Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
402
Countries
3
Sites
23
Non-metastatic HER2-positive Breast Cancer
To compare, in terms of locally assessed pathologic complete remission (pCR) rates, standard neoadjuvant therapy versus trastuzumab deruxtecan (T-DXd) followed by taxane and dual HER2 blockade (THP) in patients with molecularly Human Epidermal Growth Factor Receptor 2 (HER2)-enriched and clinically HER2-positive, non-m…
Key facts
- Sponsor
- Karolinska University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 23 Jun 2023 → ongoing
- Decision date (initial)
- 2025-08-18
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Veracyte · Novartis · AstraZeneca · Vetenskapsrådet
External identifiers
- EU CT number
- 2022-501504-95-00
- ClinicalTrials.gov
- NCT05900206
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To compare, in terms of locally assessed pathologic complete remission (pCR) rates, standard neoadjuvant therapy versus trastuzumab deruxtecan (T-DXd) followed by taxane and dual HER2 blockade (THP) in patients with molecularly Human Epidermal Growth Factor Receptor 2 (HER2)-enriched and clinically HER2-positive, non-metastatic breast cancer (BC).
Secondary objectives 7
- To perform translational studies on clinicopathologic factors and the tissues or peripheral blood for the discovery of prognostic or predictive biomarkers which are relevant to the treatments in the trial.
- To compare, in terms of locally assessed pCR rates, the two patient groups of the initial randomization of molecularly unselected patients between standard and experimental therapy, regardless of administered therapy beyond cycle 3
- To investigate the pCR rates for patients with HER2-positive, but non-HER2-enriched BC, who will receive sequential combinations of T-DXd and either ribociclib combined with endocrine therapy and dual HER2-blockade for Estrogen Receptor (ER) positive and molecularly luminal cancers (de-escalated, chemotherapy-free regimen) or response-adjusted therapy for basal-like or ER-negative and luminal cancers (escalated therapy).
- Efficacy measures for the comparison of standard and experimental treatment, both time-to-event (relapse-free, distant disease-free and overall survival) and short-term endpoints (pathologic response according to residual cancer burden [RCB], objective response rate
- To evaluate the effect of standard and experimental treatment in the type of surgery performed in the breast and the axilla
- To evaluate patient reported outcomes (PRO) measures for health-related quality of life in the two treatment arms.
- To evaluate the safety and tolerability of the two treatments arms
Conditions and MedDRA coding
Non-metastatic HER2-positive Breast Cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 23.0 | PT | 10065430 | HER2 positive breast cancer | 100000004864 |
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2023-505249-24-00 | Phase III Study of Trastuzumab Deruxtecan (T-DXd) with or without Pertuzumab versus Taxane, Trastuzumab and Pertuzumab in HER2-positive, First-line Metastatic Breast Cancer (DESTINY-Breast09) | AstraZeneca AB |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 12
- Women or men 18 years or older
- Written informed consent must be given according to ICH/GCP, and national/local regulations
- Histologically confirmed breast cancer with an invasive component measuring > 20 mm and/or with morphologically confirmed spread to regional lymph nodes (stage cT2-cT4 with any cN, or cN1-cN3 with cT1-4). Ipsilateral multifocal and multicentric tumors are allowed if they fulfill inclusion criterion 6.
- Performance status 0 or 1 at the time of randomisation
- Known estrogen-receptor and/or progesterone receptor status, as assessed locally by IHC. The cut-off for positivity for ER/PR for this study is at least 10% of cell nuclei staining for ER or PR, respectively
- Known HER2-positive breast cancer defined as an IHC status of 3+. If IHC is 2+, a positive in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing. ISH positivity is defined as a ratio of ≥ 2 for the number of HER2 gene copies to the number of signals for chromosome 17 copies.
- Left Ventricular Ejection Fraction (LVEF) ≥ 50% within 28 days before randomization
- Adequate bone-marrow, hepatic and renal function
- Availability of tumor and blood samples as described in the protocol
- Negative serum pregnancy test for women of childbearing potential or for patients who have experienced menopause onset <12 months prior to randomisation
- Patients of childbearing potential must be willing to use one highly effective contraception or two effective forms of nonhormonal contraception.
- Participants must be able to communicate with the investigator and comply with the requirements of the study procedures
Exclusion criteria 24
- Participation in other interventional trials
- Concomitant medication(s) with a known risk to prolong the QT interval
- Pregnant or breastfeeding female patients, or patients who are planning to become pregnant
- History of (non-infectious) Interstitial Lung Disease (ILD) / pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
- Lung-specific intercurrent clinically significant illnesses including, but not limited to, any underlying pulmonary disorder (e.g. pulmonary emboli within three months of the study enrollment, severe asthma, severe COPD, restrictive lung disease, pleural effusion etc.)
- Any autoimmune, connective tissue or inflammatory disorders (e.g. Rheumatoid arthritis, Sjogren's, sarcoidosis etc.) where there is documented, or a suspicion of pulmonary involvement at the time of screening. Full details of the disorder should be recorded in the eCRF for patients who are included in the study.
- Prior pneumonectomy
- History of positive testing for HIV or known AIDS
- Acute or chronic infection with hepatitis B or C virus. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA
- Any impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., uncontrolled ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- Receipt of live, attenuated vaccine within 30 days prior to the first dose of trastuzumab deruxtecan. Note: Patients, if enrolled, should not receive live vaccine during the study and up to 30 days after the last dose of study drug
- Pre-treatment axillary surgery
- Any psychological, including substance abuse, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
- Allergic reactions or hypersensitivity to the study drugs or other monoclonal antibodies
- Administration of other experimental drugs, either concomitantly or during the past 30 days before treatment initiation
- A pleural effusion, ascites or pericardial effusion that requires drainage, peritoneal shunt, or Cell-free and Concentrated Ascites Reinfusion Therapy (CART).
- Recent major surgery
- Known presence of distant metastases, including node metastases in the contralateral thoracic region or in the mediastinum. Synchronous contralateral breast cancer is allowed if the tumor is HER2 positive according to the definition of inclusion criterion 6.
- Other malignancy diagnosed during the past five years
- History of invasive breast cancer
- History of DCIS, except for patients treated exclusively with mastectomy >5 years prior to diagnosis of current breast cancer
- Active cardiac disease or a history of cardiac dysfunction
- Patients with ER-positive breast cancer being treated with drugs recognized as strong inhibitors or inducers of the isoenzyme CYP3A which cannot be discontinued at least 7 days prior to planned treatment with ribociclib.
- Uncontrolled infection requiring systemic antibiotics, antivirals or antifungals
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Locally assessed rate of pCR at the molecularly HER2-enriched population, defined as ypT0/Tis, ypN0, as determined at the surgical specimen by a pathologist blinded to treatment assignment (intention-to-treat analysis).
Secondary endpoints 19
- Locally assessed rate of pCR, defined as ypT0/Tis, ypN0, at the two patient groups of the initial randomization of TCHP versus T-DXd, regardless of administered therapy after cycle 3
- Locally assessed rate of pCR at ER-positive and luminal subgroup
- Locally assessed rate of pCR at ER-negative and luminal subgroup, at the basal-like subgroup and the normal-like subgroup
- Locally assessed rate of pCR at all molecular subgroups in the evaluable population
- Rates of radiologic complete response after three courses of either standard therapy or T-DXd
- Overall survival (OS), defined as time from randomization to death by any cause, for each molecular group, including the comparison of TCHP versus T-DXd -> THP in HER2-enriched patients, and at the two patient groups of the initial randomization of TCHP versus T-DXd
- Distant relapse-free survival (DRFS), defined as time from randomization to distant metastases or death by any cause, for each molecular group, including the comparison of TCHP versus T-DXd -> THP in HER2-enriched patients, and at the two patient groups of the initial randomization of TCHP versus T-DXd
- Event-free survival (EFS), defined as time from randomization to disease progression, breast cancer relapse, contralateral breast cancer, other malignant neoplasms, or death by any cause, for each molecular group, including the comparison of TCHP versus T-DXd -> THP in HER2-enriched patients, and at the two patient groups of the initial randomization of TCHP versus T-DXd
- Rates of complete radiologic response, for each molecular group, including the comparison of TCHP versus T-DXd -> THP in HER2-enriched patients, and at the two patient groups of the initial randomization of TCHP versus T-DXd
- Pathologic response according to Residual Cancer Burden Class, as described in 1, 2, for each molecular group, including the comparison of TCHP versus T-DXd -> THP in HER2-enriched patients, and at the two patient groups of the initial randomization of TCHP versus T-DXd
- Rate of breast conserving surgery, for each molecular group, including the comparison of TCHP versus T-DXd in HER2-enriched patients, and at the two patient groups of the initial randomization of TCHP versus T-DXd
- Rate of de-escalation of breast surgery (conversion from mastectomy to breast conserving surgery or de-escalation of complexity from an oncoplastic breast-conserving procedure to simple wide local excisions) for each molecular group, including the comparison of TCHP versus T-DXd -> THP in HER2-enriched patients, and at the two patient groups of the initial randomization of TCHP versus T-DXd
- Rate of Sentinel Lymph Node Dissection (SLND), for each molecular group, including the comparison of TCHP versus T-DXd -> THP in HER2-enriched patients, and at the two patient groups of the initial randomization of TCHP versus T-DXd
- Rate of de-escalation of axillary surgery (conversion from axillary lymph node dissection to either targeted axillary dissection or sentinel lymph node dissection) for each molecular group, including the comparison of TCHP versus T-DXd in HER2-enriched patients, and at the two patient groups of the initial randomization of TCHP versus T-DXd.
- Rate of Sentinel Lymph Node detection, Targeted Axillary Dissection success and false-negative rates of these procedures in initially node-positive patients for each molecular group, including the comparison of TCHP versus T-DXd in HER2-enriched patients, and at the two patient groups of the initial randomization of TCHP versus T-DXd
- Frequency and grade of adverse events (AE) (according to NCI CTCAE v. 5.0, see https://ctep.cancer.gov/protocolDevelopment/electronic_applications/docs/CTCAE_v5_Quick_Reference_5x7.pdf) and rate of discontinuation due to toxicity
- PRO endpoints including health related quality of life scores [European Organization for Research and Treatment of Cancer Quality of Life Instrument (EORTC QLQ-C30); European Organization for Research and Treatment of Cancer Breast Cancer Module (EORTC QLQ-BR23)].
- Exploratory analyses of clinicopathologic characteristics as predictors for response
- Discovery of biomarkers of response/resistance to administered neoadjuvant therapy at the protein, RNA and DNA levels in both tumor tissue and blood/plasma, as described in detail in protocol section 9.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Kisqali 200 mg film‑coated tablets
PRD5341538 · Product
- Active substance
- Ribociclib
- Substance synonyms
- LEE011
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 25200 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EF02 — -
- Marketing authorisation
- EU/1/17/1221/001
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Enhertu 100 mg powder for concentrate for solution for infusion
PRD8681525 · Product
- Active substance
- Trastuzumab Deruxtecan
- Substance synonyms
- DS-8201, DS-8201A
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS INFUSION
- Max daily dose
- 5.8 mg/Kg milligram(s)/kilogram
- Max total dose
- 32.4 mg/Kg milligram(s)/kilogram
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FD04 — -
- Marketing authorisation
- EU/1/20/1508/001
- MA holder
- DAIICHI SANKYO EUROPE GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 11
Perjeta 420 mg concentrate for solution for infusion
PRD2154581 · Product
- Active substance
- Pertuzumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 840 mg milligram(s)
- Max total dose
- 2940 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XC13 — -
- Marketing authorisation
- EU/1/13/813/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Carboplatin Accord 10 mg/ml koncentrat till infusionsvätska, lösning
PRD2005430 · Product
- Active substance
- Carboplatin
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 5 Other
- Max total dose
- 30 Other
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XA02 — CARBOPLATIN
- Marketing authorisation
- 25512
- MA holder
- ACCORD HEALTHCARE B.V.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Epirubicin Accord 2 mg/ml injektions-/infusionsvätska, lösning
PRD1958920 · Product
- Active substance
- Epirubicin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 90 mg/m2 milligram(s)/sq. meter
- Max total dose
- 360 mg/m2 milligram(s)/square meter
- Max treatment duration
- 8 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
Letrozole Bluefish 2,5 mg filmdragerade tabletter
PRD351584 · Product
- Active substance
- Letrozole
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 105 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02BG04 — LETROZOLE
- Marketing authorisation
- 41717
- MA holder
- BLUEFISH PHARMACEUTICALS AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Phesgo 600 mg/600 mg solution for injection
PRD8601830 · Product
- Active substance
- Trastuzumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 3600 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XY02 — -
- Marketing authorisation
- EU/1/20/1497/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Phesgo 1200 mg/600 mg solution for injection
PRD8600161 · Product
- Active substance
- Trastuzumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 1200 mg milligram(s)
- Max total dose
- 1200 mg milligram(s)
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01XY02 — -
- Marketing authorisation
- EU/1/20/1497/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Docetaxel Accord 80 mg/4 ml concentrate for solution for infusion
PRD3445553 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 600 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- EU/1/12/769/002
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Liechtenstein
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Paclitaxel Actavis 6 mg/ml koncentrat till infusionsvätska, lösning.
PRD928325 · Product
- Active substance
- Paclitaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 80 mg/m2 milligram(s)/sq. meter
- Max total dose
- 960 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD01 — PACLITAXEL
- Marketing authorisation
- 24615
- MA holder
- ACTAVIS GROUP PTC EHF.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sendoxan pulver till injektionsvätska, lösning
PRD349939 · Product
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 600 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2400 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 8 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
Goserelin UAB Boston Biopharma LT 3.6 mg implant, in a pre-filled syringe
PRD9484078 · Product
- Active substance
- Goserelin
- Pharmaceutical form
- IMPLANT IN PRE-FILLED SYRINGE
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 3.6 mg milligram(s)
- Max total dose
- 7.2 mg milligram(s)
- Max treatment duration
- 8 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02AE03 — GOSERELIN
- Marketing authorisation
- MA1480/00101
- MA holder
- UAB BOSTON BIOPHARMA LT
- MA country
- Malta
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Herceptin 150 mg powder for concentrate for solution for infusion
PRD2154035 · Product
- Active substance
- Trastuzumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 8 mg/kg milligram(s)/kilogram
- Max total dose
- 38 mg/kg milligram(s)/kilogram
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XC03 — TRASTUZUMAB
- Marketing authorisation
- EU/1/00/145/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 9
Dexamethasone Orifarm 4 mg tabletter
PRD10257257 · Product
- Active substance
- Dexamethasone
- Substance synonyms
- DEXAMETASONE, DEXAMETHASONUM
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL AND IV
- Max daily dose
- 16 mg milligram(s)
- Max total dose
- 336 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- 21-14352
- MA holder
- ORIFARM HEALTHCARE A/S
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Palonosetron Fresenius Kabi 250 mikrogram injektionsvätska, lösning
PRD9366594 · Product
- Active substance
- Palonosetron Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 250 µg microgram(s)
- Max total dose
- 1750 µg microgram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- A04AA05 — -
- Marketing authorisation
- 33395
- MA holder
- FRESENIUS KABI AB
- MA country
- Finland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
EMEND 125 mg+80 mg hard capsules
PRD6279072 · Product
- Active substance
- Aprepitant
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 125 mg milligram(s)
- Max total dose
- 1995 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- A04AD12 — -
- Marketing authorisation
- EU/1/03/262/006
- MA holder
- MERCK SHARP & DOHME BV
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Metoclopramide ”Orifarm”, tabletter
PRD1914329 · Product
- Active substance
- Metoclopramide Hydrochloride Anhydrous
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 30 mg milligram(s)
- Max total dose
- 1470 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- A03FA01 — METOCLOPRAMIDE
- Marketing authorisation
- 52211
- MA holder
- ORIFARM GENERICS A/S
- MA country
- Denmark
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Zarzio 48 MU/0.5 ml solution for injection or infusion in pre-filled syringe
PRD6059198 · Product
- Active substance
- Filgrastim
- Substance synonyms
- FILGRASTIM (GENETICAL RECOMBINATION)
- Pharmaceutical form
- SOLUTION FOR INJECTION/INFUSION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 48 Other
- Max total dose
- 2352 Other
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L03AA02 — FILGRASTIM
- Marketing authorisation
- EU/1/08/495/005
- MA holder
- SANDOZ GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Ondansetron Bluefish 8 mg munsönderfallande tabletter
PRD373838 · Product
- Active substance
- Ondansetron
- Pharmaceutical form
- ORODISPERSIBLE TABLET
- Route of administration
- ORAL
- Max daily dose
- 8 mg milligram(s)
- Max total dose
- 168 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- A04AA01 — ONDANSETRON
- Marketing authorisation
- 26390
- MA holder
- BLUEFISH PHARMACEUTICALS AB
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Neulasta 6 mg solution for injection
PRD373150 · Product
- Active substance
- Pegfilgrastim
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS INJECTION
- Max daily dose
- 6 mg milligram(s)
- Max total dose
- 42 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- L03AA13 — PEGFILGRASTIM
- Marketing authorisation
- EU/1/02/227/002
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD5586673 · Product
- Active substance
- Betamethasone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL AND IV
- Max daily dose
- 16 mg milligram(s)
- Max total dose
- 336 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- H02AB01 — BETAMETHASONE
- Marketing authorisation
- 6940
- MA holder
- ALFASIGMA S.P.A.
- MA country
- Sweden
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Olanzapine 5mg Film-coated Tablets
PRD10152317 · Product
- Active substance
- Olanzapine
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 5 mg milligram(s)
- Max total dose
- 175 mg milligram(s)
- Max treatment duration
- 18 Week(s)
- Authorisation status
- Authorised
- ATC code
- N05AH03 — OLANZAPINE
- Marketing authorisation
- PL 51463/0093
- MA holder
- KENT PHARMA UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Karolinska University Hospital
- Sponsor organisation
- Karolinska University Hospital
- Address
- Eugeniavagen 3
- City
- Solna
- Postcode
- 171 64
- Country
- Sweden
Scientific contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Theodoros Foukakis
Public contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Theodoros Foukakis
Locations
3 EU/EEA countries · 23 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Belgium | Authorised, recruitment pending | 32 | 4 |
| Norway | Ongoing, recruiting | 60 | 7 |
| Sweden | Ongoing, recruiting | 310 | 12 |
| Rest of world | — | 0 | — |
Investigational sites
Association Hospitaliere De Bruxelles Et De Schaerbeek Centre Hospitalier Universitaire Brugmann
Oncology, Arthur Van Gehuchtenplein 4, 1020, Brussels
Institut Jules Bordet
Medical Oncology, Mijlenmeersstraat 90, 1070, Anderlecht
UZ Leuven
General Oncology, Herestraat 49, 3000, Leuven
Ziekenhuis Aan De Stroom
Medical Oncology, Oosterveldlaan 24, 2610, Antwerp
St. Olavs Hospital HF
Cancer Clinic, Prinsesse Kristinas G. 3, 7030, Trondheim
Vestre Viken HF
Dept of Oncology, Groenland 32, 3045, Drammen
Nordlandssykehuset HF
Dept. of Oncology, Parkveien 95, 8005, Bodo
Helse Stavanger HF
Dept of Hematology and Oncology, Gerd-Ragna Bloch Thorsens Gate 8, 4011, Stavanger
Helse Moere Og Romsdal HF
oncology, Aasehaugen 1, 6017, Aalesund
Oslo University Hospital HF
Dept of Oncology, Taarnbygget, Kirkeveien 166, Oslo
Universitetssykehuset Nord-Norge HF
Department of Oncology, P. O. Box 100, 9038, Tromsoe
Norrlands University Hospital
Strålningsvetenskaper, onkologi, Umea Universitet, 901 85, Umea
Sahlgrenska University Hospital-Vaestra Goetalandsregionen
Onkologiska kliniken, Bla Straket 5, 413 46, Goteborg
Karolinska University Hospital
Bröstcentrum, ME BES, Tema Cancer, Eugeniavagen 3, 171 64, Solna
Malarsjukhuset Eskilstuna
Onkologkliniken, Kungsvagen 42, Tunafors, Eskilstuna
Sodra Alvsborg Hospital-Vastra Gotalandsregionen
Onkologiska kliniken, Bramhultsvagen 53, Boras Gustav Adolf, Boras
Region Vaesternorrland
Oncology, Lasarettsvagen 21, 856 43, Sundsvall
Region Orebro lan
Oncology, Sodra Grev Rosengatan, 701 85, Orebro
Soedersjukhuset AB
Oncology, Sjukhusbacken 10, Hogalid, Stockholm
Uppsala University Hospital
Blod- och Tumörsjukdomar, Sektionen för onkologi, Akademiska Sjukhuset, 751 85, Uppsala
Region Skane - Skanes Universitetssjukhus
Onkologens kliniska forskningsenhet, Fritz Bauers Gata 5, Malmo St. Johns, Malmo
Region Kronoberg
Oncology, Nygatan 20, Vaxjo Stads- Och Domkyrkofors., Vaxjo
Sankt Gorans Sjukhus
Oncology, Sankt Goransplan 1, Vastermalm, Stockholm
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 |
|---|---|---|---|---|---|
| Norway | 2025-05-20 | 2025-09-15 | |||
| Sweden | 2023-06-23 | 2023-10-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 42 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | ARIADNE protocol for publication | 3 |
| Protocol (for publication) | D1_Protocol ARIADNE 2022-501504-22-00 ver4 redacted | 4 |
| Protocol (for publication) | D4_Quality of life questionnaire FR | 1 |
| Protocol (for publication) | D4_Quality of life questionnaire NL | 1 |
| Protocol (for publication) | QoL Questionnaires English | 1 |
| Recruitment arrangements (for publication) | ARIADNE Rekrytering och samtyckesprocess SE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangements BE | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment Arrangements NO | 1 |
| Subject information and informed consent form (for publication) | ARIADNE Forskningspersonsinformation | 4.1 |
| Subject information and informed consent form (for publication) | ARIADNE Informed Consent Form | 4 |
| Subject information and informed consent form (for publication) | L1_ICF ARIADNE v4 sv tc | 4.1 |
| Subject information and informed consent form (for publication) | L1_ICF ARIADNE_version2-2_NO_tracked | 4 |
| Subject information and informed consent form (for publication) | L1_ICF_ARIADNE_VERSION 1 NO | 4 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF Dutch ARIADNE | 1 |
| Subject information and informed consent form (for publication) | L1_SIS-ICF French ARIADNE | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Carboplatin EMA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Cyclophosphamide SPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Docetaxel EMA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Enhertu EMA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Epirubicin SPC | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Goserelin svenska | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Herceptin EMA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Kisqali EMA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Letrozole EMA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Paclitaxel EMA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Perjeta EMA | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | Phesgo EMA | 1 |
| Synopsis of the protocol (for publication) | ARIADNE synopsis Norwegian | 1 |
| Synopsis of the protocol (for publication) | ARIADNE synopsis Swedish | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis DE 2022-501504-95-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis de BE 2022-501504-95-00 ver4 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis de BE 2022-501504-95-00 ver4 tc | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis FR 2022-501504-95-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis fr BE 2022-501504-95-00 ver4 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis fr BE 2022-501504-95-00 ver4 tc | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis NL 2022-501504-95-00 | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis nl BE 2022-501504-95-00 ver4 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis nl BE 2022-501504-95-00 ver4 tc | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis no 2022-501504-95-00 ver4 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis no 2022-501504-95-00 ver4 tc | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis sv 2022-501504-95-00 ver4 | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis sv 2022-501504-95-00 ver4 tc | 4 |
Application history
6 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2022-12-21 | Sweden | Acceptable 2023-04-18
|
2023-04-19 |
| 2 | SUBSTANTIAL MODIFICATION | SM-2 | 2024-02-20 | Sweden | Acceptable 2024-04-08
|
2024-04-09 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2024-05-03 | Sweden | Acceptable | 2024-07-04 |
| 4 | SUBSTANTIAL MODIFICATION | SM-6 | 2024-12-12 | Sweden | Acceptable 2025-02-12
|
2025-02-17 |
| 5 | SUBSEQUENT ADDITION OF MSC | APP-5 | 2025-07-11 | Acceptable 2025-02-12
|
2025-08-18 | |
| 6 | SUBSTANTIAL MODIFICATION | SM-7 | 2026-01-12 | Sweden | Acceptable 2026-03-13
|
2026-03-19 |