Public trial registry of the CCC-Munich

Trial ADAPTcycle

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

Trial
World
Trial acronym
:
ADAPTcycle
World
Full title
:

Adjuvant Dynamic marker - Adjusted Personalized Therapy comparing endocrine therapy plus ribociclib versus chemotherapy in intermediate risk, HR+/HER2- early breast cancer

World
Description
:

The WSG ADAPT trial program is one of the first new generation trials addressing the issue of individualization of (neo)-adjuvant decision-making in early breast cancer (EBC) in a subtype-specific manner. The first WSG ADAPT umbrella trial (NCT01779206) aimed to establish early predictive molecular surrogate markers for response after a short 3-week induction treatment.
The goals of the WSG ADAPT trial program - early response assessment and subtype-specific therapy tailoring to those patients who are most likely to benefit - have contributed to the very positive national and international feedback to the ADAPT concept as a whole.
The aim of this ADAPTcycle phase-III-trial is to investigate whether the intermediate-risk patient group identified during the screening phase derives additional benefit from treatment with ribociclib in combination with ET compared to chemotherapy (followed by adjuvant ET).

World
EudraCT number
:
World
NCT number
:
World
Responsible organization
:
Frauenklinik IN, Telefon: 089440054111
Indications
Classification Code Description
- Breastcancer
Trial design
World
Trial type
:
Interventional
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Blinding type
:
Open
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Phase
:
III
Status
World
Status
:
Recruitment active
Votes
World
Institutional review board - vote
:
Positive
Initiiation & lock
World
Date of lock (planned / actual)
:
2024-04-01 / Unknown
Therapy
World
Therapy line
:
1
Participants
Function Prename Surname Organization
World Principal Investigator NADIA HARBECK Keine Organisationseinheit angegeben Magnifier