Overview
Sponsor-declared trial summary
Phase
Human pharmacology (Phase I) - Other
Status
Ongoing, recruitment ended
Participants planned
158
Countries
1
Sites
7
Locally Advanced or Metastatic Estrogen Receptor−Positive Breast Cancer
Key facts
- Sponsor
- Genentech Inc.
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Female
- Therapeutic area
- Diseases [C] - Neoplasms [C04]
- Trial duration
- 18 Jun 2018 → ongoing
- Decision date (initial)
- 2024-02-23
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
External identifiers
- EU CT number
- 2023-506700-12-00
- EudraCT number
- 2017-002083-41
Trial design
CTIS Part I — objectives, methods, condition coding
Conditions and MedDRA coding
Locally Advanced or Metastatic Estrogen Receptor−Positive Breast Cancer
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Genentech Inc.
- Sponsor organisation
- Genentech Inc.
- Address
- 1 Dna Way
- City
- South San Francisco
- Postcode
- 94080-4918
- Country
- United States
Scientific contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Public contact point
- Organisation
- Genentech Inc.
- Contact name
- US Program Manager Product Development Regulatory
Locations
1 EU/EEA country · 7 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Ongoing, recruitment ended | 45 | 7 |
| Rest of world
Korea, Republic of, United Kingdom, Australia, United States
|
— | 113 | — |
Investigational sites
MD Anderson Cancer Center
Oncologia, Calle De Arturo Soria Nº 270, 28033, Madrid
Hospital Universitario Hm Sanchinarro
Oncologia Medica, Calle Ona 10, 28050, Madrid
Hospital Universitari Vall D Hebron
Oncologia Medica, Edificio Materno-Infantil, Passeig De La Vall D'hebron 119-129, Barcelona
Institut Catala D'oncologia
Oncologia Medica, Avinguda De La Gran Via De L'hospitalet 199-203, 08908, L'hospitalet De Llobregat
Hospital Clinico Universitario De Valencia
Oncologia Medica, Avenida Blasco Ibanez 17, 46010, Valencia
Hospital General Universitario Gregorio Maranon
Oncologia Medica, Calle Del Doctor Esquerdo 46, 28007, Madrid
Hospital Universitario Ramon Y Cajal
Oncologia Medica, Carretera Del Colmenar Viejo Km 9 100, Por El Pardo, Madrid
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 | 2018-06-18 | 2018-07-06 | 2021-01-14 |
Application history
5 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-02-21 | Spain | Acceptable 2024-02-23
|
2024-02-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-06-15 | Spain | Acceptable 2024-07-30
|
2024-07-30 |
| 3 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-01-31 | Spain | Acceptable 2025-04-07
|
2025-04-07 |
| 4 | SUBSTANTIAL MODIFICATION | SM-4 | 2025-06-27 | Spain | Acceptable 2025-09-03
|
2025-09-05 |
| 5 | NON SUBSTANTIAL MODIFICATION | NSM-1 | 2026-04-21 | Spain | Acceptable 2025-09-03
|
2026-04-21 |