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



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/29/2019
Start Date:November 30, 2017
End Date:May 2021
Contact:Evelyn van den Tweel, PhD
Email:clinicaltrials@synthon.com
Phone:+31 24 372 7700

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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

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

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.

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.
We found this trial at
22
sites
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
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6701 N Charles St
Baltimore, Maryland 21204
(443) 849-2000
Greater Baltimore Medical Center The 255-bed medical center (acute and sub-acute care) is located on...
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121 Boulevard de Waterloo
Brussel, 1000
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Brussel,
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Dallas, TX
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Denton, Texas 76210
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2799 W Grand Blvd
Detroit, Michigan 48202
(313) 916-2600
Henry Ford Hospital Founded in 1915 by auto pioneer Henry Ford and now one of...
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8503 Arlington Blvd., Ste. 400
Fairfax, Virginia 22031
(703) 280-5390
Virginia Cancer Specialists, PC Now the world's most advanced cancer treatment capabilities can be found...
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Houston, Texas 77024
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Mobile, Alabama 36608
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5900 Lake Wright Dr
Norfolk, Virginia 23502
(757) 466-8683
Virginia Oncology Associates Virginia Oncology Associates is an oncology and hematology practice of physicians, specializing...
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Norfolk, VA
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Pensacola, Florida 32503
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Pinehurst, North Carolina 28374
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Pittsburgh, Pennsylvania 15213
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Portland, Oregon 97213
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San Antonio, Texas 78217
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San Diego, California 92093
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Toledo, Ohio 43623
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Tucson, Arizona 85712
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Tyler, Texas 75702
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818 N. Emporia, #403
Wichita, Kansas 67214
(316) 262-4467
Cancer Center of Kansas The physicians of Cancer Center are hematologists and oncologists. The staff...
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