A proof of concept study to evaluate treatment efficacy by monitoring minimal residual disease using ctDNA in a HR-positive/HER2-negative early breast cancer population

Medica Scientia Innovation Research, S.L. (MEDSIR)0 sites1,260 target enrollmentSeptember 22, 2023

ConditionsEarly breast cancer Cancer

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Early breast cancer
Sponsor: Medica Scientia Innovation Research, S.L. (MEDSIR)
Enrollment: 1260
Status: Active, Not Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

September 22, 2023

End Date

June 30, 2028

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

Medica Scientia Innovation Research, S.L. (MEDSIR)

Eligibility Criteria

Inclusion Criteria

•Surveillance phase:
•1\. Signed ICF prior to participation in any study\-related activities
•2\. Male or female patients aged 18 years or older
•3\. ECOG 0 or 1
•4\. Histologically proven primary HR\-positive according to the updated ASCO/CAP 2020 guidelines and HER2\-negative BC as per ASCO/CAP 2018 criteria based on local testing on the most recent analyzed biopsy
•5\. Patients with high\-risk early\-stage BC according to at least one of the following criteria:
•5\.1\. If no previous neoadjuvant chemotherapy:
•5\.1\.1\. pN2/N3 or
•5\.1\.2\. pN1,1\. pT3/T4 and/or
•5\.2\. High genomic risk defined as Oncotype Dx Recurrence Score \> 25 if postmenopausal;\> 20 if pre\-menopausal, Prosigna score \= 41, Mammaprint high risk category or similar and/or

Exclusion Criteria

•Surveillance phase:
•1\. Any concurrent or planned treatment for the current diagnosis of BC other than adjuvant ET
•2\. Diagnosis of an alternative cancer in the five years prior to primary BC diagnosis other than for nonmelanoma carcinoma of the skin or cervical carcinoma in situ. Other stage I tumors will be discussed case by case prior to inclusion with the Medical Monitor of the study
•3\. Active or prior documented inflammatory bowel disease (i.e. Crohn's disease, ulcerative colitis, or a preexisting chronic condition resulting in baseline grade \=1 diarrhea) that may significantly alter the absorption of oral drugs
•4\. Active cardiac disease or history of cardiac dysfunction including any of the following:
•4\.1\. History (within 2 years from screening) or presence of idiopathic bradycardia or resting heart rate \<50 beats per minute at screening
•4\.2\. History of angina pectoris or symptomatic coronary heart disease within 12 months prior to study entry
•4\.3\. QT interval corrected through use of Fridericia’s formula (QTcF) \>450 ms for women and \>470 ms for men by at least three electrocardiograms (ECGs) \> 30 minutes apart
•4\.4\. History or presence of an abnormal ECG that is clinically significant in the investigator’s opinion
•4\.5\. History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias such as structural heart disease (e.g., severe left ventricular systolic dysfunction, left ventricular hypertrophy cardiomyopathy, infiltrative cardiomyopathy, moderate\-to\-severe valve disease), coronary heart disease (symptomatic or with ischemia demonstrated by diagnostic testing), clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of long QT syndrome within 12 months