Actively Recruiting
Impact of Endocrine Therapy, Menstrual Cycle, PAM50, Ki67 on Treatment Decisions in HR+ and HER2- Breast Cancer
Led by University Hospital Tuebingen · Updated on 2026-02-10
504
Participants Needed
1
Research Sites
622 weeks
Total Duration
On this page
Sponsors
U
University Hospital Tuebingen
Lead Sponsor
U
University Hospital Ulm
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Impact of Endocrine Therapy, Menstrual Cycle, PAM50, Ki67 on Treatment Decisions in HR+ and HER2- Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- no lymph-node involvement by clinical evaluation and ultrasound (cN0)
- not amendable to neoadjuvant chemotherapy
- surgery or planned surgery at the Department for Women's Health, Tuebingen or Freiburg
- planned preoperative endocrine treatment with Tamoxifen, Aromatase inhibitors, Goserelin or nothing for 2 - 4 weeks
- written informed consent
You will not qualify if you...
- ER-negative and PR-negative
- HER2-positive
- bilateral breast cancer
- preexisting cancer disease within the last 10 years
- preexisting invasive ipsi- or contralateral breast cancer (non-invasive ipsi- or contralateral breast cancer is not regarded as an exclusion criteria)
- any systemic breast cancer therapy before inclusion into the trial
- indication for neoadjuvant chemotherapy
- any systemic therapy except Tamoxifen, Aromatase inhibitors, Goserelin before surgery
- locally advanced, inoperable or metastatic breast cancer
- pregnant or lactating patients
- inadequate general condition (not fit for chemotherapy)
- hormonal contraception within 6 months before inclusion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Women's Health
Tübingen, Germany, 72076
Actively Recruiting
Research Team
D
Dominik Dannehl, Dr.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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