Clinical Trials /

DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer [DESTINY-Breast01]

NCT03248492

Description:

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.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Active, not recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
  • 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 Who Are Resistant or Refractory to T-DM1

Clinical Trial IDs

  • ORG STUDY ID: DS8201-A-U201
  • SECONDARY ID: 2016-004986-18
  • SECONDARY ID: JapicCTI-173693(en)
  • NCT ID: NCT03248492

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
DS-8201aExperimental productDS-8201a Low Dose

Purpose

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.

Trial Arms

NameTypeDescriptionInterventions
DS-8201a Low DoseExperimentalT-DM1 resistant/refractory (R/R) patients in the low dose treatment group
  • DS-8201a
DS-8201a Medium DoseExperimentalT-DM1 resistant/refractory (R/R) patients in the medium dose treatment group
  • DS-8201a
DS-8201a High DoseExperimentalT-DM1 resistant/refractory (R/R) patients in the high dose treatment group
  • DS-8201a
Exploratory ArmOtherIn Part 2b- Continuation Stage, about 10 T-DM1 Intolerant patients will receive the DS-8201a recommended dose (RD) as an exploratory arm
  • DS-8201a

Eligibility Criteria

        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 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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Objective response rate (ORR) per imaging assessment
Time Frame:within 22 months
Safety Issue:
Description:Percentage of participants with objective response is assessed every six weeks from Cycle 1 Day 1 through disease progression, by independent central imaging facility review based on RECIST version 1.1

Secondary Outcome Measures

Measure:Duration of response
Time Frame:within 22 months
Safety Issue:
Description:Length of time response continued
Measure:Best percent change in the sum of the longest diameters (SLD) of measurable tumors
Time Frame:within 22 months
Safety Issue:
Description:The best percent change from baseline in the SLD will be provided by part/dose group
Measure:Disease control rate (DCR)
Time Frame:within 22 months
Safety Issue:
Description:Percentage of participants with controlled disease
Measure:Clinical benefit rate (CBR)
Time Frame:within 22 months
Safety Issue:
Description:Percentage of participants receiving clinical benefit from the treatment
Measure:Progression-free survival
Time Frame:within 22 months
Safety Issue:
Description:Percentage of participants still alive without the disease getting worse
Measure:Overall survival (OS)
Time Frame:at 22 months
Safety Issue:
Description:Percentage of participants still alive
Measure:ORR assessed by the investigator based on RECIST version 1.1
Time Frame:within 22 months
Safety Issue:
Description:Percentage of participants with objective response as assessed by the investigator, based on RECIST version 1.1
Measure:Maximum plasma/serum concentration (Cmax)
Time Frame:within 21 days
Safety Issue:
Description:Categories: DS-8201a, total anti-HER2 antibody and MAAA-1181a
Measure:Time to Cmax (Tmax)
Time Frame:within 21 days
Safety Issue:
Description:Categories: DS-8201a, total anti-HER2 antibody and MAAA-1181a
Measure:Area under the concentration-time curve (AUC) from dosing until the last quantifiable concentration (AUClast)
Time Frame:within 21 days
Safety Issue:
Description:Categories: DS-8201a, total anti-HER2 antibody and MAAA-1181a
Measure:AUC from the time of dosing until day 21 (AUC0-21d)
Time Frame:at Day 21
Safety Issue:
Description:Categories: DS-8201a, total anti-HER2 antibody and MAAA-1181a

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Daiichi Sankyo, Inc.

Trial Keywords

  • HER-2 positive breast cancer
  • Metastatic or Unresectable
  • Resistant or refractory to T-DM1

Last Updated

October 19, 2017