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

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:

  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

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:

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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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