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: Active

Description

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.

Eligibility Criteria

Inclusion Criteria

  • Is the age of majority in their country
  • Has pathologically documented breast cancer that:
  • is unresectable or metastatic
  • has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
  • 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.
  • Participants with clinically inactive brain metastases may be included in the study.
  • 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.

Locations & Contacts

California

Los Angeles
UCLA / Jonsson Comprehensive Cancer Center
Status: Active
Contact: Sa-Heim Davis
Phone: 310-825-4494
Email: sjdavis@mednet.ucla.edu
San Francisco
UCSF Medical Center-Mount Zion
Status: Approved
Contact: UCSF Clinical Trials
Phone: 877-827-3222
Email: cancertrials@ucsf.edu

Massachusetts

Boston
Brigham and Women's Hospital
Status: Temporarily closed to accrual
Name Not Available
Dana-Farber Cancer Institute
Status: Temporarily closed to accrual
Name Not Available

Ohio

Cleveland
Case Comprehensive Cancer Center
Status: Active
Name Not Available
Columbus
Ohio State University Comprehensive Cancer Center
Status: Active
Name Not Available

Pennsylvania

Pittsburgh
University of Pittsburgh Cancer Institute (UPCI)
Status: Active
Name Not Available

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: Active
Name Not Available

Texas

Houston
M D Anderson Cancer Center
Status: Active
Name Not Available
San Antonio
Cancer Therapy and Research Center at The UT Health Science Center at San Antonio
Status: Active
Contact: Virginia G. Kaklamani
Phone: 210-450-3838
Email: kaklamani@uthscsa.edu

Trial Phase & Type

Trial Phase

Phase III

Trial Type

Treatment

Lead Organization

Lead Organization
Daiichi Sankyo, Inc.

Trial IDs

Primary ID DS8201-A-U302
Secondary IDs NCI-2018-02956, 183976, 2018-000222-61, DESTINY-B03
Clinicaltrials.gov ID NCT03529110