Overview
Sponsor-declared trial summary
Metastatic breast cancer
The primary objective of the MONITOR-RCT is to demonstrate that in patients with metastatic breast cancer, response monitoring based on FDG-PET/CT is superior to response monitoring based on CT with respect to overall survival. The objective will be based on applying standardized response evaluation criteria, using an …
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01], Diseases [C] - Neoplasms [C04]
- Trial duration
- 5 Jul 2024 → 30 Oct 2025
- Decision date (initial)
- 2024-03-25
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Diagnosis
The primary objective of the MONITOR-RCT is to demonstrate that in patients with metastatic breast cancer, response monitoring based on FDG-PET/CT is superior to response monitoring based on CT with respect to overall survival. The objective will be based on applying standardized response evaluation criteria, using an appropriate adaptation of the PERCIST criteria for FDG-PET/CT and the RECIST1.1 criteria for CT.
Secondary objectives 1
- Secondary objectives of the MONITOR-RCT are to demonstrate superiority with respect to the quality of life and time and exposure to treatment and to investigate the cost-effectiveness and the occurrence of adverse events.
Conditions and MedDRA coding
Metastatic breast cancer
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 6
- Women and men aged≥18 years
- Diagnosis of distant relapsed MBC (biopsy-verified) or de novo breast cancer (biopsy verification of primary tumor and disseminated disease at baseline scan)
- Considered eligible for first-line systemic treatment
- Considered eligible for continuous treatment monitoring by scans
- Signed informed consent
- Ability to read and understand Danish language
Exclusion criteria 4
- Pregnant or lactating women
- Ongoing oncological treatment for another cancer
- Exclusively brain metastasis
- Allergy to FDG
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Overall survival
Secondary endpoints 4
- Quality of life
- Time and exposure to treatment
- Cost-effectiveness
- Occurrence of adverse events
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
SCP31288914 · ATC
- Active substance
- Fludeoxyglucose (18F)
- Substance synonyms
- FLUDEOXYGLUCOSE F 18, FLUORODEOXYGLUCOSE F18, ALPHA-D-GLUCOPYRANOSE, 2-DEOXY-2-(FLUORO-18F), 18F-FLUDEOXYGLUCOSE
- Route of administration
- INTRAVENOUS
- Max daily dose
- 3 MBq/kg megabecquerel(s)/kilogram
- Max total dose
- 4 MBq/kg megabecquerel(s)/kilogram
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- V09IX04 — FLUDEOXYGLUCOSE (18F)
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J B Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Malene Grubbe Hildebrandt
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Malene Grubbe Hildebrandt
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, E-data capture, Code 8 |
Locations
1 EU/EEA country · 3 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ended | 30 | 3 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-07-05 | 2025-10-30 | 2024-07-05 | 2025-04-04 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-506550-20-00 | 3 |
| Protocol (for publication) | D4_Patient facing document EORTC-QLQ-BR45 questionnaire | 1 |
| Protocol (for publication) | D4_Patient facing document EORTC-QLQ-C30 questionnaire | 1 |
| Protocol (for publication) | D4_Patient facing document EQ-5D-5L questionnaire | 1 |
| Protocol (for publication) | D4_Patient facing document FACT-B questionnaire | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | G2_SmPC FLUDEOXYGLUCOSE (18F) | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_DK 2023-506550-20-00 | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-08 | Denmark | Acceptable 2024-03-25
|
2024-03-25 |
| 2 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-05-07 | Denmark | Acceptable 2024-03-25
|
2025-05-07 |
| 3 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-06-11 | Denmark | Acceptable 2025-06-13
|
2025-06-13 |