Investigating how menstrual cycle phases affect treatment decisions in HR+ HER2- breast cancer
Impact of Preoperative Endocrine Therapy, Menstrual Cycle, PAM50 Assessment and Ki67 Dynamics on Adjuvant Treatment Decisions in Hormone Receptor-positive and HER2-negative Patients With Early Breast Cancer
University Hospital Tuebingen · NCT05878314
This study looks at how different phases of the menstrual cycle might affect treatment choices for women with hormone receptor-positive, HER2-negative breast cancer to help improve their care before surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 504 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital Tuebingen (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Tübingen) |
| Trial ID | NCT05878314 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older with unilateral, non-metastatic, invasive breast cancer that is estrogen and/or progesterone receptor-positive and HER2-negative.
Not a fit: Patients with ER-negative, PR-negative, or HER2-positive breast cancer, as well as those with bilateral breast cancer or prior systemic breast cancer therapy, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for women with HR+ HER2- breast cancer.
How similar studies have performed: While the influence of menstrual cycle phases on tumor growth is a relatively novel area of investigation, initial studies suggest potential insights that warrant further exploration.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tübingen
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Hormone Receptor Positive HER-2 Negative Breast Cancer