Overview
Sponsor-declared trial summary
Phase
Therapeutic exploratory (Phase II)
Status
Authorised, recruitment pending
Participants planned
50
Countries
1
Sites
1
Symptomatic bone metastases from breast cancer
To evaluate efficacy and safety of Ra223 in monotherapy or in combination with aromatase inhibitors in patients with symptomatic bone metastases from breast cancer.
Key facts
- Sponsor
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Decision date (initial)
- 2026-06-08
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
- Funding sources
- ASSESSORATO DELLA SALUTE - REGIONE SICILIA
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Safety, Therapy, Efficacy
To evaluate efficacy and safety of Ra223 in monotherapy or in combination with aromatase inhibitors in patients with symptomatic bone metastases from breast cancer.
Secondary objectives 1
- to evaluate the tolerability of Ra223 in monotherapy or in combination with aromatase inhibitors in patients with symptomatic bone metastases from breast cancer
Conditions and MedDRA coding
Symptomatic bone metastases from breast cancer
| Version | Level | Code | Term | System organ class |
|---|---|---|---|---|
| 20.0 | LLT | 10005993 | Bone metastases | 10029104 |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 8
- Patients aged =/>18 years
- Histological confirmation of breast cancer
- Patients with predominant bone metastases with at least 2 skeletal metastases identified at baseline bone scan.
- The presence of metastases in soft tissues (skin, subcutaneous tissue, muscle fat, lymph nodes) is permitted;
- Performance Status (PS) < or equal to 2 of Eastern Cooperative Oncology Group (ECOG).
- Absolute neutrophil count ≥1,5 x 109/l
- Platelet count ≥100 x 109/l without platelet transfusion within 4 weeks before the first cycle of Radium-223 dichlorid
- Hemoglobin (Hb) ≥9,0 g/dl (100 g/l) without transfusion or erythropoietin within 4 weeks before the first administration of Radium-223 dichloride.
Exclusion criteria 4
- Presence of visceral disease and/or other disease conditions for which treatment with cytotoxic chemotherapy is clinically indicated.
- Presence of carcinomatous lymphangitis
- atients with a history of other cancers, except treated basal cell carcinoma or superficial bladder cancer (Ta and Tis, American Joint Committee on Cancer, 7th edition)
- Previous systemic radiation therapy with strontium-89, samarium-153, rhenium-186, or rhenium-188.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 3
- PFS (progression-free survival, understood as the time between signing the informed consent to the study and documented disease progression or death from any cause)
- Reduction of pain from bone metastases
- QOL (quality of life)
Secondary endpoints 4
- OS (Overall Survival, understood as the time between signing the informed consent to the study and death from any cause)
- Survival free from symptomatic skeletal events
- Time to total alkaline phosphatase (ALP) progression (calculated from baseline to the first quantitative increment)
- Reduction in ALP value (calculated from baseline to the maximum reduction recorded during treatment/follow-up)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 1
—
SCP31339869 · ATC
- Route of administration
- INTRAVENOUS INJECTION
- Max daily dose
- 55 KBq/Kg kilobecquerel(s)/kilogram
- Max total dose
- 330 KBq/Kg kilobecquerel(s)/kilogram
- Max treatment duration
- 18 Month(s)
- Authorisation status
- Authorised
- ATC code
- V10XX03 — RADIUM (223RA) DICHLORIDE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Comparator 3
SCP136961 · ATC
- Active substance
- Anastrozole
- Route of administration
- ORAL USE
- Max daily dose
- 1 mg milligram(s)
- Max total dose
- 548 mg milligram(s)
- Max treatment duration
- 84 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02BG03 — ANASTROZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP1154118 · ATC
- Active substance
- Letrozole
- Route of administration
- ORAL USE
- Max daily dose
- 2.5 mg milligram(s)
- Max total dose
- 4563 mg milligram(s)
- Max treatment duration
- 240 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02BG04 — LETROZOLE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SCP136386 · ATC
- Active substance
- Exemestane
- Route of administration
- ORAL USE
- Max daily dose
- 25 mg milligram(s)
- Max total dose
- 13700.00 mg milligram(s)
- Max treatment duration
- 84 Week(s)
- Authorisation status
- Authorised
- ATC code
- L02BG06 — EXEMESTANE
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Sponsor organisation
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Address
- Via Del Vespro 129
- City
- Palermo
- Postcode
- 90127
- Country
- Italy
Scientific contact point
- Organisation
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Contact name
- renato patrizio costa
Public contact point
- Organisation
- Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
- Contact name
- renato patrizio costa
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Authorised, recruitment pending | 50 | 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 13 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol_EU CT 2025-524208-31-00 | 4 |
| Protocol (for publication) | FRONT PAGE PROTOCOL EU CT 2025-524208-31-00 | 3 |
| Protocol (for publication) | Protocol Appendices_EN | 2 |
| Protocol (for publication) | PROTOCOL TC VERSION | 4 |
| Recruitment arrangements (for publication) | K1_RECRUITMENT ARRANGEMENT_EN | 1 |
| Subject information and informed consent form (for publication) | L1_ICF adults_IT | 1 |
| Subject information and informed consent form (for publication) | L1_SIS adults_IT | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPc_Xofgo_EN | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | IB_ANASTROZOLO_IT | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | IB_EXEMESTANE_IT | 2 |
| Summary of Product Characteristics (SmPC) (for publication) | IB_LETROZOLE_IT | 2 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis IT_EU CT 2025-524208-31-00 def | 4 |
| Synopsis of the protocol (for publication) | D1_Protocol Synopsis_EN_EU CT 2025-524208-31-00 | 4 |
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2026-02-16 | Italy | Acceptable 2026-05-18
|
2026-06-08 |