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Clinical Trials List

Protocol NumberD967JC00001
NCT Number(ClinicalTrials.gov Identfier)NCT04538742
Active

2020-10-15 - 2025-12-31

Phase I/II

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 1b/2 Multicentre, Open-label, Modular, Dose-finding and Dose-expansion Study to Explore the Safety, Tolerability, and Anti-tumour Activity of Trastuzumab Deruxtecan (T-DXd) in Combination With Other Anti-cancer Agents in Patients With HER2-positive Metastatic Breast Cancer (DESTINY-Breast07)

  • Trial Applicant

  • Sponsor

    AstraZeneca

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

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

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 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 Yao-Yu Hsieh 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 戴明燊 Division of Hematology & Oncology
Tri-Service General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 朱崧肇 Division of Hematology & Oncology
Hualien Tzu Chi Hospital

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

Condition/Disease

HER2-positive Metastatic Breast Cancer

Objectives

This study is modular in design allowing assessment of safety, tolerability and anti-tumour activity of T-DXd in combination with other anti-cancer agents. Combination-treatment modules will have 2 parts: a dose-finding phase (Part 1), and a dose expansion phase (Part 2); the recommended Phase 2 dose (RP2D) determined in Part 1 will be used for the dose-expansion in Part 2. The target population of interest in this study is patients with HER2-positive (as per ASCO/CAP 2018 guidelines) advanced/MBC inclusive of patients with active and stable brain metastases. Part 1 of each module will enroll patients with locally assessed HER2-positive advanced/MBC in second-line or later patients. Part 2 of each module will enroll patients with locally assessed HER2-positive breast cancer who have not received prior treatment for advanced/metastatic disease.

Test Drug

Trastuzumab deruxtecan (ENHERTUR)

Active Ingredient

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

Dosage Form

injection

Dosage

20 mg / vial

Endpoints

NA

Inclution Criteria

Key Inclusion Criteria:

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

Is advanced/unresectable (patients that can be treated with curative intent are not eligible) or metastatic
HER2-positive (IHC 3+ or IHC 2+/ISH+) based on local assessment
Is documented as hormone receptor-positive (estrogen or progesterone receptor) or negative in the metastatic setting
Patient must have adequate tumor sample for biomarker assessment
ECOG Performance Status of 0 or 1
Part 1

Disease progression on or after the last systemic therapy prior to starting study treatment
At least 1 prior treatment line in metastatic setting required.
Part 2 (Modules 0 - 5)

a) No prior lines of therapy for advanced/MBC allowed

Part 2 (Module 6 and 7) a) Zero or one prior lines of therapy for advanced/MBC allowed
CNS Inclusion

Modules 0 - 5 Patients must have no brain metastases or stable brain metastases.
Module 6 and 7 Patients must have untreated brain metastases not needing local therapy or previously treated brain metastases that have progressed since prior local therapy

Exclusion Criteria

Key Exclusion Criteria:

Uncontrolled or significant cardiovascular disease
Active or prior documented (non-infectious) ILD/pneumonitis that required steroids, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening
Lung-specific intercurrent clinically significant illnesses
Uncontrolled infection requiring IV antibiotics, antivirals, or antifungals
Spinal cord compression or a history of leptomeningeal carcinomatosis
Prior treatment with immune checkpoint inhibitors
Prior treatment with an ADC containing a topoisomerase I inhibitor
Prior treatment with tucatinib
CNS Exclusion

Modules 0 - 5: Has untreated brain metastasis
Module 6 and 7: Ongoing use of systemic corticosteroids for control of symptoms of brain metastases or brain lesion thought to require immediate local therapy

The Estimated Number of Participants

  • Taiwan

    34 participants

  • Global

    350 participants

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