Blood Biomarkers for Breast Cancer Treatment Response

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Pittsburgh

About this trial

This study looks at whether a simple blood test can help predict how well a breast cancer treatment will work. It follows patients with advanced hormone receptor-positive breast cancer whose cancer has progressed after their first treatment.

Researchers collect a blood sample when patients start a second hormone therapy treatment and may collect additional samples over time. By comparing blood test results with patient outcomes, the study aims to identify biomarkers that can predict which patients are most likely to benefit from treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must be ≥18 years of age

Clinical stage IV

HR positive

Progressing on first line treatment

Disqualifiers

None

Trial population

All patients with metastatic breast cancer refer to UPMC all sites

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 1 trial group
Group A: breast cancer stage IV patients

Trial outcomes

Primary outcomes

1

To Assess the performance of the baseline PERDI score

Assessment of the performance of the baseline PERDI score, derived from plasma patients collected prior to the start of their second-line endocrine therapy (2L ET) using an epigenomics-based cell-free DNA (cfDNA) profiling assay, in predicting Progression-free survival (PFS).

Time frame
From the time between date of first day of 2L ET treatment and date of progression or death, whichever occurs first at 6 months or 1 year

Secondary outcomes

1

Assessment of the baseline modified PERDI score

Preform a prospective cross-study meta-analysis of both PERDI and modifies PERDI. Progression-free survival (PFS) will be compared between modified PERDI-positive and negative derived from plasma collected at the start of second line therapy using epigenomics- based cfDNA profiling assay.

Time frame
6 months or 1 year after start 2L therapy

Other outcomes

Sponsors and contacts

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University of Pittsburgh

Lead sponsor

Precede Biosciences

Collaborator

This trial is not recruiting at the moment. You can still explore other options: