Impact of Endocrine Therapy, Menstrual Cycle, PAM50, Ki67 on Treatment Decisions in HR+ and HER2- Breast Cancer
Launched by UNIVERSITY HOSPITAL TUEBINGEN · May 17, 2023
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
The PEAK trial is studying how the menstrual cycle may affect the levels of a marker called Ki67 in women with hormone receptor-positive, HER2-negative breast cancer. This trial is looking for women over 18 who have been diagnosed with this type of breast cancer and are planning to have surgery. Participants may receive treatments like Tamoxifen or Aromatase inhibitors for a short period before surgery, and the study will also explore whether assessing another marker called PAM50, alongside Ki67, can influence treatment decisions.
To be eligible for this trial, women must have a confirmed diagnosis of unilateral (one-sided) breast cancer that is not spread to the lymph nodes and is not suitable for chemotherapy. They should also not have any other significant health issues that would prevent them from participating. If you join the trial, you will be closely monitored, and your treatment plan may be adjusted based on the study's findings. This trial aims to improve how doctors make treatment decisions for women with this specific type of breast cancer.
Gender
FEMALE
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 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
- Exclusion Criteria:
- • 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
About University Hospital Tuebingen
University Hospital Tübingen is a leading academic medical institution in Germany, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. As a prominent sponsor of clinical trials, the hospital leverages its multidisciplinary expertise and cutting-edge facilities to develop new therapeutic strategies and improve patient outcomes. With a strong focus on translational medicine, University Hospital Tübingen collaborates with various stakeholders, including pharmaceutical companies and research organizations, to facilitate the efficient and ethical conduct of trials across a wide range of medical disciplines. Their dedication to patient-centered research and rigorous scientific standards positions them at the forefront of medical advancements.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Tuebingen, , Germany
Patients applied
Trial Officials
Dominik Dannehl, Dr.
Principal Investigator
University Hospital Tuebingen
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported