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Completed

NCT Number: NCT03523585

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

St Vincent's Hospital Sydney, Darlinghurst, New South Wales, Australia

Loading trial locations.

About this study

The study is designed to compare DS 8201a versus standard of care (investigator's choice) in subjects with unresectable and/or metastatic breast cancer previously treated with T-DM1.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Is the age of majority in their country
  • Has pathologically documented breast cancer that:
  • is unresectable or metastatic
  • has confirmed HER2-positive expression as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
  • was previously treated with ado-trastuzumab emtansine (T-DM1)
  • Has documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy)
  • Is HER2 positive as confirmed by central laboratory assessment of most recent tumor tissue sample available. If archived tissue is not available, agrees to provide a fresh biopsy.
  • Male and female participants of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least:
  • 7 months after the last dose of DS-8201a (females); 4.5 months after last dose of DS-8201a (males)
  • 6 months after the last dose of lapatinib/capecitabine for female participants (3 months for male participants)
  • 7 months after the last dose of trastuzumab/capecitabine
  • Has adequate hematopoietic, renal and hepatic functions

Exclusion criteria

  • Has previously participated in an antibody drug conjugate study sponsored by Daiichi Sankyo. Prior treatment in the adjuvant/neo-adjuvant setting would be allowed if progression of disease did not occur within 12 months of end of adjuvant therapy
  • Has had prior treatment with capecitabine
  • Has uncontrolled or significant cardiovascular disease
  • Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
  • Has active central nervous system (CNS) metastases

Treatment and study plan

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

Other names: DS-8201a, T-DXd

Capecitabine

Drug

Investigator's choice Standard of Care when combined with trastuzumab or lapatinib

Other names: Investigator's Choice Comparative Therapy

Lapatinib

Drug

Investigator's choice Standard of Care when combined with capecitabine

Other names: Investigator's Choice Comparative Therapy

Trastuzumab

Drug

Investigator's choice Standard of Care when combined with capecitabine

Other names: Investigator's Choice Comparative Therapy

Primary outcomes

  1. 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

    Progression-free survival (PFS) by BICR was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause.

Secondary outcomes

  1. Overall Survival (OS) 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

    Overall survival (OS) was defined as the time from the date of randomization to the date of death due to any cause. If there is no death reported for a subject before the data cutoff for OS analysis, OS will be censored at the last contact date at which the subject is known to be alive.

  2. Percentage of Participants With Objective Response Rate (ORR) 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

    The Objective Response Rate (ORR) was defined as the percentage of participants who achieved a best overall response of confirmed Complete Response (CR) or Partial Response (PR), assessed by BICR and investigator assessment based on RECIST version 1.1. CR was defined as a disappearance of all target lesions and PR was defined as at least a 30% decrease in the sum of diameters of target lesions. Confirmed ORR based on BICR and Investigator Assessment is reported.

  3. Duration of Response (DoR) Based on 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

    Duration of Response (DoR) was defined as the time from the date of the first documentation of objective response (complete response [CR] or partial response [PR]) to the date of the first objective documentation of progressive disease (PD) or death due to any cause. DoR in participants with confirmed CR/PR based on BICR and investigator assessment is reported.

  4. Progression-Free Survival (PFS) Based on Investigator Assessment in Participants With HER2-positive, Unresectable and/or Metastatic Breast Cancer Participants Previously Treated With Trastuzumab Emtansine

    Time frame: Up to 46 months

    Progression-free survival (PFS) by investigator assessment was defined as the time from the date of randomization to the earlier of the dates of the first objective documentation of disease progression (as per RECIST v1.1) or death due to any cause.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Collaborators

  • AstraZeneca
  • Daiichi Sankyo Co., Ltd.

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2-antibody Drug Conjugate, Versus Treatment of Investigator's Choice for HER2-positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With T-DM1

Important dates

Study start
2018
Primary completion
2022
Study completion
2025
First posted
May 14, 2018
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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