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Functional Precision Oncology for Breast Cancer Recurrence (TOWARDS-II Trial)

Phase 2
Recruiting
Led By Christos Vaklavas, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Histologically or cytologically confirmed invasive breast carcinoma that is triple negative (TNBC) or hormone receptor (HR)-low/Her2 negative
Primary tumor OR local lymph node metastasis that is ≥ 1.5 cm
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

TOWARDS-II Trial Summary

This trial will use a personalized approach to predicting, preventing and treating early metastatic recurrence in breast cancer patients.

Who is the study for?
This trial is for adults with invasive breast cancer that's triple negative or HR-low/Her2 negative, who haven't had prior therapy. They must be able to provide a biopsy sample and consent, have an ECOG Performance Status ≤ 2, and a life expectancy of ≥ 12 months. Excluded are those with Her2(+) cancer, other malignancies within the last 5 years, severe heart conditions, uncontrolled hypertension, or any condition affecting study compliance.Check my eligibility
What is being tested?
The trial tests Functional Precision Oncology (FPO) to predict and manage early metastatic recurrence in certain breast cancers. It involves collecting tumor samples before any treatment starts to develop personalized models like PDX or organoids for each patient.See study design
What are the potential side effects?
While specific side effects aren't listed for FPO as it's more of a testing strategy than a drug intervention, procedures involved such as biopsies may cause pain at the collection site, bleeding, infection risk and rare complications related to anesthesia.

TOWARDS-II Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is triple negative or has low hormone receptors and is HER2 negative.
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My cancer in the primary site or lymph nodes is larger than 1.5 cm.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 years old or older.
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My cancer is at an early to mid-stage (Stage I-III).
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I have not received any treatment for my breast cancer.
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I am post-menopausal or not pregnant.

TOWARDS-II Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Compare the recurrence rates between patients whose tumors successfully engrafted in mice (PDX+) vs. not (PDX-)
Proportion of cases where clinically actionable therapies were identified by FPO.
Secondary outcome measures
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)
+4 more

TOWARDS-II Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment: All PatientsExperimental Treatment1 Intervention
Patient derived xenografts (PDX) are grown in mice. Organoids may generated from patient tumor(PDO) and PDX(PDxO). Organoids will be used for drug profiling. PDX, organoid establishment and drug profiling will occur while patient is undergoing preoperative chemo, surgery, radiation, and may extend into disease-free interval. Patients receive first line therapy in the metastatic setting per SOC or in separate clinical trial. Results of PDM drug profiling, tumor genomic, and circulating tumor DNA results will be returned to treating physician to inform 2nd line therapy. At progression on the first line therapy, the patient will begin new therapy as directed by the treating physician. Any subsequent therapy (aligned or unaligned with report recommendations) that a patient starts after the return of results will be deemed "informed".
Group II: Physician QuestionnaireActive Control1 Intervention
Prior to the return of results, treating physicians will be asked to complete the PRE-Information Provider Survey on Functional Precision Oncology. After review of the FPO results, treating physicians will be asked to complete the POST-Information Provider Survey on Functional Precision Oncology to assess the potential effect that the FPO results have on the selection of therapy. These surveys will be administered to assess the impact the results have on the selection of therapy. Physicians are not mandated to select the treatment recommended by the FPO data since the FPO results are not from a CLIA certified laboratory. Information regarding whether the physician chose to switch to the recommended drug or not for the next line of therapy and patient outcomes (progression-free survival) according to treatment selection (treatment selected aligned with FPO recommendation vs. not) will be captured.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,092 Previous Clinical Trials
1,732,912 Total Patients Enrolled
15 Trials studying Breast Cancer
7,124 Patients Enrolled for Breast Cancer
United States Department of DefenseFED
859 Previous Clinical Trials
225,551 Total Patients Enrolled
37 Trials studying Breast Cancer
3,466 Patients Enrolled for Breast Cancer
Christos Vaklavas, MDPrincipal InvestigatorHuntsman Cancer Institute

Media Library

Functional Precision Oncology (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05464082 — Phase 2
Breast Cancer Research Study Groups: Physician Questionnaire, Treatment: All Patients
Breast Cancer Clinical Trial 2023: Functional Precision Oncology Highlights & Side Effects. Trial Name: NCT05464082 — Phase 2
Functional Precision Oncology (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05464082 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any volunteers currently needed for this research?

"The clinical trial in question appears to have closed enrollment, with the last update on the study being from October 20th, 2022. The trial was first posted December 31st, 2022. Although this particular research project is not looking for any more volunteers, there are 3,406 other trials currently enrolling participants."

Answered by AI

What are the benefits that researchers hope to gain from this clinical trial?

"The goal of this trial is to compare the recurrence rates of patients whose tumors successfully engrafted in mice (PDX+) with those who did not (PDX-). Secondary outcomes include correlations between tumor engraftment and relapse-free survival, overall survival, response to preoperative chemotherapy and treatment response as assessed on the Residual Cancer Burden scale; correlation between MHCII Immune Activation Score (high vs. low and as a continuous variable) and tumor engraftment; proportion of cases where any type of patient derived models are successfully generated and clinically actionable therapies are identified by functional precision oncology"

Answered by AI

What are the risks associated with Functional Precision Oncology treatments?

"There is some evidence backing the safety of this cancer treatment, but none to suggest that it is effective. Therefore, our team has given it a rating of 2."

Answered by AI
~45 spots leftby Sep 2025