Public trial registry of the CCC-Munich

Trial KEYRICHED 1

Trial Trial design Status In-/Exclusion Therapy Participants Documents Permissions Tumorboards

Trial
World
Trial acronym
:
KEYRICHED 1
World
Full title
:

Eine prospektive, multizentrische, offene, neoadjuvante einarmige Phase-II-Studie mit Pembrolizumab in Kombination mit dualer Anti-HER2-Blockade mit Trastuzumab und Pertuzumab bei Brustkrebspatientinnen im Frühstadium mit molekularem HER2-angereichertem intrinsischem Subtyp

World
Description
:

Trial treatment is defined as neoadjuvant therapy only. Investigational Medicinal Products (IMPs) are pembrolizumab (Keytruda®, Merck/MSD), trastuzumab biosimilar ABP 980 (Kanjinti®, Amgen) and pertuzumab (Perjeta®, Roche).
Pembrolizumab, trastuzumab biosimilar ABP 980 and pertuzumab will be labeled study-specifically. Documentation of preparation and distribution of pembrolizumab has to be recorded in accordance with the Investigator’s Brochure and of the trastuzumab biosimilar ABP 980 and pertuzumab according to the Summary of product characteristics (SmPC).

World
EudraCT number
:
World
NCT number
:
World
Responsible organization
:
Frauenklinik GH, Telefon: 089440076800
Indications
Classification Code Description
- Breastcancer
Trial design
World
Trial type
:
Interventional
World
Blinding type
:
Open
World
Phase
:
II
Status
World
Status
:
Recruitment finished
Votes
World
Institutional review board - vote
:
Unknown
Initiiation & lock
World
Date of lock (planned / actual)
:
2021-12-01 / Unknown
Therapy
World
Therapy line
:
1
Participants
Function Prename Surname Organization
World Principal Investigator NADIA HARBECK Keine Organisationseinheit angegeben Magnifier
World Responsible contact FRANZISKA HENZE Keine Organisationseinheit angegeben Magnifier