Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - First administration to humans
Status
Ongoing, recruitment ended
Participants planned
520
Countries
1
Sites
5
"Estrogen Receptor Positive HER2 Negative Advanced Breast Cancer"
Key facts
- Sponsor
- Astrazeneca AB
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 1 Mar 2019 → ongoing
- Decision date (initial)
- 2024-04-29
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506890-37-00
- EudraCT number
- 2018-000667-92
- ClinicalTrials.gov
- NCT03616587
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
"Estrogen Receptor Positive HER2 Negative Advanced Breast Cancer"
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Astrazeneca AB
- Sponsor organisation
- Astrazeneca AB
- Address
- Astraallen Gartuna, Karlebyhus Byggnad 674 Karlebyhus Byggnad 674
- City
- Sodertalje
- Postcode
- 151 85
- Country
- Sweden
Scientific contact point
- Organisation
- Astrazeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Public contact point
- Organisation
- Astrazeneca AB
- Contact name
- AstraZeneca Clinical Study Information Center
Locations
1 EU/EEA country · 5 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 173 | 5 |
| Rest of world
United States, United Kingdom
|
— | 347 | — |
Investigational sites
Hospital Universitario Hm Sanchinarro
Medical Oncology, Calle Ona 10, 28050, Madrid
Hospital Clinic De Barcelona
Medical Oncology, Calle Villarroel 170, 08036, Barcelona
Hospital Universitari Vall D Hebron
Medical Oncology, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
University Hospital Virgen Del Rocio S.L.
Medical Oncology, Avenida De Manuel Siurot S/n, 41013, Sevilla
Hospital Clinico Universitario De Valencia
Medical Oncology, Avenida Blasco Ibanez 17, 46010, Valencia
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 |
|---|---|---|---|---|---|
| Spain | 2019-03-01 | 2019-03-18 | 2024-01-11 |
Application history
7 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-04-24 | Spain | Acceptable 2024-04-29
|
2024-04-29 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-19 | Spain | Acceptable 2024-08-14
|
2024-08-14 |
| 3 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2025-01-31 | Spain | Acceptable 2024-08-14
|
2025-01-31 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-31 | Spain | Acceptable 2025-03-17
|
2025-03-18 |
| 5 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-07-10 | Spain | Acceptable 2025-09-11
|
2025-09-15 |
| 6 | SUBSTANTIAL MODIFICATION | SM-5 | 2026-01-19 | Spain | Acceptable 2026-03-09
|
2026-03-11 |
| 7 | NON SUBSTANTIAL MODIFICATION | NSM-2 | 2026-03-12 | Spain | Acceptable 2026-03-09
|
2026-03-12 |