Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruiting
Participants planned
67
Countries
1
Sites
4
Breast cancer
To assess the efficacy of oxybutynin versus venlafaxine in reducing hot flashes in women using endocrine therapy after breast cancer.
Key facts
- Sponsor
- Reinier de Graaf Groep
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04], Not possible to specify
- Trial duration
- 9 Aug 2024 → ongoing
- Decision date (initial)
- 2024-04-09
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2023-507847-13-00
- ClinicalTrials.gov
- NCT06106529
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy
To assess the efficacy of oxybutynin versus venlafaxine in reducing hot flashes in women using endocrine therapy after breast cancer.
Secondary objectives 1
- To assess side effects of oxybutynin versus venlafaxine. To assess the personal preference of women for oxybutynin versus venlafaxine in reducing hot flashes. To assess quality of life of women when reducing hot flashes in women using endocrine therapy after breast cancer.
Conditions and MedDRA coding
Breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10083233 | Triple positive breast cancer | 100000004864 |
| 23.0 | LLT | 10070575 | Estrogen receptor positive breast cancer | 10029104 |
| 23.0 | PT | 10083234 | Hormone receptor positive breast cancer | 100000004864 |
| 20.0 | PT | 10006187 | Breast cancer | 100000004864 |
| 23.0 | LLT | 10070577 | Oestrogen receptor positive breast cancer | 10029104 |
| 21.1 | PT | 10076935 | Hormone refractory breast cancer | 100000004864 |
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | The RED FLASH study The treatment duration in study period 1 is 6 weeks, followed by a two-week washout. The treatment duration in study period 2 is 6 weeks as well. Therefore, the duration of participation is 15 weeks per subject (from start randomization to end).
We expect to include 50 patients per year with an overall study duration of 5 years.
|
Randomised Controlled | None | Oxybutynine: 5 mg twice a day Venlafaxine: 37.5 mg once daily during one week, then dose increase to 75mg once daily |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- In order to be eligible to participate in this study, a subject must meet all of the following criteria: - Pre-, peri- or postmenopausal women of 18 years or above; - Indication for endocrine therapy and already started with tamoxifen, aromatase inhibitors or luteinizing hormone-releasing hormone analogues for at least 4 weeks and planning to continue for the duration of the study; - Experiencing hot flashes with a minimum of 14 per week for at least 1 month and desire to start a pharmacologic intervention.
Exclusion criteria 1
- A potential subject who meets any of the following criteria will be excluded from participation in this study: - Pregnant; - Breast feeding; - Patients who receive chemotherapy or immunotherapy/HER2 antibodies within the prior 8 weeks, and patients scheduled for chemotherapy during the study period; - Palliative setting; - Use of venlafaxine or any other antidepressants, also including St. John's wort within the previous year; - Creatinine clearance < 30 ml/min; - Liver cirrhosis; - Use of gabapentin and/or calcium channel antagonists within 2 weeks of study entry; - Use of oxybutynin before study entry; - Use of any other substances or therapies for the treatment of hot flashes, for instance acupuncture.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number and severity of hot flashes during 6-week therapy measured by the Hot Flash Diary on a daily basis.
Secondary endpoints 1
- Adverse events, sleep quality, quality of life, health status, anxiety and depression, cognitive function, sexual function, personal preference, adherence
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
SUB09558MIG · Substance
- Active substance
- Oxybutynin
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 10 mg milligram(s)
- Max total dose
- 20 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB00034MIG · Substance
- Active substance
- Venlafaxine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 37.5 mg milligram(s)
- Max total dose
- 375 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB00034MIG · Substance
- Active substance
- Venlafaxine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 75 mg milligram(s)
- Max total dose
- 375 mg milligram(s)
- Max treatment duration
- 6 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 9
SUB13933MIG · Substance
- Active substance
- Fulvestrant
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 500 mg milligram(s)
- Max total dose
- 500 mg/h milligram(s)/hour
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08444MIG · Substance
- Active substance
- Letrozole
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 2.5 mg milligram(s)
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10825MIG · Substance
- Active substance
- Tamoxifen
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 40 mg milligram(s)
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08449MIG · Substance
- Active substance
- Leuprorelin
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 11.25 mg milligram(s)
- Max total dose
- 11.25 mg milligram(s)
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08449MIG · Substance
- Active substance
- Leuprorelin
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 3.75 mg milligram(s)
- Max total dose
- 3.75 mg milligram(s)
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB05502MIG · Substance
- Active substance
- Anastrozole
- Pharmaceutical form
- FILM COATED TABLETS
- Route of administration
- ORAL USE
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 1 mg milligram(s)
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07492MIG · Substance
- Active substance
- Exemestane
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 25 mg milligram(s)
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07962MIG · Substance
- Active substance
- Goserelin
- Pharmaceutical form
- IMPLANT
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 3.6 mg milligram(s)
- Max total dose
- 3.6 mg milligram(s)
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07962MIG · Substance
- Active substance
- Goserelin
- Pharmaceutical form
- IMPLANT
- Route of administration
- SOLUTION FOR INJECTION
- Max daily dose
- 10.8 mg milligram(s)
- Max total dose
- 10.8 mg milligram(s)
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Reinier de Graaf Groep
- Sponsor organisation
- Reinier de Graaf Groep
- Address
- Reinier De Graafweg 5
- City
- Delft
- Postcode
- 2625 AD
- Country
- Netherlands
Scientific contact point
- Organisation
- Reinier de Graaf Groep
- Contact name
- Maaike de Leeuw
Public contact point
- Organisation
- Reinier de Graaf Groep
- Contact name
- Maaike de Leeuw
Locations
1 EU/EEA country · 4 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Netherlands | Ongoing, recruiting | 67 | 4 |
| Rest of world | — | 0 | — |
Investigational sites
Haga Hospital
Oncology, Els Borst-Eilersplein 275, 2545 AA, 's-Gravenhage
Reinier de Graaf Groep
Oncology, Reinier De Graafweg 5, 2625 AD, Delft
Alexander Monro Ziekenhuis Stichting
Oncology, Professor Bronkhorstlaan 10 G 94, 3723 MB, Bilthoven
Leids Universitair Medisch Centrum (LUMC)
Oncology, Albinusdreef 2, 2333 ZA, Leiden
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 |
|---|---|---|---|---|---|
| Netherlands | 2024-08-09 | 2024-10-03 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 8 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol RED FLASH study 2023-507847-13-00 for publication V1 20231009 | 4 |
| Protocol (for publication) | D4_patient_facing_documents EU CT 2023-507847-13-00 for publication | 2 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements EU CT number 2023-507847-13-00 | 1 |
| Subject information and informed consent form (for publication) | L1_CIS and ICF RED FLASH study for publication V4 20250401 | 4 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC oxybutynine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC venlafaxine | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis_ENG EU CT number 2023-507847-13-00 | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol_synopsis_Dutch EU CT number 2023-507847-13-00 | 2 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-12-22 | Netherlands | Acceptable 2024-04-09
|
2024-04-09 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-12-15 | Netherlands | Acceptable 2026-02-16
|
2026-02-16 |