Patients with breast cancer, who have completed first line therapy (e.g., radiotherapy,
chemotherapy, surgery), and who have to be identified with having a high risk of recurrence
of cancer, will be eligible for the study. This patient group is currently offered a standard
of care chemotherapy plus endocrine therapy (ET). The study investigates whether the patient
group with high-risk early breast cancer benefits from treatment with the medication
abemaciclib in combination with ET compared to ET alone.
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
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
positive national and international feedback regarding the ADAPT-concept as a whole.
The aim of this ADAPTlate phase-III-trial is to gain further knowledge of the group of
patients at high risk for disease recurrence, who have completed definite locoregional
therapy (with or without neoadjuvant or adjuvant chemotherapy). This patient group is
currently offered an adjuvant chemotherapy plus endocrine therapy. Yet, the high-risk
population only receives suboptimum benefit from standard ET and often develops resistance
against ET at time of recurrence. With ADAPTlate it is planned to investigate if the
high-risk patient group identified during the screening phase derives additional benefit from
treatment with abemaciclib in combination with ET compared to ET alone.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.