This study is in progress, not accepting new patients

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

a study on Breast Cancer HER2

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSF
Dates
study started
completion around
Principal Investigator
by sara hurvitz (ucla)

Description

Summary

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.

Official Title

A Phase 2, Multicenter, Open-Label Study of DS-8201a, an Anti-HER2-Antibody Drug Conjugate (ADC) for HER2-Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1 (DESTINY-Breast01)

Keywords

Breast Cancer, HER-2 positive breast cancer, Metastatic or Unresectable, Resistant or refractory to T-DM1, DESTINY - Breast 01, Trastuzumab deruxtecan, T-DXd, Breast Neoplasms

Eligibility

You can join if…

Open to people ages 18 years and up

  • Men or women the age of majority in their country
  • Has pathologically documented breast cancer that:
    1. is unresectable or metastatic
    2. 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

You CAN'T join if...

  • 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:
    1. safety or well-being of the participant or offspring
    2. safety of study staff
    3. analysis of results

Locations

  • The Regents of the University of California
    Los Angeles California 90095 United States
  • University of California San Francisco
    San Francisco California 94115 United States
  • Sharp Clinical Oncology Research
    San Diego California 92123 United States
  • Innovative Clinical Research Institute, LLC
    Whittier California 90603 United States

Lead Scientist at University of California Health

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Daiichi Sankyo
ID
NCT03248492
Phase
Phase 2 research study
Study Type
Interventional
Participants
About 253 people participating
Last Updated