DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02]

Conditions

• Breast Cancer

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Trastuzumab deruxtecan — DRUG
  DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as intravenous (IV) dose
• Capecitabine — DRUG
  Investigator's choice Standard of Care when combined with trastuzumab or lapatinib
• Lapatinib — DRUG
  Investigator's choice Standard of Care when combined with capecitabine
• Trastuzumab — DRUG
  Investigator's choice Standard of Care when combined with capecitabine

Study Details

This study will compare DS 8201a to standard treatment. Participants must have HER2 breast cancer that has been treated before. Their cancer: * cannot be removed by an operation * has spread to other parts of the body

Key Dates

Start date

Aug 1, 2018

Status verified

Feb 2026

Primary completion

Jun 30, 2022

Completion

Dec 23, 2025

Study Design

Enrollment

608 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Trastuzumab deruxtecan (DS-8201a)
  HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to treatment with DS-8201a
• Active Comparator: Trastuzumab+capecitabine
  HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Trastuzumab/capecitabine
• Active Comparator: Lapatinib+capecitabine
  HER2 positive, unresectable and/or metastatic breast cancer participants previously treated with standard of care HER2 therapies, including ado-trastuzumab emtansine (T-DM1), randomized to investigator's choice treatment with Lapatinib/capecitabine

Primary Outcome Measure

Progression-Free Survival (PFS) Based on Blinded Independent Central Review (BICR) in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine [ Time Frame: Baseline up to 46 months postdose ]

Locations (41)

Find similar trials in Chandler, AZ

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