Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Ongoing, recruiting
Participants planned
400
Countries
1
Sites
1
Metastatic breast cancer
To compare progression-free-survival in the experimental group compared to standard chemotherapy
Key facts
- Sponsor
- Istituto Europeo Di Oncologia S.r.l.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 20 Sep 2019 → ongoing
- Decision date (initial)
- 2024-11-18
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Ministero della Salute and Fondazione AIRC per la Ricerca sul Cancro
External identifiers
- EU CT number
- 2024-513934-40-00
- EudraCT number
- 2017-003216-39
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To compare progression-free-survival in the experimental group compared to standard chemotherapy
Secondary objectives 6
- To compare overall survival
- To compare response rates
- To evaluate safety of the strategy as a whole
- To explore the efficacy (response rate, progression-free survival, overall survival) of the individual targeted agents.
- To correlate molecular mechanisms in patients with the efficacy endpoints (response rate, progression-free and overall survival)
- To investigate the additional molecular mechanisms in patients with tumor response versus patients without tumor response.
Conditions and MedDRA coding
Metastatic breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10006285 | Breast neoplasm NOS | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 13
- Signed informed consent form.
- Patients with histologically confirmed breast adenocarcinoma.
- Patients with documented presence of specific molecular alterations.
- Patient has radiologic evidence of inoperable locally advanced, or metastatic BC
- Presence of measurable lesions according to RECIST criteria v1.1. Lytic bone lesions or mixed lytic-blastic lesions , that can be evaluated by MRI , can be considered as measurable lesions.
- Presence of an accessible metastatic lesion for biopsy or at least one archived metastatic tumour sample collected no longer than 6 months earlier. For patients with only bone lesions the biopsy is not mandatory but an available tumor sample (including primitive tumor) is requested
- Age > 18 years
- PS 0/1
- Patients should have documented disease progression. There are not limits to previous systemic anticancer therapy for the metastatic or locally recurrent disease. Patients with HER2+ disease must have received 2 or more line of antiHER2 treatment (including dual blockade with pertuzumab/trastuzumab and T-DM1 or other anti HER2 agents that my impact OS).
- Life expectancy =3 months
- For women with childbearing potential, a negative pregnancy test within 14 days prior to initiation of the study drug.
- Ability to swallow oral capsules
- Ecocardiogramma normale al baseline ( LVEF >50% e SF >15%)
Exclusion criteria 4
- Patients with known or suspected brain metastases or spinal cord compression, unless the condition has been asymptomatic, has been treated with surgery and / or radiation, and has been stable without requiring corticosteroids nor anti-convulsant medications for at least 2 weeks prior to the first dose of study medication.
- History of clinically significant or uncontrolled cardiac disease
- Uncontrolled arterial hypertension
- Participation in another clinical study with an investigational product (IP) during the last 30 days
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- progression free-survival
Secondary endpoints 1
- Overall survival
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 3
CASODEX 50 mg compresse rivestite con film
PRD9232515 · Product
- Active substance
- Bicalutamide
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 18.25 g gram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- L02BB03 — BICALUTAMIDE
- Marketing authorisation
- 031113018
- MA holder
- LABORATOIRES JUVISE PHARMACEUTICALS
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32234 · Substance
- Active substance
- Olaparib
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL USE
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 219 g gram(s)
- Max treatment duration
- 12 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB32237 · Substance
- Active substance
- Selumetinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL USE
- Max daily dose
- 150 mg milligram(s)
- Max total dose
- 54.75 g gram(s)
- Max treatment duration
- 12 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
Istituto Europeo Di Oncologia S.r.l.
- Sponsor organisation
- Istituto Europeo Di Oncologia S.r.l.
- Address
- Via Giuseppe Ripamonti 435
- City
- Milan
- Postcode
- 20141
- Country
- Italy
Scientific contact point
- Organisation
- Istituto Europeo Di Oncologia S.r.l.
- Contact name
- Giuseppe Curigliano
Public contact point
- Organisation
- Istituto Europeo Di Oncologia S.r.l.
- Contact name
- Giuseppe Curigliano
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruiting | 400 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
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 |
|---|---|---|---|---|---|
| Italy | 2019-09-20 | 2019-09-26 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 4 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_protocol 2024-513934-40-00 | 3 |
| Recruitment arrangements (for publication) | Blank document | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF adults | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Casodex | 1 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-10-11 | Italy | Acceptable 2024-10-29
|
2024-11-18 |