Treatment: All Patients for Relapse

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Huntsman Cancer Institute at University of Utah, Salt Lake City, UT
Relapse+2 More
Functional Precision Oncology - Other
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a prospective phase 2 study to use Functional Precision Oncology (FPO) to predict, prevent and treat early metastatic recurrence in subjects with HR-low/Her2 negative or triple negative breast cancer.

Eligible Conditions

  • Relapse
  • Recurrent Breast Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 7 Secondary · Reporting Duration: up to 3 years

Data will be assessed at 3-years from the time of definitive surgery.
Compare the recurrence rates between patients whose tumors successfully engrafted in mice (PDX+) vs. not (PDX-)
up to 3 years
Calculate PFS ratios of 2nd line FPO-informed: 1st line "uninformed" therapy as a preliminary measure of efficacy
Correlation between MHCII Immune Activation Score (high vs. low and as a continuous variable) and tumor engraftment (PDX+/-) and clinical outcomes (relapse-free and overall survival).
Correlation between methylated ctDNA measurements as assessed using the MethylPatch assay pretreatment, pre- and post surgery, with PDX engraftment data (+/-) and clinical outcomes (relapse-free and overall survival)
Correlation between tumor engraftment (PDX+/-) and relapse-free survival, overall survival, and response to preoperative chemotherapy and treatment response as assessed on the Residual Cancer Burden scale
Proportion of cases where any type of patient derived models are successfully generated and clinically actionable therapies are identified by functional precision oncology.
Proportion of cases where clinically actionable therapies were identified by FPO.
determine the feasibility of returning FPO results to inform the selection of 2nd line therapy after recurrence
frequency with which therapeutic responses in PDX, PDxO, and/or PDO align with the clinical, radiographic, and pathologic responses observed in the matched patient

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

2 Treatment Groups

Physician Questionnaire
1 of 2
Treatment: All Patients
1 of 2
Active Control
Experimental Treatment

80 Total Participants · 2 Treatment Groups

Primary Treatment: Treatment: All Patients · No Placebo Group · Phase 2

Treatment: All Patients
Other
Experimental Group · 1 Intervention: Functional Precision Oncology · Intervention Types: Other
Physician QuestionnaireNoIntervention Group · 1 Intervention: Physician Questionnaire · Intervention Types:

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 years
Closest Location: Huntsman Cancer Institute at University of Utah · Salt Lake City, UT
Photo of Salt Lake City  1Photo of Salt Lake City  2Photo of Salt Lake City  3
2011First Recorded Clinical Trial
0 TrialsResearching Relapse
68 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have invasive breast cancer that is triple negative or hormone receptor-low/Her2 negative.
You have HER2 expression 0 or 1+ on IHC or non-amplified (defined as HER2/CEP17 ratio <2 or copy number <6) on fluorescence in situ hybridization (FISH).
Patients with primary breast cancer, local lymph node metastasis that is ≥ 1.5 cm, and inflammatory breast cancer are eligible
You are considered for preoperative cytotoxic chemotherapy.
You are willing and capable to undergo baseline tumor material collection from the primary tumor or lymph node metastasis.
A participant is eligible if he or she is 18 years of age or older.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.