Advanced Breast CancerPhase 2ESPERONCT05530057
Eribulin With or Without Trastuzumab-biosimilar in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer
A Phase 2 study testing Eribulin Mesylate + Samfenet (Trastruzumab-biosimilar) and Eribulin Mesylate in people with Advanced Breast Cancer, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Optimal salvage treatment for HER2-positive breast cancer after trastuzumab and T-DM1 failure still remains to be established. We would like to investigate the efficacy and safety of combination chemotherapy of eribulin and trastuzumab as salvage treatment for HER2-Positive breast cancer after exposure to trastuzumab… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Advanced Breast Cancer
- What is being tested?
- Eribulin Mesylate + Samfenet (Trastruzumab-biosimilar) and Eribulin Mesylate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Feb 2020to 30 Jun 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years old.
- Pathologically documented breast cancer that:
- is unresectable or metastatic
- has confirmed HER2 positive expression (immunohistochemistry or FISH) as determined according to American Society of Clinical Oncology - College of American Pathologists guidelines evaluated at a central laboratory
- was previously treated with trastuzumab, T-DM1 or T-Dxd, and taxane (whether in recurrent/metastatic setting or neoadjuvant/adjuvant setting).
- Less than 4 prior lines of chemotherapy or HER2 targeted therapies for treatment in metastatic disease (<4 treatment regimens for recurrent/metastatic disease excluding adjuvant treatments)
Show all 18Show fewer
- Documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
- Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 4.5 months after the last dose of study treatment.
- Adequate hematopoietic, renal and hepatic functions.
- Adequate hematopoietic function: Absolute granulocyte count ≥1,500/mm3, platelet≥100,000/mm3, hemoglobin≥10g/mm3
- Adequate hepatic function: total bilirubin ≤2.0mg/dL, AST/ALT ≤2 x UNL, alkaline phosphatase ≤2.5 x UNL, in case with bone metastases alkaline phosphatase ≤5 x UNL
- Adequate renal function: Serum creatinine ≤1.5mg/dL
- a left ventricular ejection fraction of 50% or more (determined by echocardiography or multiple-gated acquisition [MUGA(Multigated Blood Pool Scan)] scanning)
- CNS(central nervous system) metastasis is permitted if asymptomatic or controlled with minimal steroid requirement and is documented to be non-progressing at study entry.
- Negative result for urine or serum pregnancy tests within the screening period in premenopausal patients
- Ability to understand and comply with protocol during study period
- Patients should sign a written informed consent before study entry
Who cannot join
- Prior treatment with eribulin
- Uncontrolled or significant cardiovascular disease
- History of documented congestive heart failure (CHF) or systolic dysfunction (LVEF <50%)
- High-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade Atrioventricular-block, supraventricular arrhythmias, prolonged QTc(corrected QT interval) which are not adequately rate-controlled)
- Angina pectoris requiring antianginal medication
- Clinically significant valvular heart disease
Show all 14Show fewer
- Evidence of transmural infarction on ECG
- Poorly controlled hypertension (e.g. systolic >180mm Hg or diastolic >100mm Hg)
- Pregnant or lactating women or women of childbearing potential, including women whose last menstrual period was ,12 months ago (unless surgically sterile) who are unable or unwilling to use adequate contraceptive measures during the study treatment period.
- Patients who have history of cancer other than in situ uterine cervix cancer or nonmelanotic skin cancer and thyroid cancer. For other types of cancer, patients could be included if there is no evidence of disease for more than 2 years.
- Patients with GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled GI disease (e.g., Crohn's disease, ulcerative colitis)
- Subjects who have current active hepatic or biliary disease (with exception of patients with Gilbert's syndrome, asymptomatic gallstones, liver metastases or stable chronic liver disease per investigator assessment)
- Concurrent disease or serious medical disorder, for example, active or uncontrolled infection, interstitial lung disease (ILD) or any psychiatric condition prohibiting understanding or rendering of informed consent.
- Patients who have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to any of the study agents or their excipients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kyunghun Lee, MD,PhD contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul
Yuri Park, RN, 82-0-2072-0795
Seock-Ah Im, MD,PhD
About this study
Official title: Randomized, Open Label, Multi-Center, Phase II Trial of Eribulin With or Without SB3 (Trastuzumab-biosimilar) in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer Who Have Received at Least 2 Prior HER2-directed Regimens
Optimal salvage treatment for HER2-positive breast cancer after trastuzumab and T-DM1 failure still remains to be established. We would like to investigate the efficacy and safety of combination chemotherapy of eribulin and trastuzumab as salvage treatment for HER2-Positive breast cancer after exposure to trastuzumab and T-DM1
Read the detailed description
HER2-targeted therapy is the mainstay therapeutic option for the treatment of HER2 positive breast cancer patients. Even after progression on HER2-targeted therapy, HER2 remains an effective therapeutic target. In a phase III randomized clinical trial, Lapatinib plus capecitabine showed superior outcome compared to capecitabine alone in HER2 positive breast cancer patients who has progressed after trastuzumab-based therapy Moreover, ado-trastuzumab emtansine (T-DM1) showed improved progression free survival (PFS) and overall survival (OS) in HER2-positive advanced breast cancer patients previously treated with trastuzumab and a taxane.
Not only switching to a different HER2-targeted agent, but rechallenge of trastuzumab has also shown efficacy in trastuzumab failed HER2-positive breast cancer patients. In HER2-positive breast cancer patients who failed trastuzumab and lapatinib, rechallenge of trastuzumab in combination with conventional chemotherapy showed response rate of 31%, PFS of 4.9 months, and OS of 19.4 months.
Eribulin mesylate is a non-taxane inhibitor of microtubule which shows efficacy in HER2-positive breast cancer. The efficacy of eribulin and trastuzumab combination chemotherapy as first line palliative chemotherapy in HER2-positive breast cancer was identified in a phase II trial. Eribulin plus trastuzumab was an effective regimen which showed response rate of 71.2% and PFS of 11.6 months.
Currently, the first line regimen for HER2-positive metastatic breast cancer is combination therapy of pertuzumab, trastuzumab, and docetaxel as a result of the CELOPARTRA trial . After failure on pertuzumab and trastuzumab based combination chemotherapy, T-DM1 is frequently used as a 2nd line therapy. Optimal salvage treatment for HER2-positive breast cancer after trastuzumab and T-DM1 failure still remains to be established. We would like to investigate the efficacy and safety of combination chemotherapy of eribulin and trastuzumab as salvage treatment for HER2-Positive breast cancer after exposure to trastuzumab and T-DM1.
- Conditions
- Advanced Breast Cancer
- Being tested
- Eribulin Mesylate + Samfenet (Trastruzumab-biosimilar), Eribulin Mesylate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Eribulin Mesylate + Samfenet (Trastruzumab-biosimilar)Drug
- Patients will receive eribulin mesylate 1.4 mg/m2 administered I.V. with infusion over 2 to 5 minutes on days 1 and 8 of each 21-day cycle and SB3 8 mg/kg I.V. over 90 minutes on day 1 of cycle 1 . Thereafter, SB3 6 mg/kg will be infused over 30 minutes on day 1 of each subsequent 21-day cycle until progression or unacceptable toxicity.
- Dose reductions for eribulin, but not for SB3, is permitted.
- Two dose reductions (1.1, 0.7 mg/m2) are allowed for eribulin before consideration of study treatment discontinuation. Eribulin could be continued as monotherapy if trastuzumab-similar was discontinued, and vice-versa.
Eribulin MesylateDrug
- Patients will receive eribulin mesylate 1.4 mg/m2 administered I.V. with infusion over 2 to 5 minutes on days 1 and 8 of each 21-day cycle until progression or unacceptable toxicity.
- Two dose reductions (1.1, 0.7 mg/m2) are allowed before consideration of study treatment discontinuation.
| Study group | Role | What they receive |
|---|---|---|
| Eribulin + SB3 | Experimental | - Patients will receive eribulin mesylate 1.4 mg/m2 administered I.V. with infusion over 2 to 5 minutes on days 1 and 8 of each 21-day cycle and SB3 8 mg/kg I.V. over 90 minutes on day 1 of cycle 1 . Thereafter, SB3 6 mg/kg will be infused over 30 minutes on day 1 of each subsequent 21-day cycle until progression or unacceptable toxicity. Receives: Drug: Eribulin Mesylate + Samfenet (Trastruzumab-biosimilar) |
| Eribulin monotherapy | Active comparator | - Patients will receive eribulin mesylate 1.4 mg/m2 administered I.V. with infusion over 2 to 5 minutes on days 1 and 8 of each 21-day cycle until progression or unacceptable toxicity. Receives: Drug: Eribulin Mesylate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint(PFS)
PFS is defined as the time from randomization to first documented disease progression as determined by the investigator using RECIST 1.1 or death from any cause, whichever occurs earlier.
Measured: First day of study treatment to the date of disease progression or death due to any cause, whichever came first, assessed up to 2 years
Secondary outcomes (5)
Objective response rate (ORR)
Objective response, defined as a CR or PR, will be determined by investigator tumor assessment using RECIST 1.1. Patients without a post-baseline tumor assessment will be considered non-responders.
Measured: Enrollment to end of treatment up to 2 years
Duration of objective response (DOR)
DOR is defined as the time from first occurrence of a documented objective response (PR or CR) to disease progression, as determined by investigator tumor assessment using RECIST 1.1, or death from any cause, whichever occurs first
Measured: Enrollment to end of treatment up to 2 years
Clinical benefit rate (CBR)
Clinical benefit rate, defined as having received CR or PR of any duration or stable disease (SD) ≥ 4 months per RECIST v1.1. Patients without a post-baseline tumor assessment will be considered non-responders
Measured: Enrollment to end of treatment up to 2 years
Overall survival (OS)
OS is defined as the time from randomization to death from any cause. Patients who are alive as of the data cut-off date of the analysis will be censored at the last known date they were alive
Measured: First day of study treatment to the date of death due to any cause, assessed up to 2 years
Safety profile (Treatment-related adverse events as assessed by CTCAE v4.0)
Number of participants with treatment-related adverse events will be assessed
Measured: First day of study treatment to end of treatment, assessed up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start18 Feb 2020
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Breast CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm A (Eribulin + SB3) Arm B (Eribulin monotherapy)
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seock-Ah Im, Seoul National University Hospital
- Investigators
- Seock-Ah Im, MD,PhD, Principal investigator, Study Principal Investigato
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530057
- Sponsor's protocol ID
- H-1905-141-1035
- Acronym
- ESPERO
- Status last verified
- Dec 2024
- First submitted
- 1 Sep 2022
- Last updated
- 20 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Open Label, Multi-Center, Phase II Trial of Eribulin With or Without SB3 (Trastuzumab-biosimilar) in Patients With HER2-overexpressed Recurrent or Stage IV Breast Cancer Who Have Received at Least 2 Prior HER2-directed Regimens
- ClinicalTrials.gov ID
- NCT05530057
- Acronym / sponsor ID
- ESPERO / H-1905-141-1035
- Conditions
- Advanced Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Optimal salvage treatment for HER2-positive breast cancer after trastuzumab and T-DM1 failure still remains to be established. We would like to investigate the efficacy and safety of combination chemotherapy of eribulin and trastuzumab as salvage treatment for HER2-Positive breast cancer after exposure to trastuzumab and T-DM1
Detailed description
HER2-targeted therapy is the mainstay therapeutic option for the treatment of HER2 positive breast cancer patients. Even after progression on HER2-targeted therapy, HER2 remains an effective therapeutic target. In a phase III randomized clinical trial, Lapatinib plus capecitabine showed superior outcome compared to capecitabine alone in HER2 positive breast cancer patients who has progressed after trastuzumab-based therapy Moreover, ado-trastuzumab emtansine (T-DM1) showed improved progression free survival (PFS) and overall survival (OS) in HER2-positive advanced breast cancer patients previously treated with trastuzumab and a taxane.
Not only switching to a different HER2-targeted agent, but rechallenge of trastuzumab has also shown efficacy in trastuzumab failed HER2-positive breast cancer patients. In HER2-positive breast cancer patients who failed trastuzumab and lapatinib, rechallenge of trastuzumab in combination with conventional chemotherapy showed response rate of 31%, PFS of 4.9 months, and OS of 19.4 months.
Eribulin mesylate is a non-taxane inhibitor of microtubule which shows efficacy in HER2-positive breast cancer. The efficacy of eribulin and trastuzumab combination chemotherapy as first line palliative chemotherapy in HER2-positive breast cancer was identified in a phase II trial. Eribulin plus trastuzumab was an effective regimen which showed response rate of 71.2% and PFS of 11.6 months.
Currently, the first line regimen for HER2-positive metastatic breast cancer is combination therapy of pertuzumab, trastuzumab, and docetaxel as a result of the CELOPARTRA trial . After failure on pertuzumab and trastuzumab based combination chemotherapy, T-DM1 is frequently used as a 2nd line therapy. Optimal salvage treatment for HER2-positive breast cancer after trastuzumab and T-DM1 failure still remains to be established. We would like to investigate the efficacy and safety of combination chemotherapy of eribulin and trastuzumab as salvage treatment for HER2-Positive breast cancer after exposure to trastuzumab and T-DM1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm A (Eribulin + SB3) Arm B (Eribulin monotherapy)
| Arm | Type | Receives |
|---|---|---|
| Eribulin + SB3 | Experimental | Drug: Eribulin Mesylate + Samfenet (Trastruzumab-biosimilar)- Patients will receive eribulin mesylate 1.4 mg/m2 administered I.V. with infusion over 2 to 5 minutes on days 1 and 8 of each 21-day cycle and SB3 8 mg/kg I.V. over 90 minutes on day 1 of cycle 1 . Thereafter, SB3 6 mg/kg will be infused over 30 minutes on day 1 of each subsequent 21-day cycle until progression or unacceptable toxicity. |
| Eribulin monotherapy | Active comparator | Drug: Eribulin Mesylate- Patients will receive eribulin mesylate 1.4 mg/m2 administered I.V. with infusion over 2 to 5 minutes on days 1 and 8 of each 21-day cycle until progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Adults ≥18 years old.
- Pathologically documented breast cancer that:
- Documented radiologic progression (during or after most recent treatment or within 6 months after completing adjuvant therapy).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1
- Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 4.5 months after the last dose of study treatment.
Key exclusion criteria (14 listed)
- Prior treatment with eribulin
- Uncontrolled or significant cardiovascular disease
- History of documented congestive heart failure (CHF) or systolic dysfunction (LVEF <50%)
- High-risk uncontrolled arrhythmias (ventricular tachycardia, high-grade Atrioventricular-block, supraventricular arrhythmias, prolonged QTc(corrected QT interval) which are not adequately rate-controlled)
- Angina pectoris requiring antianginal medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Eribulin Mesylate + Samfenet (Trastruzumab-biosimilar)* Patients will receive eribulin mesylate 1.4 mg/m2 administered I.V. with infusion over 2 to 5 minutes on days 1 and 8 of each 21-day cycle and SB3 8 mg/kg I.V. over 90 minutes on day 1 of cycle 1 . Thereafter, SB3 6 mg/kg will be infused over 30 minutes on day 1 of each subsequent 21-day cycle until progression or unacceptable toxicity. * Dose reductions for eribulin, but not for SB3, is permitted. * Two dose reductions (1.1, 0.7 mg/m2) are allowed for eribulin before consideration of study treatment discontinuation. Eribulin could be continued as monotherapy if trastuzumab-similar was discontinued, and vice-versa. | Drug | Eribulin + SB3 |
| Eribulin Mesylate* Patients will receive eribulin mesylate 1.4 mg/m2 administered I.V. with infusion over 2 to 5 minutes on days 1 and 8 of each 21-day cycle until progression or unacceptable toxicity. * Two dose reductions (1.1, 0.7 mg/m2) are allowed before consideration of study treatment discontinuation. | Drug | Eribulin monotherapy |
Primary outcome
Primary Efficacy Endpoint(PFS)
Time frame: First day of study treatment to the date of disease progression or death due to any cause, whichever came first, assessed up to 2 years
PFS is defined as the time from randomization to first documented disease progression as determined by the investigator using RECIST 1.1 or death from any cause, whichever occurs earlier.
5 secondary outcomes
Objective response rate (ORR)
Time frame: Enrollment to end of treatment up to 2 years
Duration of objective response (DOR)
Time frame: Enrollment to end of treatment up to 2 years
Clinical benefit rate (CBR)
Time frame: Enrollment to end of treatment up to 2 years
Overall survival (OS)
Time frame: First day of study treatment to the date of death due to any cause, assessed up to 2 years
Safety profile (Treatment-related adverse events as assessed by CTCAE v4.0)
Time frame: First day of study treatment to end of treatment, assessed up to 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Advanced Breast Cancer
Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
Colorectal Neoplasms, Breast Neoplasms
RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Active, not recruitingPhase 1
A Phase 1 Study of XL309 (ISM3091) Alone and in Combination in Participants With Advanced Solid Tumors
Advanced Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyunghun Lee, MD,PhD contact
Seock-Ah Im, MD,PhD principal investigator
Study Principal Investigato
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eribulin Mesylate + Samfenet (Trastruzumab-biosimilar) and Eribulin Mesylate in people with Advanced Breast Cancer, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seock-Ah Im, MD,PhD (82-2-2072-0850, moisa@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint(PFS) (time frame: First day of study treatment to the date of disease progression or death due to any cause, whichever came first, assessed up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.