UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051259 |
|---|---|
| Receipt number | R000058453 |
| Scientific Title | A multicenter prospective observational study to confirm the effectiveness and safety of trastuzumab deruxtecan for unresectable and/or metastatic breast cancer patients with HER2-low expression |
| Date of disclosure of the study information | 2023/06/16 |
| Last modified on | 2023/10/02 18:23:58 |
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Basic information
Public title
A multicenter prospective observational study to confirm the effectiveness and safety of trastuzumab deruxtecan for unresectable and/or metastatic breast cancer patients with HER2-low expression
Acronym
HALLOW study
Scientific Title
A multicenter prospective observational study to confirm the effectiveness and safety of trastuzumab deruxtecan for unresectable and/or metastatic breast cancer patients with HER2-low expression
Scientific Title:Acronym
HALLOW study
Region
| Japan |
Condition
Condition
Unresectable and/or metastatic breast cancer patients with HER2-low expression
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
･To confirm the effectiveness and safety of Trastuzumab Deruxtecan (T-DXd) for breast cancer patients with human epidermal growth factor receptor type 2 (HER2) -low expression in real clinical practice, mainly hormone receptor (HR)negative /HER2-low expression breast cancer among triple-negative breast cancer (TNBC).
･To confirm the effectiveness and safety of T-DXd for patients with breast cancer with brain metastasis in HER2 low expression.
･To evaluate and characterize the differences between HER2 scoring under clinical and central pathological diagnosis for breast cancer patients with HER2-low expression and their influences on effectiveness based on the results of HER2 scoring.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
<Effectiveness and safety endpoints>
･Overall survival (OS)
･Progression-free survival (PFS)
･Time to treatment failure (TTF)
･Time to treatment discontinuation (TTD)
･Time to next treatment (TTNT)
･PFS2
･TTF2
･TTNT2
･Objective response rate (ORR)
･Disease control rate (DCR)
･Clinical benefit rate (CBR)
･Duration of response (DOR)
･Patient background (height, weight, age, sex, Eastern Cooperative Oncology Group performance status (ECOG-PS) and Karnofsky Performance Status (Karnofsky-PS), etc.)
･Adverse events
- Grade 3 or higher adverse events
- Grade 1 or higher interstitial lung disease (ILD)
- Adverse events leading to discontinuation of T-DXd
･Death related to T-DXd treatment
･Patient Reported Outcome (PRO)
-Health-related quality of life (QOL)
-MD Anderson Symptom Inventory (MDASI) for brain tumor (MDASI-BT) -specific items
<Effectiveness endpoints for brain metastases>
･Intra cranial-ORR (IC-ORR)
･IC-CBR (Intra-cranial-CBR)
･IC-PFS (Intra-cranial-PFS)
<Endpoints in subgroups>
･The concordance rate between human epidermal growth factor receptor 2 (HER2) scoring under clinical settings and Pathological independent central review (Path-ICR)
･Effectiveness evaluation based on each result of HER2 scoring under clinical settings and Path-ICR
･Evaluation of effectiveness and safety, etc. in other subgroups
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 18 years or older at the time of informed consent
2. Patients with unresectable and/or metastatic breast cancer with HER2-low expression who previously treated with chemotherapy
3. Patients scheduled for T-DXd administration
4. Patients for whom written consent was obtained
Key exclusion criteria
1. Patients who are hypersensitive to T-DXd components
2. Patients with active multiple cancers (Carcinoma in situ considered curable by local treatment (carcinoma in situ) or intramucosal carcinoma equivalent lesions should not be included in active multiple cancers)
3. Patients judged by investigators to be ineligible for this study
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Shigehira |
| Middle name | |
| Last name | Saji |
Organization
Fukushima Medical University Hospital
Division name
Department of Medical Oncology
Zip code
960-1295
Address
1 Hikariga-oka, Fukushima, 960-1295, Japan
TEL
024-547-1511
ss-saji@wa2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Shigehira |
| Middle name | |
| Last name | Saji |
Organization
Fukushima Medical University Hospital
Division name
Department of Medical Oncology
Zip code
960-1295
Address
1 Hikariga-oka, Fukushima, 960-1295, Japan
TEL
024-547-1511
Homepage URL
ss-saji@wa2.so-net.ne.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
DAIICHI SANKYO CO., LTD.
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
Fukushima Medical University, Research Ethics Committee
Address
1 Hikariga-oka, Fukushima, 960-1295, Japan
Tel
024-547-1825
fmurec@fmu.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
| 2023 | Year | 06 | Month | 16 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 16 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 01 | Month | 31 | Day |
Other
Other related information
The treatment results of T-DXd in breast cancer patients with HER2-low expression were only around 400 cases in DESTINY-Breast04 (DB-04)/DS8201-A-J101 study, etc. The diverse and large Real World Evidence (RWE) for this drug, which has no analogues for the treatment of this patient population, is evidence of great medical value.
Effective pharmacotherapy for TNBC is the most significant Unmet Medical Needs (UMN) in breast cancer, and this study focusing on breast cancer with HR negative/HER2-low expression among TNBC may provide complementary evidence to DB-04. In addition, the effective pharmacotherapy for breast cancer patients with brain metastasis is UMN in which the medical necessity is even higher, and the data-generation will contribute to the public benefit.
Dissemination of diagnostic criteria for HER2-low expression and its concepts will make it possible to provide breast cancer patients with new treatment opportunities. And, it is expected that it can contribute to the penetration of proper diagnosis of HER2-low expression, and that it contributes to the accessibility expansion to the therapeutic drug of the patient.
Based on the significance of the above study, we planned this study.
Management information
Registered date
| 2023 | Year | 06 | Month | 05 | Day |
Last modified on
| 2023 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058453
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