UMIN-CTR Clinical Trial

Public title

Examination of biomarkers for progression or long-term response in trastuzumab deruxtecan (EXPLORE study)

Acronym

EXPLORE study (JBCRG-TR04/R7000-J081-002)

Scientific Title

Examination of biomarkers for progression or long-term response in trastuzumab deruxtecan (EXPLORE study)

Scientific Title:Acronym

EXPLORE study (JBCRG-TR04/R7000-J081-002)

Region

Japan

Condition

HER2-negative or HER2-low unresectable or recurrent breast cancer

Classification by specialty

Hematology and clinical oncology

Breast surgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

To perform an exploratory analysis of biomarkers associated with early progression of T-DXd treatment by utilizing clinical information including T-DXd treatment and stored tumor tissue specimens in patients with HER2-positive or HER2-low unresectable/recurrent breast cancer

Basic objectives2

Others

Basic objectives -Others

Biomarker

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

1) HER2 expression status
2) Exploration of factors related to T-DXd efficacy

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1) Patients who are confirmed to be HER2 positive or HER2 low by a primary physician in accordance with the American Society of Clinical Oncology/College of American Pathologists guidelines.
2) Patients who have given their consent to participate in this study. However, if it is difficult to explain and give consent, they have not declined the use of their clinical information in the public announcement of the study contents.
3) Patients aged 18 years or older at the time of tumor tissue collection (metastatic/recurrent stage)
4) Patients have a history of T-DXd treatment as second to fourth line chemotherapy for unresectable or recurrent breast cancer.
5) T-DXd treatment meets the criteria for either early progression or efficacy.
< the criteria of early progression or effective cases (T-DXd treatment period and response)>
1. HER2 positive/early progression; 2nd line therapy: less than 9M, 3rd line therapy: less than 6M, 4th line therapy: less than 6M
2. HER2 positive/effective; 2nd line therapy: more than 20M or complete response (CR), 3rd line therapy: more than 11M or CR, 4th line therapy: more than 11M or CR
3. HER2 low expression/early progression; 2nd line therapy: less than 4M, 3rd line therapy: less than 4M, 4th line therapy: less than 4M
4. HER2 low expression /effective; 2nd line therapy: more than 10M or complete response (CR), 3rd line therapy: more than 10M or CR, 4th line therapy: more than 10M or CR
6) Patients must have archived tumor tissue samples from the metastatic/recurrent stage (at the time of diagnosis of unresectable or metastatic breast cancer or later) and before T-DXd treatment. However, for early progression cases, patients who only have samples from after progression of T-DXd treatment are also eligible. At the National Cancer Center Hospital, samples from which comprehensive consent has been obtained will be used.

Key exclusion criteria

1) Patients in which treatment was discontinued within the early progression criteria due to adverse events during T-DXd treatment
2) Patients who were treated T-DXd for reasons other than disease progression in effective groups
3) Patients who could not consent to the secondary use of information obtained in this study

Target sample size

120

Name of lead principal investigator

1st name	1) Tatsunori 2) Midori
Middle name
Last name	1) Shimoi 2) Morita

Organization

1) National Cancer Center Hospital
2) University Hospital Kyoto Prefectural University of Medicine

Division name

1) Department of Medical Oncology 2) Endocrine and Breast Surgery

Zip code

1) 104-0045 2) 602-8566

Address

1) 5-1-1 Tsukiji, Chuo-ku, Tokyo 2) 465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto

TEL

03-3542-2511

Email

tshimoi@ncc.go.jp

Name of contact person

1st name	Tatsunori
Middle name
Last name	Shimoi

Organization

National Cancer Center Hospital

Division name

Department of Medical Oncology

Zip code

104-0045

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

TEL

03-3542-2511

Homepage URL

Email

tshimoi@ncc.go.jp

Institute

Eisai Co.,Ltd.

Institute

Department

Personal name

Organization

Eisai Co.,Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Japan Breast Cancer Research Group (JBCRG)

Name of secondary funder(s)

Organization

NCC Ethical Review Support Section

Address

5-1-1 Tsukiji, Chuo-ku, Tokyo

Tel

03-3542-2511

Email

irst@ml.res.ncc.go.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

国立がん研究センター中央病院（東京都）、京都府立医科大学附属病院（京都府）、がん研究会有明病院（東京都）、昭和医科大学（東京都）、東京慈恵会医科大学附属病院（東京都）、大阪大学医学部附属病院（大阪府）、エーザイ株式会社（茨城県）、旭川医科大学（北海道）、埼玉医科大学国際医療センター（埼玉県）、青森県立中央病院（青森県）、金沢大学附属病院（石川県）、さいたま赤十字病院（埼玉県）、関西医科大学附属病院（大阪府）、県立広島病院（広島県）、独立行政法人国立病院機構大阪医療センター（大阪府）、市立貝塚病院（大阪府）、名古屋大学医学部附属病院（愛知県）、福島県立医科大学（福島県）、愛媛大学附属病院（愛媛県）、京都大学附属病院（京都府）

Date of disclosure of the study information

2025

Year

05

Month

19

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2024

Year

11

Month

15

Day

Date of IRB

2025

Year

02

Month

13

Day

Anticipated trial start date

2025

Year

06

Month

01

Day

Last follow-up date

2028

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study consists of a non-interventional retrospective observational study to collect clinical information, mainly on the history of T-DXd treatment, and a non-invasive translational study using archived tumor tissue samples. In this study, we will collect tumor tissue samples already obtained and stored at the facility from patients who meet the eligibility criteria, as well as survey information such as patient background and the effectiveness of T-DXd treatment. The collected clinical information will be compiled by group for T-DXd treatment effect and investigated as differences between groups. In addition, the archived tumor tissue samples provided for this study will be subjected to biomarker measurement, including immunohistochemistry analysis and protein and gene analysis. Then, using the provided patient information and biomarker measurement data, we will explore the biomarker characteristics of T-DXd treatment.

Registered date

2025

Year

05

Month

14

Day

Last modified on

2026

Year

06

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000066142