Overview
Sponsor-declared trial summary
Phase
Therapeutic use (Phase IV)
Status
Authorised, recruitment pending
Participants planned
200
Countries
1
Sites
1
Breast cancer female NOS
To measure cytotoxic drugs, i.e., epirubicin, cyclophosphamide, docetaxel, paclitaxel and doxorubicin, used in routine treatment of breast cancer, and to search for correlations between exposure (AUC) and side effects. The intention is to offer future patients individualized dose adjustments to avoid both over- and und…
Key facts
- Sponsor
- Karolinska Institutet
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-08-28
- Transition trial
- Yes
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
External identifiers
- EU CT number
- 2024-514818-12-00
- EudraCT number
- 2017-000641-44
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Dose response, Safety, Pharmacokinetic, Pharmacodynamic, Efficacy
To measure cytotoxic drugs, i.e., epirubicin, cyclophosphamide, docetaxel, paclitaxel and doxorubicin, used in routine treatment of breast cancer, and to search for correlations between exposure (AUC) and side effects. The intention is to offer future patients individualized dose adjustments to avoid both over- and under-treatment.
Secondary objectives 14
- What correlations can be identified between exposure (AUC) and; hematologic-, liver-, cardiac- and ovarian toxicity?
- What correlations can be identified between exposure (AUC) and the patients’ quality of life?
- To what extent can genetic predispositions for drug metabolism be used to identify patients at increased risk of under- or overdose?
- What correlations can be identified between exposure (AUC) and tumor response in patients receiving neo-adjuvant treatment?
- What correlations can be identified between; BMI, age, smoking habits and renal status vs. exposure (AUC)?
- Can we identify any relationship between drug exposure (AUC) and; medical care needs, level of employment and time for recovery?
- Is there a difference in total and recurrence-free survival, between patients with low compared to medium or high exposure (AUC)?
- Is there a difference in the prevalence of severe adverse events in patients’ with high compared to low exposure (AUC)?
- Is the dose measurement in capillary blood samples equal or comparable to venous blood samples?
- What correlations between exposure (AUC) and circulating extracellular vesicles can be identified?
- What correlations between exposure (AUC) and health state utility values can be identified?
- Is there a difference in health care costs associated with severe adverse events in patients exhibiting high exposure compared to those with low exposure (AUC)?
- Is capillary self-sampling using the True Dose microsampling method feasible and capable of producing analyzable, high-quality samples for TDM in patients with breast cancer?
- Is self-collection using the microsampling devices acceptable, usable, and feasible from the participant's perspective?
Conditions and MedDRA coding
Breast cancer female NOS
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 3
- Female patients aged ≥ 18 years.
- Treated with any, or a combination, of the drugs cyclophosphamide, epirubicin, doxorubicin, docetaxel and paclitaxel.
- Written informed consent.
Exclusion criteria 4
- Patients fulfilling any of the contraindications mentioned for the studied drugs.
- Patients treated with a combinatorial regime of docetaxel, carboplatin and trastuzumab.
- Patients receiving palliative chemotherapy.
- Patients included in other clinical studies receiving not approved investigational medicinal drug.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint is to measure the incidence of grade 1-2 anemia (as defined by CTC v.4) in two exposure groups; high and low, in patients treated with EPI and CPA.
Secondary endpoints 14
- What correlations can be identified between exposure (AUC) and; hematologic-, liver-, cardiac- and ovarian toxicity?
- What correlations can be identified between exposure (AUC) and the patients’ quality of life?
- To what extent can genetic predispositions for drug metabolism be used to identify patients at increased risk of under- or overdose?
- What correlations can be identified between exposure (AUC) and tumor response in patients receiving neo-adjuvant treatment?
- What correlations can be identified between; BMI, age, smoking habits and renal status vs. exposure (AUC)?
- Can we identify any relationship between drug exposure (AUC) and; medical care needs, level of employment and time for recovery?
- Is there a difference in total and recurrence-free survival, between patients with low compared to medium or high exposure (AUC)?
- Is there a difference in the prevalence of severe adverse events in patients’ with high compared to low exposure (AUC)?
- Is the dose measurement in capillary blood samples equal or comparable to venous blood samples?
- What correlations between exposure (AUC) and circulating extracellular vesicles can be identified?
- What correlations between exposure (AUC) and health state utility values can be identified?
- Is there a difference in health care costs associated with severe adverse events in patients exhibiting high exposure compared to those with low exposure (AUC)?
- Capillary self-sampling success and sample quality rate.
- Usability and acceptability of microsampling devices based on patient feedback: Usability Questionnaire.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 5
Paclitaxel Accord 6 mg/ml koncentrat till infusionsvätska, lösning
PRD2002561 · Product
- Active substance
- Paclitaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 1 mg/m2 milligram(s)/square meter
- Max total dose
- 80 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- 27782
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Doxorubicin Accord 2 mg/ml koncentrat till infusionsvätska, lösning
PRD379848 · Product
- Active substance
- Doxorubicin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 1 mg/m2 milligram(s)/square meter
- Max total dose
- 550 mg milligram(s)
- Max treatment duration
- 19 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01DB01 — DOXORUBICIN
- Marketing authorisation
- 28126
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Docetaxel Ebewe 10 mg/ml koncentrat till infusionsvätska, lösning
PRD770610 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 1 mg/m2 milligram(s)/sq. meter
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 3 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- 28094
- MA holder
- EBEWE PHARMA
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sendoxan pulver till injektionsvätska, lösning
PRD349938 · Product
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INFUSION
- Max daily dose
- 1 mg/m2 milligram(s)/square meter
- Max total dose
- 2000 mg milligram(s)
- Max treatment duration
- 19 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01AA01 — CYCLOPHOSPHAMIDE
- Marketing authorisation
- 5866
- MA holder
- BAXTER MEDICAL AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Epirubicin Accord 2 mg/ml injektions-/infusionsvätska, lösning
PRD372778 · Product
- Active substance
- Epirubicin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 1 mg/m2 milligram(s)/square meter
- Max total dose
- 550 mg milligram(s)
- Max treatment duration
- 19 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01DB03 — EPIRUBICIN
- Marketing authorisation
- 25493
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska Institutet
- Sponsor organisation
- Karolinska Institutet
- Address
- Nobels Vag 6
- City
- Solna
- Postcode
- 171 65
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska Institutet
- Contact name
- Elham Hedayati
Public contact point
- Organisation
- Karolinska Institutet
- Contact name
- Elham Hedayati
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Authorised, recruitment pending | 200 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 27 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol TailorDose-II Track Changes v2point3 02 Feb 2026-signed | 1 |
| Protocol (for publication) | D1Protocol TailorDose-II -Clean- v2point3 - 02 Feb 2026-signed | 1 |
| Protocol (for publication) | TDII Subprotocol v 1 | 1 |
| Recruitment arrangements (for publication) | CTIS placeholder | 1 |
| Subject information and informed consent form - Extract (for publication) | Annex 1 Variable List KARDA Extraction | 1 |
| Subject information and informed consent form (for publication) | CLEAN Light forskningspersoninformation v3piont2 12 september 2025 | 3.2 |
| Subject information and informed consent form (for publication) | CLEAN Standard forskningspersoninformation v4point0 11th of September 2025 | 4.0 |
| Subject information and informed consent form (for publication) | L1_Participant Information Sheet Sweden Clean v3point3 date 29 Mars 2026-signed | 3.3 |
| Subject information and informed consent form (for publication) | L1_Participant Information Sheet Sweden Track Changes v3pint3 02 Feb 2026-signed | 1 |
| Subject information and informed consent form (for publication) | L1_Participant Information Sheet Sweden Tracked Changes v3point3 date 29 Mars 2026-signed | 3.3 |
| Subject information and informed consent form (for publication) | L1Participant Information Sheet Sweden -Clean- v3point3-02 Feb 2026-signed | 1 |
| Subject information and informed consent form (for publication) | Light forskningspersoninformation | 3.1 |
| Subject information and informed consent form (for publication) | PatientinfoTD20HRv1 | 1 |
| Subject information and informed consent form (for publication) | Standard forskningspersoninformation | 3.0 |
| Subject information and informed consent form (for publication) | Tracked Changes Light forskningspersoninformation v3point2 12 september 2025 | 3.2 |
| Subject information and informed consent form (for publication) | Tracked Changes Standard forskningspersoninformation v4point0 11th of September 2025 | 4.0 |
| Summary of Product Characteristics (SmPC) (for publication) | Produktresume Docetaxel | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Produktresume Doxorubicin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Produktresume Epirubicin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Produktresume Paclitaxel Accord | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Produktresume Sendoxan | 1 |
| Synopsis of the protocol (for publication) | Studieprotokoll Synopsis swedish | 1 |
| Synopsis of the protocol (for publication) | Studieprotokoll Synopsis swedish Clean | 1 |
| Synopsis of the protocol (for publication) | Studieprotokoll Synopsis swedish tracked changes | 1 |
| Synopsis of the protocol (for publication) | Study protocoll Synopsis Clean | 1 |
| Synopsis of the protocol (for publication) | Study protocoll Synopsis tracked changes | 1 |
| Synopsis of the protocol (for publication) | TDII Subprotocol Synopsis Swedish | 1 |
Application history
3 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-08-14 | Sweden | Acceptable with conditions 2024-08-27
|
2024-08-28 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-09-25 | Sweden | Acceptable with conditions | 2025-11-13 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2026-02-07 | Sweden | Acceptable 2026-03-23
|
2026-04-02 |