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Clinical Trials List

Protocol NumberD926QC00001
NCT Number(ClinicalTrials.gov Identfier)NCT06112379
Active

2023-10-01 - 2033-02-05

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 III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab With or Without Chemotherapy for the Treatment of Adult Patients With Previously Untreated Triple-Negative or Hormone Receptor-low/HER2-negative Breast Cancer (D926QC00001; TROPION-Breast04)

  • Trial Applicant

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 饒坤銘 Division of Hematology & Oncology
E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳守棟 Division of General Surgery
CHANGHUA CHRISTIAN 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

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 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 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 張源清 Division of General Surgery
MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wei-Pang Chung Division of General Internal Medicine
National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Breast Cancer

Objectives

This is a Phase 3, 2-arm, randomized, open-label, multicenter, global trial evaluating the lead-in Dato in participants with previously untreated TNBC or hormone receptor low-grade/HER2-negative breast cancer. -The efficacy and safety of DXd plus durvalumab, followed by adjuvant durvalumab with or without chemotherapy, compared with lead pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab with or without chemotherapy.

Test Drug

Datopotamab deruxtecanDurvalumab

Active Ingredient

Datopotamab deruxtecan
Durvalumab

Dosage Form

Lyophilised powder for concentrate for solution for infusion
Concentrate for solution for infusion

Dosage

20 mg/ml
50 mg/mL

Endpoints

double major
1. Demonstrating lead Dato-DXd plus durvalumab followed by adjuvant durvalumab with or without adjuvant durvalumab in participants with previously untreated TNBC or hormone receptor low-grade/HER2-negative breast cancer as assessed by central pCR Chemotherapy, compared with leading pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab with or without chemotherapy.
2. Demonstrating lead Dato-DXd plus durvalumab, followed by adjuvant durvalumab with or without, as assessed by trial moderator EFS, in participants with previously untreated TNBC or hormone receptor low-grade/HER2-negative breast cancer. plus chemotherapy versus lead pembrolizumab plus chemotherapy, followed by adjuvant pembrolizumab with or without chemotherapy.

Inclution Criteria

Inclusion Criteria:

Participant must be ≥ 18 years, at the time of signing the ICF.
Histologically confirmed Stage II or III unilateral or bilateral primary invasive TNBC or hormone receptor-low/HER2-negative breast cancer
ECOG PS of 0 or 1
Provision of acceptable tumor sample
Adequate bone marrow reserve and organ function
Contraceptive use by males or females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria

Exclusion criteria:

History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before randomization and of low potential risk for recurrence.
Evidence of distant disease.
Clinically significant corneal disease.
Has active or uncontrolled hepatitis B or C virus infection.
Known HIV infection that is not well controlled.
Uncontrolled infection requiring i.v. antibiotics, antivirals or antifungals; suspected infections; or inability to rule out infections.
Known to have active tuberculosis infection
Resting ECG with clinically significant abnormal findings.
Uncontrolled or significant cardiac disease.
History of non-infectious ILD/pneumonitis
Any prior or concurrent surgery, radiotherapy or systemic anticancer therapy for TNBC or hormone receptor-low/HER2-negative breast cancer
For females only: is pregnant (confirmed with positive serum pregnancy test) or breastfeeding, or planning to become pregnant.
Female participants should refrain from breastfeeding from enrolment throughout the study and for at least 7 months after last dose of study intervention, or as dictated by local PI for SoC if longer.

The Estimated Number of Participants

  • Taiwan

    80 participants

  • Global

    1900 participants

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