Overview
Sponsor-declared trial summary
breast cancer
To find out whether addition of pertuzumab to an adjuvant regimen containing trastuzumab and chemotherapy improves invasive disease-free survival in patients with HER2-positive early breast cancer
Key facts
- Sponsor
- HUS-Yhtymae
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2024-04-25
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- Cancer Society of Finland
External identifiers
- EU CT number
- 2024-512884-30-00
- EudraCT number
- 2015-002323-25
- ClinicalTrials.gov
- NCT02625441
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To find out whether addition of pertuzumab to an adjuvant regimen containing trastuzumab and chemotherapy improves invasive disease-free survival in patients with HER2-positive early breast cancer
Secondary objectives 1
- To investigate whether adding pertuzumab to the adjuvant treatment regimen improves overall survival
Conditions and MedDRA coding
breast cancer
Study design 1 period
| # | Title | Allocation | Blinding | Roles blinded | Arms |
|---|---|---|---|---|---|
| 1 | Randomization phase The study participants are allocated into 2 groups based on computerized random allocation.
|
Randomised Controlled | None | Arm A: Trastuzumab plus pertuzumab plus docetaxel (3 cycles) (HPT) followed by three 3-weekly cycles of FEC Arm B: Weekly or 3-weekly trastuzumab plus pertuzumab plus 3-weekly docetaxel (3 cycles) (HPT) followed by three 3-weekly cycles of FEC, followed by single-agent trastuzumab to complete 1 year of trastuzumab administration |
Regulatory references
- Scientific advice from competent authorities
- HUS-Yhtymae
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 1
- Woman > 18 years of age, confirmed invasive HER2-positive breast cancer
Exclusion criteria 1
- Presence of distant metastases, clinically significant cardiac disease
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Invasive disease-free survival
Secondary endpoints 1
- Overall survival; Distant disease-free survival; Left ventricle ejection fractions; Adverse event rate; Quality of life
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB16455MIG · Substance
- Active substance
- Pertuzumab
- Pharmaceutical form
- CONCENTRATE FOR SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 840 mg milligram(s)
- Max total dose
- 1680 mg milligram(s)
- Max treatment duration
- 9 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
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
- 1680 mg milligram(s)
- Max treatment duration
- 9 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
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
HUS-Yhtymae
- Sponsor organisation
- HUS-Yhtymae
- Address
- Paciuksenkatu 3
- City
- Helsinki
- Postcode
- 00290
- Country
- Finland
Scientific contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Heikki Joensuu
Public contact point
- Organisation
- HUS-Yhtymae
- Contact name
- Heikki Joensuu
Locations
2 EU/EEA countries · 6 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Finland | Authorised, recruitment pending | 470 | 5 |
| Sweden | Authorised, recruitment pending | 50 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-29 | Finland | Acceptable 2024-04-25
|
2024-04-25 |