RecruitingNCT05878314

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


Sponsor

University Hospital Tuebingen

Enrollment

504 participants

Start Date

Apr 25, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates how hormonal status (including menstrual cycle phase) and a short course of hormone therapy before surgery affect certain biological markers — including a gene test called PAM50 and a protein called Ki67 — in women with early-stage hormone receptor-positive, HER2-negative breast cancer. The goal is to better understand how to personalize treatment decisions. **You may be eligible if...** - You are a woman aged 18 or older - You have been diagnosed with unilateral (one-sided), non-metastatic invasive breast cancer that is estrogen or progesterone receptor-positive and HER2-negative - Your underarm lymph nodes appear clear on examination and ultrasound - You are scheduled for surgery and a short course of pre-operative hormone therapy (Tamoxifen, aromatase inhibitor, or Goserelin) for 2–4 weeks - Your Ki67 result from a core biopsy is available **You may NOT be eligible if...** - You have HER2-positive cancer - You have bilateral breast cancer - You need or are recommended for neoadjuvant chemotherapy - You have had another cancer in the past 10 years - You are pregnant or breastfeeding - You have used hormonal contraception within 6 months before enrollment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Department of Women's Health

Tübingen, Germany

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NCT05878314


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