Clinical Trials List
2023-04-01 - 2031-04-25
Phase III
Not yet recruiting8
Recruiting1
ICD-10C50.011
Malignant neoplasm of nipple and areola, right female breast
ICD-10C50.012
Malignant neoplasm of nipple and areola, left female breast
ICD-10C50.019
Malignant neoplasm of nipple and areola, unspecified female breast
ICD-10Z51.12
Encounter for antineoplastic immunotherapy
ICD-9174.0
Malignant neoplasm of female breast, nipple and areola
A Phase III, Open-label, Randomised Study of Datopotamab Deruxtecan (Dato-DXd) With or Without Durvalumab Compared With Investigator's Choice of Chemotherapy (Paclitaxel, Nab-paclitaxel or Gemcitabine + Carboplatin) in Combination With Pembrolizumab in Patients With PD-L1 Positive Locally Recurrent Inoperable or Metastatic Triple-negative Breast Cancer (TROPION-Breast05)
-
Trial Applicant
-
Sponsor
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- Wen-Ling Kuo 無
- Wen-Chi Shen 無
- 阮昱翔 無
- 沈士哲 無
- 何蕙余 無
- Chan-Keng Yang 無
- 周旭桓 無
- Mengting Peng 無
- Chi-Chang Yu 無
- Yung-Chang Lin 無
- Chun-Hsiu Liu 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Chieh-Han Chuang 無
- 巫承哲 無
- 徐旭亮 無
- Shen Liang Shih 無
- Chung-Liang Li 無
- 甘蓉瑜 無
- Junping Shiau Shiau 無
- Fang-Ming Chen 無
- 高理鈞 無
- 高捷妮 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- Chih-Jung Chen 無
- 蘇孟夏 無
- Chen-Teng Wu 無
- Yao-Chung Wu 無
- Liang-Chih Liu 無
- 黃至豪 無
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Co-Principal Investigator
- 林燕淑 無
- Chun-Yu Liu 無
- 郭懿萱 無
- Chi-Cheng Huang 無
- 邱仁輝 無
- 馮晉榮 無
- Yi-Fang Tsai 無
- 鄭涵方 無
- Jiun-I Lai 無
- 陳彥蓁 無
- Ta-Chung Chao 無
- 賴亦貞 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Durvalumab (MEDI4736)
Dosage Form
concentrate for solution for infusion
Dosage
50 mg/ml
Endpoints
Inclution Criteria
Histologically or cytologically documented locally recurrent inoperable, which cannot be treated with curative intent, or metastatic TNBC, as defined by the ASCO-CAP guidelines.
ECOG PS 0 or 1.
All participants must provide a FFPE metastatic or locally recurrent inoperable tumour sample.
PD-L1 positive TNBC based on results from an appropriately validated investigational PD-L1 (22C3) assay (CPS ≥ 10) from a sponsor designated central laboratory.
No prior chemotherapy or targeted systemic anti-cancer therapy for metastatic or locally recurrent inoperable breast cancer.
- Patients with recurrent disease will be eligible if they have completed treatment for Stage I-III breast cancer, if indicated, and ≥6 months have elapsed between completion of treatment with curative intent and the first documented recurrence.
Eligible for one of the chemotherapy options listed as ICC (paclitaxel, nab-paclitaxel, or gemcitabine + carboplatin).
Measurable disease as per RECIST 1.1.
Adequate bone marrow reserve and organ function.
Male and female participants of childbearing potential must agree to use protocol-specified method(s) of contraception.
Exclusion Criteria
As judged by investigator, severe or uncontrolled medical conditions including systemic diseases, history of allogeneic organ transplant and active bleeding diseases, ongoing or active infection, significant cardiac or psychological conditions.
History of another primary malignancy except for malignancy treated with curative intent with no known active disease within 3 years before Cycle 1 Day 1 and of low potential risk for recurrence.
Neoplastic spinal cord compression or active brain metastases, leptomeningeal carcinomatosis or history of leptomeningeal carcinomatosis.
- Participants with treated clinically inactive brain metastases that are no longer symptomatic, who require no treatment with corticosteroids or anticonvulsants, may be included in the study if they have recovered from acute toxic effects of radiotherapy.
Uncontrolled infection requiring IV antibiotics, antivirals or antifungals.
Active or uncontrolled hepatitis B or C virus infection.
Known HIV infection that is not well controlled.
Uncontrolled or significant cardiac disease.
History of non-infectious ILD/pneumonitis (including radiation pneumonitis) that required steroids, current ILD/pneumonitis, or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening.
Severe pulmonary function compromise.
Clinically significant corneal disease.
Active or prior documented autoimmune or inflammatory disorders.
Prior exposure to any treatment including ADC containing a chemotherapeutic agent targeting topoisomerase I and TROP2-targeted therapy.
Any concurrent anti-cancer treatment.
Participants with a known severe hypersensitivity to PD-1/PD-L1 inhibitors or Dato-DXd.
Currently pregnant (confirmed with positive pregnancy test), breastfeeding or planning to become pregnant.
The Estimated Number of Participants
-
Taiwan
32 participants
-
Global
625 participants
