DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03]



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/5/2019
Start Date:July 20, 2018
End Date:February 2022
Contact:(For Sites in Asia Only) Daiichi Sankyo Contact for Clinical Trial Information
Email:dsclinicaltrial@daiichisankyo.co.jp
Phone:+81-3-6225-1111(M-F 9-5 JST)

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A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201a (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

This study is designed to compare the anti-tumor activity as well as the safety and efficacy
of DS-8201a versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer
subjects previously treated with trastuzumab and taxane.


Inclusion Criteria:

- Is the age of majority in their country

- Has pathologically documented breast cancer that:

1. is unresectable or metastatic

2. has confirmed HER2-positive expression as determined according to American
Society of Clinical Oncology - College of American Pathologists guidelines
evaluated at a central laboratory

3. was previously treated with trastuzumab and taxane in the advanced/metastatic
setting or progressed within 6 months after neoadjuvant or adjuvant treatment
involving a regimen including trastuzumab and taxane

- Has documented radiologic progression (during or after most recent treatment or within
6 months after completing adjuvant therapy)

- Is HER2 positive as confirmed by central laboratory assessment of most recent tumor
tissue sample available. If archived tissue is not available, agrees to provide a
fresh biopsy.

- If of reproductive/childbearing potential, agrees to use a highly effective form of
contraception or avoid intercourse during and upon completion of the study for at
least 4.5 months after the last dose of DS-8201a or 7 months after the last dose of
T-DM1

- Has adequate renal and hepatic function

Exclusion Criteria:

- Has previously been treated with an anti-HER2 antibody drug conjugate (ADC)

- Has uncontrolled or significant cardiovascular disease

- Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that
required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis
cannot be ruled out by imaging at screening

- Has spinal cord compression or clinically active central nervous system (CNS)
metastases, defined as untreated and symptomatic, or requiring therapy with
corticosteroids or anticonvulsants to control associated symptoms.

1. Participants with clinically inactive brain metastases may be included in the
study.

2. Participants with treated brain metastases that are no longer symptomatic and who
require no treatment with corticosteroids or anticonvulsants may be included in
the study if they have recovered from the acute toxic effect of radiotherapy. A
minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy
and study enrollment.
We found this trial at
20
sites
300 Halket St.
Pittsburgh, Pennsylvania 15213
1-866-MyMagee (696-2433)
Phone: 412-641-6500
Magee-Womens Hospital of UPMC Magee-Womens Hospital of UPMC is a world-class center for both women's...
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Atlanta, Georgia 30318
Phone: 678-298-3241
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Auburn, Washington 98001
Phone: 253-209-8972
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Auburn, WA
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Phone: 410-951-7908
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Calgary, Alberta
Phone: 403-521-3492
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Calgary,
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Chattanooga, Tennessee 37404
Phone: 423-698-1844
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Cleveland, Ohio 44106
Phone: 216-844-8571
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Cleveland, OH
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East Setauket, New York 11733
Phone: 631-675-5143
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East Setauket, NY
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Houston, Texas 77090
Phone: 877-870-2640
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Houston, TX
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2316 E Meyer Blvd
Kansas City, Missouri 64132
(816) 276-4000
Phone: 816-276-4700
Research Medical Center Research Medical Center offers hospital and health clinic services across three Kansas...
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1382 East Stroop Road
Kettering, Ohio 45409
Phone: 937-771-2287
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Kettering, OH
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Los Angeles, California 90095
Phone: 626-396-2989
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Los Angeles, CA
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Louisville, Kentucky 40207
Phone: 502-899-3366
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Louisville, KY
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Monterey, California 93940
Phone: 831-375-4105
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Monterey, CA
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Nashville, Tennessee 37205
Phone: 615-524-4016
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Nashville, TN
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Ogden, Utah 84403
Phone: 801-387-7166
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Ogden, UT
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Phone: 412-359-8162
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Santa Ana, California 92705
Phone: 562-981-6101
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Santa Ana, CA
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Washington, District of Columbia 20010
Phone: 202-877-9386
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Whittier, California 90603
Phone: 562-693-4477
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