DESTINY Breast Cancer Clinical Trials

A series of multinational trials studying fam-trastuzumab deruxtecan (DS-8201)
as a potential treatment option for eligible patients with metastatic breast cancer

This website reflects investigational compounds and/or investigational uses of approved products. The safety and efficacy of these investigational agents or investigational uses of approved products has not been established. Any approved products should be used in accordance with their product labeling (or Prescribing Information).

About fam-trastuzumab deruxtecan (DS-8201)

DS-8201 is currently being studied for a number of potential uses, including certain types of metastatic breast cancer. The three breast cancer trials below are currently ongoing. Click on each trial to learn more.

This clinical trial is comparing DS-8201 versus a treatment of physician's choice. Eligible patients must have HER2 positive breast cancer that has been treated before, including with ado-trastuzumab emtansine (T-DM1). Their cancer cannot be removed by an operation and/or must have spread to other parts of the body.

Click on the button below to find the nearest trial locations.
Please refer to this trial by its ClinicalTrials.gov identifier (NCT number): NCT03523585

This clinical trial is comparing DS-8201 versus ado-trastuzumab emtansine (T-DM1). Eligible patients must have HER2 positive breast cancer that has been previously treated with trastuzumab and taxane. Their cancer cannot be removed by an operation and/or has spread to other parts of the body.

Click on the button below to find the nearest trial locations.
Please refer to this trial by its ClinicalTrials.gov identifier (NCT number): NCT03529110

This clinical trial is comparing DS-8201 versus treatment of physician’s choice in patients with HER2 Low metastatic breast cancer that has spread or cannot be surgically removed.

Click on the button below to find the nearest trial locations.
Please refer to this trial by its ClinicalTrials.gov identifier (NCT number): NCT03734029

What is a Clinical Trial?

Clinical trials are part of clinical research that look at new ways to prevent, detect, or treat disease. Clinical trials can help to determine if new medicines are safe and effective. They are important as they, in many cases, may lead to medical advances and further understanding of potential treatment options for people. To participate in a clinical trial, people must volunteer at a participating trial location. Your doctor can explain the risks and benefits to you to help you determine if a trial is right for you as well as help you enroll.

Where Can I Find a Trial Location Site Near Me?

This website has a search feature to help you find trial locations near you.

The Daiichi Sankyo Cancer Enterprise has a broad and comprehensive clinical development program that is currently underway with fam-trastuzumab deruxtecan (DS-8201). This includes the following pivotal trials for metastatic breast cancer, which are currently ongoing.

Official Title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study of DS-8201, 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

Please refer to this trial by its ClinicalTrials.gov identifier (NCT number): NCT03523585

Primary Outcome Measures:

  • Progression-free survival (PFS) based on blinded independent central review (BICR) [Time Frame: Within 45 months]

    Time from the date of randomization to the first objective documentation of radiographic disease progression via BICR according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1, or death due to any cause.

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:
    • 4.5 months after the last dose of DS-8201a
    • 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
  • 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
From: U.S. National Library of Medicine. ClinicalTrials.gov Website.
https://clinicaltrials.gov/ct2/show/NCT03523585.

Official Title: A Phase 3, Multicenter, Randomized, Open-Label, Active-Controlled Study of DS-8201 (Trastuzumab Deruxtecan), an Anti-HER2 Antibody Drug Conjugate (ADC), Versus Ado Trastuzumab Emtansine (T-DM1) for HER2 Positive, Unresectable and/or Metastatic Breast Cancer Subjects Previously Treated With Trastuzumab and Taxane

Please refer to this trial by its ClinicalTrials.gov identifier (NCT number): NCT03529110

Primary Outcome Measures:

  • Progression-free survival (PFS) based on blinded independent central review (BICR) [Time Frame: Within 45 months]

    Time from the date of randomization to the earliest date of the first objective documentation of radiographic disease progression via BICR according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1 or death due to any cause.

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 trastuzumab and taxane in the advanced/metastatic setting or progressed within 6 months after neoadjuvant or adjuvant treatment involving a regimen including trastuzumab and taxane
  • 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.
  • If of reproductive/childbearing potential, agrees to use a highly effective form of contraception or avoid intercourse during and upon completion of the study for at least 4.5 months after the last dose of DS-8201a or 7 months after the last dose of T-DM1
  • Has adequate renal and hepatic function
Exclusion Criteria:
  • Has previously been treated with an anti-HER2 antibody drug conjugate (ADC)
  • Has uncontrolled or significant cardiovascular disease
  • Has a history of (noninfectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening
  • Has spinal cord compression or clinically active central nervous system (CNS) metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms.
    • Participants with clinically inactive brain metastases may be included in the study.
    • Participants with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.
From: U.S. National Library of Medicine. ClinicalTrials.gov Website.
https://clinicaltrials.gov/ct2/show/NCT03529110.

Official Title: A Phase 3, Multicenter, Randomized, Open-label, Active Controlled Trial of DS-8201, an Anti-HER2-antibody Drug Conjugate (ADC), Versus Treatment of Physician's Choice for HER2 Low, Unresectable and/or Metastatic Breast Cancer Subjects

Please refer to this trial by its ClinicalTrials.gov identifier (NCT number): NCT03734029

Primary Outcome Measures:

  • Progression-free survival (PFS) based on blinded independent central review (BICR) [Time Frame: within approximately 3 years]

    Time from the date of randomization to the earliest date of the first objective documentation of radiographic disease progression via blinded independent central review (BICR) according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) version 1.1 or death due to any cause.

Inclusion Criteria:
  • Is the age of majority in their country
  • Has pathologically documented breast cancer that:
    • is unresectable or metastatic
    • has low-HER2 expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested)
    • Is HR-positive or HR-negative
    • Has progressed on, and would no longer benefit from, endocrine therapy
    • Has been treated with 1 to 2 prior lines of chemotherapy/adjuvant in the metastatic setting
    • Was never previously HER2-positive (ICH 3+ or ISH+) on prior pathology testing (per American Society of Clinical Oncology-College of American Pathologists [ASCO-CAP] guidelines)
  • Has documented radiologic progression (during or after most recent treatment)
  • Has adequate tumor samples available or is willing to provide fresh biopsies prior to randomization for:
    • assessment of HER2 status
    • assessment of post-treatment status
  • Has Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1
  • Has at least 1 protocol-defined measurable lesion
  • Has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions
  • If of reproductive/childbearing potential, agrees to follow instructions for method(s) of contraception and agrees to avoid preserving ova or sperm for at least 4.5 months after treatment (or longer, per locally approved labels)
Exclusion Criteria:
  • Is ineligible for all options in the physician's choice arm
  • Has breast cancer ever assessed with high-HER2 expression
  • Has previously been treated with any anti-HER2 therapy, including an antibody drug conjugate
  • Has uncontrolled or significant cardiovascular disease
  • Has spinal cord compression or clinically active central nervous system metastases
  • Has history, current, or suspicion of interstitial lung disease/pneumonitis
  • Has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
From: U.S. National Library of Medicine. ClinicalTrials.gov Website.
https://clinicaltrials.gov/ct2/show/NCT03734029.

Find a Trial Location

This website has a search feature to find trial locations in some of the participating countries.

The information provided is intended for potential clinical investigators and other interested healthcare professionals who may wish to enroll or refer patients to clinical trials.