DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]



Status:Recruiting
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/6/2019
Start Date:August 1, 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, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1

This study will compare DS 8201a to standard treatment.

Participants must have HER2 breast cancer that has been treated before.

Their cancer:

- cannot be removed by an operation

- has spread to other parts of the body

The study is designed to compare DS 8201a versus standard of care (investigator's choice) in
subjects with unresectable and/or metastatic breast cancer previously treated with T-DM1.

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 ado-trastuzumab emtansine (T-DM1)

- 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.

- Male and female participants of reproductive/childbearing potential must agree to use
a highly effective form of contraception or avoid intercourse during and upon
completion of the study and for at least:

1. 4.5 months after the last dose of DS-8201a

2. 6 months after the last dose of lapatinib/capecitabine for female participants (3
months for male participants)

3. 7 months after the last dose of trastuzumab/capecitabine

- Has adequate hematopoietic, renal and hepatic functions

Exclusion Criteria:

- Has previously participated in an antibody drug conjugate study sponsored by Daiichi
Sankyo

- Has had prior treatment with capecitabine

- Has uncontrolled or significant cardiovascular disease

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

- Has active central nervous system (CNS) metastases
We found this trial at
21
sites
450 Brookline Ave
Boston, Massachusetts 2215
617-632-3000
Phone: 617-632-3339
Dana-Farber Cancer Institute Since it’s founding in 1947, Dana-Farber has been committed to providing adults...
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Atlanta, Georgia 30318
Phone: 717-724-6780
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345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Phone: 410-783-5858
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
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Baltimore, Maryland 20742
(301) 405-1000
Phone: 410-328-3546
University of Maryland As a globally-connected university offering a world-class education, the University of Maryland...
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Chandler, Arizona 85224
Phone: 480-314-6694
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East Setauket, New York 11733
Phone: 631-675-5111
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Frankston, Victoria
Phone: +61 397815422
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Joplin, Missouri 64804
Phone: 417-347-4000
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4321 Washington Street #4000
Kansas City, Missouri 64111
(816) 932-3300
Phone: 816-932-3300
Saint Luke's Cancer Institute Hope is an important part of the arsenal that helps patients...
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1382 East Stroop Road
Kettering, Ohio 45409
Phone: 937-771-2422
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Los Angeles, California 90095
Phone: 310-794-6500
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Louisville, Kentucky 40207
Phone: 502-899-3366
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Monterey, California 93940
Phone: 831-375-4105
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Munster, Indiana 46321
Phone: 219-924-8178
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Ogden, Utah 84403
Phone: 801-387-7166
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Ogden, Utah 84405
Phone: 801-689-3909
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Phone: 412-359-6147
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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Tacoma, Washington 98405
Phone: 253-403-3321
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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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