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Summary

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

Description

Summary

Some HER-2 breast cancer patients do not respond or build resistance 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

Keywords

Breast Cancer HER-2 positive breast cancer Metastatic or Unresectable Resistant or refractory to T-DM1 Breast Neoplasms Ado-trastuzumab emtansine Camptothecin Immunoconjugates

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 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 not yet accepting patients
    San Francisco, California, 94115, United States
  • Sansum Clinic accepting new patients
    Santa Barbara, California, 93105, United States
  • The Regents of the University of California not yet accepting patients
    Los Angeles, California, 90095, United States
  • Innovative Clinical Research Institute, LLC accepting new patients
    Whittier, California, 90603, United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Daiichi Sankyo, Inc.
ID
NCT03248492
Phase
Phase 2
Study Type
Interventional
Last Updated
March 22, 2018
I’m interested in this study!