MESI-STRAT Endocrine Therapy Termination Trial

• Conditions: C50; Malignant neoplasm of breast

• Registration Number: DRKS00014942
• Lead Sponsor: Stiftung PATH Biobank

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-20
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Enrolling by invitation
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

sample donation for the PATH Biobank at timepoint of primary surgery, estrogen receptor positive breast cancer, antihormonal therapy reported in follow-up and within the last, fifth year of therapy

Exclusion Criteria

other therapy for BC (breast cancer) than ET ongoing, inflammatory cancers, pregnancy, any medical condition (e.g. substance abuse) that may, in the clinical judgement of the investigator, independently influence the subject’s outcome during this study, participation in another interventional clinical trial within the last four weeks

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of MESI (metabolic and signal network) marker panel alterations in serum and urine in the presence and absence of ET (Endocrine Therapy)

Secondary Outcome Measures

Name	Time	Method
Analysis of serum/urine from patients before and after termination of ET and comparison to clinical follow-up may allow identification of MESI marker alterations predictive of recurrence after termination of ET (Endocrine Therapy)