Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion

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:
  • 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

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:
  • safety or well-being of the participant or offspring
  • safety of study staff
  • analysis of results

Locations

  • University of California San Francisco
    San Francisco California 94115 United States
  • Sansum Clinic
    Santa Barbara California 93105 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Daiichi Sankyo, Inc.
ID
NCT03248492
Phase
Phase 2
Study Type
Interventional
Last Updated