Impact of Endocrine Therapy, Menstrual Cycle, PAM50, Ki67 on Treatment Decisions in HR+ and HER2- Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorUniversity Hospital Tuebingen
About this trial
PEAK is a prospective, multicenter, non-interventional investigator-initiated trial (IIT) that aims to investigate the influence of the menstrual cycle phase on Ki67 in patients who either receive Tamoxifen, Aromatase inhibitors ± gonadotropin-releasing hormone (GnRH)-Analogues or nothing or no preoperative endocrine treatment as part of the clinical routine. The investigators moreover address the question whether PAM50 assessment in addition to Ki67 dynamics still impacts treatment recommendations.
Eligibility criteria
Qualifiers
women ≥ 18 years of age
histologically proven unilateral primary non-metastatic invasive breast cancer
Estrogen receptor (ER)-/ or Progesterone receptor (PR)- positive and HER2-negative
Ki67 from core biopsy is available
Disqualifiers
ER-negative and PR-negative
HER2-positive
bilateral breast cancer
preexisting cancer disease within the last 10 years
Trial design
Treatments tested in this trial
- Not listed
Trial groups
504 Participants
are grouped into 3 trial groupsSponsors and collaborators
University Hospital Tuebingen
Lead sponsor
University Hospital Ulm
Collaborator
University Hospital Freiburg
Collaborator
Source ClinicalTrials.gov