Impact of Endocrine Therapy, Menstrual Cycle, PAM50, Ki67 on Treatment Decisions in HR+ and HER2- Breast Cancer
Recruiting
Observational Study
Hormone Receptor Positive HER-2 Negative Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Age
- 18 and older
- Sex
- Female
- Study type
- Observational
- Participants needed
- 504 (estimated)
- Sponsor
- University Hospital Tuebingen · Other
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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…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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…
Contacts