UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057601 |
|---|---|
| Receipt number | R000065815 |
| Scientific Title | A Chart Review Study of T-DXd following ILD in HER2+/ HER2-Low Breast Cancer Patients |
| Date of disclosure of the study information | 2025/06/15 |
| Last modified on | 2025/04/22 07:57:30 |
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Basic information
Public title
A Retrospective Cohort Study of T-DXd administration in HER2-Positive, Low-Expressing Advanced Breast Cancer Patients with History of Interstitial Lung Disease.
Acronym
A retrospective study on the administration of T-DXd in patients with a history of interstitial lung disease.
Scientific Title
A Chart Review Study of T-DXd following ILD in HER2+/ HER2-Low Breast Cancer Patients
Scientific Title:Acronym
A retrospective study on the administration of T-DXd in patients with a history of interstitial lung disease.
Region
| Japan |
Condition
Condition
advanced recurrent breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety and effectiveness of T-DXd in patients with ILD history.
Cohort 1:ILD history by T-DXd
Cohort 2 ILD history by anticancer drugs other than T-DXd
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ratio of recurrent ILD, Grade of recurrent ILD
Definition of ILD recurrence: Worsening of the ILD grade at the time of the re-administration of T-DXd (Cohort 1), compared to the initial administration of T-DXd (Cohort 2).
Key secondary outcomes
Ratio of recurrent ILD, Grade of recurrent ILD(investigator assessment)
TTF(Time to Treatment Failure)
PFS(progression-free survival)
TTP(time to progression)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Female
Key inclusion criteria
Cohort 1:
1. Patients diagnosed with HER2 positive (IHC3+ or IHC2+ ISH+) or low HER2 expression (IHC1+ or IHC2+ ISH-) advanced or metastatic breast cancer.
2. Patients who received T-DXd and had ILD of Grade1* history by T-DXd.
*Asymptomatic steroidal cases are included in Grade1
3. Patients who started T-DXd retreatment between December 2022 and June 2025 after ILD recovery, with or without other breast cancer medications prior to T-DXd retreatment.
4. Patients who can provide CT scan images for central review.
Cohort 2:
1. Patients diagnosed with HER2 positive (IHC 3+ or IHC2+ ISH+) or low HER2 expression (IHC1+ or IHC2+ ISH-) advanced or metastatic breast cancer.
2. Patients with a history of ILD (with any Grade) by anticancer drugs other than T-DXd (endocrine therapy, molecular targeted agents, chemotherapy, ADC other than T-DXd)
3. Patients who started T-DXd treatment between December 2021 and June 2025 after ILD recovery.
4. Patients who can provide CT scan images for central review.
Key exclusion criteria
Cohort 1, 2:
1. Patients with a history or complications of radiotherapy induced radiological ILD requiring interventional treatment
2. Patients with a history or complications of idiopathic ILD
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Michiko |
| Middle name | |
| Last name | Harao |
Organization
Jichi Medical University
Division name
Department of Surgery, Division of Gastroenterological, General and Transplant Surgery
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken
TEL
0285-58-7371
miharao@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Michiko |
| Middle name | |
| Last name | Harao |
Organization
Jichi Medical University
Division name
Department of Surgery, Division of Gastroenterological, General and Transplant Surgery
Zip code
329-0498
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken
TEL
0285-58-7371
Homepage URL
miharao@jichi.ac.jp
Sponsor or person
Institute
CSPOR-BC
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO COMPANY, LIMITED
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical university
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi-ken
Tel
0285587371
miharao@jichi.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2025 | Year | 02 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2025 | Year | 04 | Month | 13 | Day |
Last modified on
| 2025 | Year | 04 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065815
