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Impact of Endocrine Therapy, Menstrual Cycle, PAM50, Ki67 on Treatment Decisions in HR+ and HER2- Breast Cancer

NCT05878314 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 504

Last updated 2026-02-10

No results posted yet for this study

Summary

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

  • Hormone Receptor Positive HER-2 Negative Breast Cancer

Sponsors & Collaborators

  • University Hospital Ulm

    collaborator OTHER

  • University Hospital Freiburg

    collaborator OTHER

  • University Hospital Tuebingen

    lead OTHER

Principal Investigators

  • Dominik Dannehl, Dr. · University Hospital Tuebingen

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-25
Primary Completion
2027-04-30
Completion
2035-04-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05878314 on ClinicalTrials.gov