Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruitment ended
Participants planned
200
Countries
1
Sites
9
Primary breast cancer
Evaluate the impact of response-guided treatment on objective response and long-term outcome.
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
- 12 Nov 2014 → ongoing
- Decision date (initial)
- 2023-10-02
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-508411-23-00
- EudraCT number
- 2014-000808-10
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy, Pharmacogenomic, Pharmacogenetic, Others, Efficacy, Safety
Evaluate the impact of response-guided treatment on objective response and long-term outcome.
Secondary objectives 1
- Identify tumor characteristics and treatment-related changes of tumor biology predictive of long-term prognosis.
Conditions and MedDRA coding
Primary breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 21.1 | LLT | 10006191 | Breast cancer male NOS | 10029104 |
| 21.1 | LLT | 10006188 | Breast cancer female NOS | 10029104 |
| 20.0 | PT | 10006200 | Breast cancer stage II | 100000004864 |
| 20.0 | PT | 10006201 | Breast cancer stage III | 100000004864 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Written informed consent
- Patients with breast cancer confirmed by histology, characterized by immunohistochemistry for ER, PR, HER2 and proliferation marker
- Tumor and blood samples available. HER2 type confirmed by genomic profiling using Next-Generation Sequencing.
- Age 18 years or older. Elderly patients in condition adequate for planned therapy
- Primary breast cancer >20mm in diameter and/or verified lymph node metastases
- Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders
- LVEF >55%
- ECOG performance status 0-1
- Primary breast cancer as defined in p. 5 plus at most 2 morphologically characterized well-defined distant metastases accessible for stereotactic radiotherapy, provided that this treatment is available.
Exclusion criteria 5
- Distant metastases, including node metastases in the contralateral thoracic region or in the mediastinum
- Other malignancy diagnosed within the last five years, except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix
- Patients in child-bearing age without adequate contraception
- Pregnancy or lactation
- Uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Pathological objective response to primary medical treatment
Secondary endpoints 6
- Clinical/radiological objective response during neoadjuvant treatment
- Morphological, functional and biological characteristics of tumors exposed to cytotoxic and targeted treatment of early breast cancer
- Event-free survival (EFS), invasive disease-free survival (IDFS), distant disease-free survival (DDFS), breast cancer-specific survival (BCSS) and overall survival (OS)
- Safety
- Quality of life
- Frequency of breast-conserving surgery
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
Kadcyla 100 mg powder for concentrate for solution for infusion.
PRD2154039 · Product
- Active substance
- Trastuzumab Emtansine
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 3.6 mg/kg milligram(s)/kilogram
- Max total dose
- 3.6 mg/kg milligram(s)/kilogram
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01FD03 — -
- Marketing authorisation
- EU/1/13/885/001
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 3
Perjeta 420 mg concentrate for solution for infusion
PRD2154581 · Product
- Active substance
- Pertuzumab
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 840 mg milligram(s)
- Max total dose
- 840 mg milligram(s)
- Max treatment duration
- 15 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
Herceptin 600 mg solution for injection in vial
PRD2154036 · Product
- Active substance
- Trastuzumab
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XC03 — TRASTUZUMAB
- Marketing authorisation
- EU/1/00/145/002
- MA holder
- ROCHE REGISTRATION GMBH
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Docetaxel Accord 20 mg/1 ml concentrate for solution for infusion
PRD3445550 · Product
- Active substance
- Docetaxel
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS USE
- Max daily dose
- 100 mg/m2 milligram(s)/square meter
- Max total dose
- 100 mg/m2 milligram(s)/square meter
- Max treatment duration
- 15 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01CD02 — DOCETAXEL
- Marketing authorisation
- EU/1/12/769/001
- MA holder
- ACCORD HEALTHCARE S.L.U.
- MA country
- Liechtenstein
- 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
- Thomas Hatschek
Public contact point
- Organisation
- Karolinska University Hospital
- Contact name
- Thomas Hatschek
Locations
1 EU/EEA country · 9 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Sweden | Ongoing, recruitment ended | 200 | 9 |
| Rest of world | — | 0 | — |
Investigational sites
Norrlands University Hospital
Cencercenter, Klintvagen 10, Alidhem, Umea
Sahlgrenska University Hospital-Vastra Gotalandsregionen
Oncology, Bla Straket 5, 413 46, Goteborg
Uppsala University Hospital
Oncology, Dag Hammarskjolds Vag 20, Uppsala Domkyrkofors., Uppsala
Karolinska University Hospital
Oncology, Eugeniavagen 3, 171 64, Solna
Soedersjukhuset AB
Oncology, Sjukhusbacken 10, Hogalid, Stockholm
Region Skane Skanes Universitetssjukhus
Oncology, Entregatan 7, 222 42, Lund
Capio S:t Goerans Sjukhus AB
Oncology, Sankt Goransplan 1, Vastermalm, Stockholm
Region Vaesternorrland
Oncology, Lasarettsvagen 21, 856 43, Sundsvall
Region Oerebro Laen
Oncology, Sodra Grev Rosengatan, 701 85, Orebro
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 |
|---|---|---|---|---|---|
| Sweden | 2014-11-12 | 2014-12-15 | 2018-10-10 |
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 ver6 2023-508411-23-00 | 6.0 |
| Protocol (for publication) | D1 Protocol ver6 2023-508411-23-00 tc | 6.0 |
| Protocol (for publication) | D1 Protocol ver601 2023-508411-23-00 | 6.01 |
| Protocol (for publication) | D1 Protocol ver601 2023-508411-23-00 tc | 6.01 |
| Protocol (for publication) | Protocol 2023-508411-23-00 | 5.0 |
| Recruitment arrangements (for publication) | Blank document | 1 |
| Subject information and informed consent form (for publication) | SIS and IFC Sweden | 1 |
| Synopsis of the protocol (for publication) | D1 Protocol synopsis 2023-508411-23-00 | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-09-25 | Sweden | Acceptable 2023-10-02
|
2023-10-02 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2025-09-08 | Sweden | Acceptable 2025-11-17
|
2025-11-17 |