Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05878314
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2023-05-04
Brief Title:
Impact of Endocrine Therapy Menstrual Cycle PAM50 Ki67 on Treatment Decisions in HR and HER2- Breast Cancer
Sponsor:
University Hospital Tuebingen
Organization:
University Hospital Tuebingen
Study Overview
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
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Background of the study Chemotherapy and anti-hormonal therapies improve the chances of cure for patients with early-stage hormone receptor HR-positiveHER2-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 womans menstrual cycle could influence the tumors 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None