West Cancer Center

BREAST: METASTATIC: HER2+: Prior T-DM1: DESTINY-Breast02

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201a, an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Pretreated With Prior Standard of Care HER2 Therapies, Including T-DM1

Title

Daiichi Sankyo DS8201-A-U301

Study Title

Site Link

NCT03523585

Malignancy

Breast Cancer, Invasive breast Cancer, BC, IBC

Stage

Stage 4

Disease Setting

Metastatic/Palliative

Line Of Therapy

2nd Line or 3rd line (prior T-DM1)

Investigational Agent

Trastuzumab deruxtecan (DS8201a)

Drug Class

HER-2 targeted ADC

Greg Vidal, MD, PhD

Sponsor

Daiichi Sankyo, Inc.

Phase

Phase 3

Status

Closed to Accrual

Key Eligibility Criteria

Key Eligibility Criteria Details

Histologically confirmed unresectable or metastatic breast cancer
HER-2 positive (HER2+) by ASCO-CAP guidelines and confirmed by central lab
Previously treated with T-DM1
Progression following last treatment (cannot go on after stopping treatment for toxicity alone)
No prior capecitabine
No history of insterstitial lung disease or pneumonitis requiring steroids
No active CNS disease

Objective

Primary- PFS
Secondary- OS, ORR, DoR, CBR, PFS by investigator assessment

Assessment Frequency

Assessment Frequency 2

Assessment Frequency Link

Path

HER2 positive

Dosing Frequency

Control Agents

Study Protocol

Randomized

Yes