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

Hormone Receptor Positive HER-2 Negative Breast Cancer Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Background of the study Chemotherapy and anti-hormonal therapies improve the chances of cure for patients with early-stage hormone receptor (HR)-positive/HER2-negative breast cancer. However, only a few patients benefit from chemotherapy, as classical tumor characteristics such as grading, tumor size, and lymph node involvement in the armpit have a prognostic value but do not allow predictions about the effectiveness of chemotherapy. New treatment concepts, such as gene expression tests and preoperative endocrine therapy, aim to identify patients with a high risk of recurrence and provide them with optimized treatment. Additionally, initial study results indicate that a woman's menstrual cycle could influence the tumor's growth rate. These hints need to be investigated in larger studies to understand how the growth rate of a tumor in different phases of the menstrual cycle can be interpreted. Purpose of the study The main objective of the PEAK study is to investigate to what extent the menstrual cycle phase influences the tumor growth rate (biomarker Ki67). To make a scientifically sound statement, the growth rate of the tumor in postmenopausal patients must also be examined. In addition, the impact of preoperative anti-hormonal therapy, the dynamics of the growth marker Ki67, and the individual genetic risk (PAM50 gene test) on recommendations for adjuvant therapy in clinical routine should be evaluated. Furthermore, the influence of the aforementioned markers on established clinical-pathological risk factors and the spread of tumor cells should be assessed. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Hormone Receptor Positive HER-2 Negative Breast Cancer

• NCT number: NCT05878314
• Study type: Observational
• Source: University Hospital Tuebingen
• Contact: Dominik Dannehl, Dr.
• Phone: 07071 29 82211
• Email: Dominik.Dannehl@med.uni-tuebingen.de
• Status: Recruiting
• Start date: April 25, 2023
• Completion date: April 2035