated brain metastases, symptomatic brain metastases, brain metastases requiring steroids to manage symptoms, or treatment for brain metastases within 8 weeks prior to randomization;

• History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.