Investigating how menstrual cycle phases affect treatment decisions in HR+ HER2- breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The PEAK study is a multicenter, non-interventional trial that examines the impact of menstrual cycle phases on tumor growth rates, specifically the biomarker Ki67, in women with hormone receptor-positive, HER2-negative breast cancer. It aims to evaluate how preoperative endocrine therapy and genetic risk assessments (PAM50) influence treatment recommendations. By analyzing these factors, the study seeks to optimize treatment strategies for patients undergoing surgery. The findings could provide insights into the timing and effectiveness of therapies based on individual patient characteristics.

Why it matters

Who can join: the full rules

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

Where it's running

• Department of Women's Health
  Tübingen, Germany Recruiting

Study contacts

• Principal investigator: Dominik Dannehl, Dr. — University Hospital Tuebingen
• Study coordinator: Dominik Dannehl, Dr.
• Email: Dominik.Dannehl@med.uni-tuebingen.de
• Phone: 07071 29 82211

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.