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A Study of DS-8201a in Metastatic Breast Cancer Previously Treated With Trastuzumab Emtansine (T-DM1)

Trial Status: Closed to Accrual

Some human epidermal growth factor receptor 2 (HER-2) breast cancer patients do not respond or become resistant to current treatment. DS-8201a is a new experimental product that is a combination of an antibody and a drug. It has not yet been approved for use. DS-8201a may slow down tumor growth. This might improve outcomes for these patients.

Inclusion Criteria

  • Men or women the age of majority in their country
  • Has pathologically documented breast cancer that:
  • is unresectable or metastatic
  • has HER2 positive expression confirmed per protocol
  • Has an adequate tumor sample
  • Has at least one measurable lesion per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
  • Has protocol-defined adequate cardiac, renal and hepatic function
  • Agrees to follow protocol-defined method(s) of contraception

Exclusion Criteria

  • Has a medical history of myocardial infarction, symptomatic congestive heart failure (CHF) (NYHA classes II-IV), unstable angina or serious cardiac arrhythmia
  • Has a corrected QT interval (QTc) prolongation to > 450 millisecond (ms) in males and > 470 ms in females
  • Has a medical history of clinically significant lung disease
  • Is suspected to have certain other protocol-defined diseases based on imaging at screening period
  • Has history of any disease, metastatic condition, drug/medication use or other condition that might, per protocol or in the opinion of the investigator, compromise:
  • safety or well-being of the participant or offspring
  • safety of study staff
  • analysis of results

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: ACTIVE
Contact: Dorreth King-Rucker
Phone: 310-794-5782
San Francisco
UCSF Medical Center-Mount Zion
Status: CLOSED_TO_ACCRUAL
Contact: UCSF Clinical Trials
Phone: 877-827-3222

Hawaii

Honolulu
Kapiolani Medical Center for Women and Children
Status: CLOSED_TO_ACCRUAL
Straub Clinic and Hospital
Status: CLOSED_TO_ACCRUAL

Massachusetts

Boston
Beth Israel Deaconess Medical Center
Status: ACTIVE
Brigham and Women's Hospital
Status: ACTIVE
Dana-Farber Cancer Institute
Status: ACTIVE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: CLOSED_TO_ACCRUAL

New York

New York
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL
Contact: Shanu Modi
Phone: 646-888-4564

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: CLOSED_TO_ACCRUAL

Texas

Dallas
UT Southwestern / Simmons Cancer Center-Dallas
Status: IN_REVIEW
Contact: James Gregory Wright
Phone: 214-648-7020
Houston
M D Anderson Cancer Center
Status: CLOSED_TO_ACCRUAL

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Daiichi Sankyo, Inc.

  • Primary ID DS8201-A-U201
  • Secondary IDs NCI-2017-02077, DESTINY-Breast01, DESTINY-B01, 2016-004986-18, JapicCTI-173693(en)
  • Clinicaltrials.gov ID NCT03248492