Clinical trial • Phase I • Oncology

AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer

Phase I trial of AZD9833 for Estrogen receptor-positive HER2-negative advanced breast cancer. 347 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Estrogen receptor-positive HER2-negative advanced breast cancer
Trial Stage
Phase I

Key dates

Initial CTIS Submission Date
24-04-2024
First CTIS Authorization Date
29-04-2024

Trial design

Phase I trial across 5 sites in Spain.

Target Sample Size
347

Recruitment

Planned Sample Size
347
Recruitment Window Months
99

Geography

Total Number Of Sites
5
Total Number Of Participants
347

Spain

Earliest CTIS Part Ii Submission Date
13-12-2023
Latest Decision Or Authorization Date
12-03-2026
Processing Time Days
820
Number Of Sites
5
Number Of Participants
173

Sites

Site Name
Hospital Clinic De Barcelona
Department Name
Medical Oncology
Contact Person Name
Ivan Victoria Ruiz
Contact Person Email
ivictori@recerca.clinic.cat
Site Name
Hospital Universitario Hm Sanchinarro
Department Name
Medical Oncology
Contact Person Name
Irene Moreno
Contact Person Email
irene.moreno@startmadrid.com
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Medical Oncology
Contact Person Name
Manuel Ruiz Borrego
Contact Person Email
ruizsabater@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Medical Oncology
Contact Person Name
Mafalda Oliveira
Contact Person Email
moliveira@vhio.net
Site Name
Hospital Clinico Universitario De Valencia
Department Name
Medical Oncology
Contact Person Name
Begona Bermejo de las Heras
Contact Person Email
begobermejo@gmail.com

Sponsor

Primary sponsor

Full Name
Astrazeneca AB
Organisation Type
Pharmaceutical company
Country Of Registered Address
Sweden

Investigational products

Investigational Product Name
AZD9833
Combination Treatment
Yes

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