Clinical trial • Phase I/II • Oncology

Clinical trial in Triple negative breast cancer

Phase I/II trial for Triple negative breast cancer. Placebo control group (details not specified). 50 participants.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
Triple negative breast cancer
Trial Stage
Phase I/II
Drug Modality
Cell therapy

Key dates

Initial CTIS Submission Date
27-04-2024
First CTIS Authorization Date
29-07-2024

Trial design

Placebo control group (details not specified) Phase I/II trial across 1 site in Slovenia.

Comparator
Placebo control group (details not specified)
Target Sample Size
50

Recruitment

Planned Sample Size
50
Recruitment Window Months
47

Geography

Total Number Of Sites
1
Total Number Of Participants
50

Slovenia

Earliest CTIS Part Ii Submission Date
02-07-2024
Latest Decision Or Authorization Date
29-07-2024
Processing Time Days
27
Number Of Sites
1
Number Of Participants
50

Sites

Site Name
Institute Of Oncology Ljubljana
Department Name
Sektor internistične onkologije
Contact Person Name
Simona Borštnar
Contact Person Email
SBorstnar@onko-i.si
Number Of Participants
50

Sponsor

Primary sponsor

Full Name
Celica d.o.o.
Organisation Type
Laboratory/Research/Testing facility
Country Of Registered Address
Slovenia

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