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Clinical Trials List

Protocol NumberD9670C00001
NCT Number(ClinicalTrials.gov Identfier)NCT04494425
Active

2020-07-01 - 2027-12-31

Phase III

Recruiting8

ICD-10C50.911

Malignant neoplasm of unspecified site of right female breast

ICD-10C50.912

Malignant neoplasm of unspecified site of left female breast

ICD-10C50.919

Malignant neoplasm of unspecified site of unspecified female breast

ICD-10Z51.12

Encounter for antineoplastic immunotherapy

ICD-9174.9

Malignant neoplasm of female breast, unspecified

A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator's Choice Chemotherapy in HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting (DESTINY-Breast06)

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator TSU-YI CHAO Division of Hematology & Oncology
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ling-Ming Tseng Division of General Surgery
Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wei-Pang Chung Division of Hematology & Oncology
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator HWEI-CHUNG WANG Division of General Surgery
China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳威宇 Division of Hematology & Oncology
Chi Mei Medical Center

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 張源清 Division of General Surgery
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chiun-Sheng Huang Division of General Surgery
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Shin-Cheh Chen Division of General Surgery
Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

HER2-Low, Hormone Receptor Positive Breast Cancer Patients Whose Disease Has Progressed on Endocrine Therapy in the Metastatic Setting

Objectives

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting. Eligible patients will be those patients who have had disease progression on at least 2 previous lines of endocrine therapies given for the treatment of metastatic disease. All patients must have historically confirmed HR positive (either estrogen receptor and/or progesterone receptor positive), HER2-low (defined as IHC2+/ISH- and IHC 1+) or HER2 IHC >0 <1+ expression, as determined by central laboratory testing results, advanced or metastatic breast cancer. The study aims to evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy. This study aims to see if trastuzumab deruxtecan allows patients to live longer without the cancer getting worse, or simply to live longer, compared to patients receiving standard of care chemotherapy. This study is also looking to see how the treatment and the cancer affects patients' quality of life.

Test Drug

Trastuzumab deruxtecan (ENHERTUR)

Active Ingredient

Trastuzumab deruxtecan (DS-8201a、T-DXd或AZD4552)

Dosage Form

IVT

Dosage

20 mg/mL

Endpoints

Primary Outcome Measures :
Progression Free Survival (PFS) - in HR+, HER2-low populaton [ Time Frame: Until progression or death, assessed up to approximately 60 months ]
Defined as time from date of randomization until the date of objective radiological disease progression by blinded independent central review (BICR) assessment according to RECIST 1.1 or death.

Inclution Criteria

Key Inclusion Criteria:

Patients must be ≥18 years of age
Pathologically documented breast cancer that:

is advanced or metastatic
has a history of HER2-low or negative expression defined as IHC 2+/ISH- or IHC 1+ (ISH- or untested) or HER2 IHC 0 (ISH- or untested)
has HER2-low or HER2 IHC >0 <1+ expression
was never previously HER2-positive
is documented HR+ disease in the metastatic setting.
No prior chemotherapy for advanced or metastatic breast cancer.
Has adequate tumor samples for assessment of HER2 status
Either disease progression on at least 2 previous lines of endocrine therapy with or without a targeted therapy in the metastatic setting or disease progression within 24 months of starting adjuvant endocrine therapy and on at least 1 previous line of endocrine therapy in the metastatic setting
Has protocol-defined adequate organ and bone marrow function

Exclusion Criteria

Key Exclusion Criteria:

Ineligible for all options in the investigator's choice chemotherapy arm
Lung-specific intercurrent clinically significant illnesses
Uncontrolled or significant cardiovascular disease or infection
Active or prior documented interstitial lung disease (ILD)/pneumonitis or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
Patients with spinal cord compression or clinically active central nervous system metastases
Prior randomization or treatment in a previous trastuzumab deruxtecan study regardless of treatment arm assignment

The Estimated Number of Participants

  • Taiwan

    30 participants

  • Global

    850 participants

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