Summary

for people ages 18 years and up (full criteria)
at UCLA
study started
estimated completion

Description

Summary

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

Official Title

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

Details

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.

Keywords

Breast Cancer Metastatic breast cancer DS 8201a DESTINY - Breast 02 Breast Neoplasms Capecitabine Trastuzumab Lapatinib Camptothecin Ado-trastuzumab emtansine Immunoconjugates Trastuzumab deruxtecan Trastuzumab deruxtecan (DS-8201a) Trastuzumab+capecitabine Lapatinib+capecitabine

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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 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:
  • 4.5 months after the last dose of DS-8201a
  • 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)
  • 7 months after the last dose of trastuzumab/capecitabine
  • Has adequate hematopoietic, renal and hepatic functions

You CAN'T join if...

  • 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

Locations

  • UCLA Hematology Oncology - Main Site accepting new patients
    Los Angeles California 90095 United States
  • Sharp Memorial Hospital accepting new patients
    San Diego California 92123 United States
  • Cancer Research Collaboration accepting new patients
    Santa Ana California 92705 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Daiichi Sankyo, Inc.
ID
NCT03523585
Phase
Phase 3
Study Type
Interventional
Last Updated