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

Daiichi Sankyo logo

Daiichi Sankyo

Status and phase

Active, not recruiting
Phase 2

Conditions

Breast Cancer

Treatments

Drug: DS-8201a

Study type

Interventional

Funder types

Industry

Identifiers

NCT03248492
DS8201-A-U201
DESTINY-Breast01 (Other Identifier)
JapicCTI-173693(en) (Registry Identifier)
2016-004986-18 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

253 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

253 participants in 4 patient groups

DS-8201a Low Dose
Experimental group
Description:
T-DM1 resistant/refractory (R/R) patients in the low dose treatment group
Treatment:
Drug: DS-8201a
DS-8201a Medium Dose
Experimental group
Description:
T-DM1 resistant/refractory (R/R) patients in the medium dose treatment group
Treatment:
Drug: DS-8201a
DS-8201a High Dose
Experimental group
Description:
T-DM1 resistant/refractory (R/R) patients in the high dose treatment group
Treatment:
Drug: DS-8201a
Exploratory Arm
Other group
Description:
In Part 2b- Continuation Stage, about 10 T-DM1 Intolerant patients will receive the DS-8201a recommended dose (RD) as an exploratory arm
Treatment:
Drug: DS-8201a

Trial documents
1

Trial contacts and locations

99

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems