Last updated on August 2019

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


Brief description of study

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

Detailed Study Description

This study is designed as a randomized, active-controlled, superiority study in patients with unresectable locally advanced or metastatic HER2-positive breast cancer. The 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.

Eligible patients will be randomly assigned (2:1) to receive SYD985 or physician's choice treatment until disease progression, unacceptable toxicity or study termination by the Sponsor. During treatment, patients will have to visit the clinical site to assess efficacy, quality of life (QoL), and safety using standardized criteria.

Clinical Study Identifier: NCT03262935

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Southern Cancer Center

Mobile, AL United States
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Moores UCSD Cancer Center

San Diego, CA United States
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Woodlands Medical Specialists

Pensacola, FL United States
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Cancer Center of Kansas

Wichita, KS United States
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Henry Ford Hospital

Detroit, MI United States
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Northwest Cancer Specialists

Portland, OR United States
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Magee-Womens Hospital of UPMS

Pittsburgh, PA United States
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Baylor College of Medicine

Houston, TX United States
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Texas Oncology-Tyler

Tyler, TX United States
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UZ Gent

Gent, Belgium
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AZ Groeninge

Kortrijk, Belgium
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CHU Liege

Liege, Belgium
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S nderborg sygehus

Sønderborg, Denmark
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Casa Sollievo Della Sofferenza

San Giovanni Rotondo, Italy
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VU Medical Center

Amsterdam, Netherlands
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SCRI UK

London, United Kingdom
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The Christie NHS Foundation

Manchester, United Kingdom
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S nderborg sygehus

Sønderborg, Denmark
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S nderborg sygehus

Sønderborg, Denmark
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S nderborg sygehus

Sønderborg, Denmark
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S nderborg sygehus

Sønderborg, Denmark
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S nderborg sygehus

Sønderborg, Denmark
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S nderborg sygehus

Sønderborg, Denmark
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S nderborg sygehus

Sønderborg, Denmark
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