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Precision Medicine
Precision Oncology for Metastatic Breast Cancer (FORESEE Trial)
N/A
Recruiting
Led By Saundra Buys, 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
ECOG Performance Status ≤ 2
Metastatic or recurrent unresectable breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
FORESEE Trial Summary
This trial will assess the feasibility of providing comprehensive genomic information and testing for drug sensitivity to patients with metastatic breast cancer. It will also explore how this information influences physicians' selection of next-line therapy.
Who is the study for?
This trial is for adults with metastatic breast cancer who haven't had treatment in the metastatic setting, can safely have a tumor sample taken, and are expected to live at least 6 more months. It's not for those with serious heart or liver problems, other cancers likely to affect survival within 5 years, or if they can't undergo safe tumor collection.Check my eligibility
What is being tested?
The study tests personalized genomic profiling and drug sensitivity analysis to guide doctors in choosing treatments after standard care fails. Patients will get tailored information based on their cancer's specific genetic makeup before progressing on current therapies.See study design
What are the potential side effects?
Since this trial focuses on precision medicine rather than a specific new drug, side effects will vary depending on the individualized therapy chosen based on genomic testing results.
FORESEE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can take care of myself but might not be able to do heavy physical work.
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My breast cancer has spread and cannot be removed by surgery.
Select...
I have at least one cancer lesion that can be monitored with scans or physical exams.
Select...
My breast cancer is not HER2 positive.
Select...
I can safely have a biopsy.
Select...
I am post-menopausal or not pregnant if pre-menopausal.
Select...
I have triple-negative breast cancer and haven't been treated for it in its advanced stage.
FORESEE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of cases where clinically actionable outcomes were identified by the use of organoids and drug screening (functional precision oncology).
Secondary outcome measures
Concordance: To assess the frequency with which our functional precision oncology testing identifies the same therapeutic vulnerabilities identified by commercial (gold standard) testing.
Performance: comparison between the number of clinically actionable outcomes identified by our functional genomic characterization and commercially available assays
The time from patient sample collection to return of drug screening results.
+1 moreFORESEE Trial Design
2Treatment groups
Experimental Treatment
Group I: Treatment: all patientsExperimental Treatment1 Intervention
Blood will be collected, and a biopsy will be performed prior to starting the first systemic therapy (triple-negative) or first chemotherapy (hormone receptor-positive). If enough tumor is collected, the patient is eligible for the trial. Malignant tissue collected from this biopsy will be used for genomic sequencing and for the development of organoid models for drug screening. Drugs selected for sensitivity testing will be guided by the results of the genome analysis and NCCN guidelines. Following tissue acquisition, the patient will begin therapy as selected by the treating physician. This first-line of on study therapy, either standard-of-care or investigational in the context of another existing active clinical trial, will be defined as the first "uninformed" line of therapy.
Patient response is tracked for up to two uninformed lines of therapy. The first line of the therapy started after the biopsy will count as the first uniformed line.
Group II: Physician QuestionnaireExperimental Treatment1 Intervention
The results from the drug screening and mutation testing will be summarized and returned to the treating physician before the assignment of on study, second-line therapy. Before and after returning results, the treating physician will be administered a survey to assess the potential effect that the precision medicine results have on the selection of the following line of therapy. If a patient begins a therapy that was recommended by the precision medicine results, the therapy will be defined as the "informed" line of therapy.
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Who is running the clinical trial?
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,674 Total Patients Enrolled
15 Trials studying Breast Cancer
7,124 Patients Enrolled for Breast Cancer
Saundra Buys, MDPrincipal InvestigatorHuntsman Cancer Institute
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can take care of myself but might not be able to do heavy physical work.I do not have any severe heart, kidney, or liver conditions that would prevent me from receiving standard chemotherapy.I have brain metastases or cranial epidural disease.My breast cancer has spread and cannot be removed by surgery.My breast cancer is hormone receptor-positive, and I've tried or refused all hormone treatments without having chemotherapy for its advanced stage.My only tumor sample for testing can be taken from liver metastases.I have at least one cancer lesion that can be monitored with scans or physical exams.I cannot or do not want to undergo chemotherapy.My breast cancer is not HER2 positive.I am 18 years old or older.I can safely have a biopsy.I am post-menopausal or not pregnant if pre-menopausal.I have triple-negative breast cancer and haven't been treated for it in its advanced stage.Collecting a tumor sample from me is too risky due to my health condition.I have been diagnosed with another cancer with a life expectancy of less than 5 years.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment: all patients
- Group 2: Physician Questionnaire
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this research endeavor currently accessible to participants?
"According to clinicaltrials.gov, this medical trial is still recruiting qualified participants; it was inaugurated on 16th February 2021 and the latest modifications were made on 9th June 2022."
Answered by AI
How many participants are involved in the experiment?
"Affirmative. The information available on clinicaltrials.gov shows that this medical research project is presently looking for participants. It was initially posted in February 2021 and underwent a subsequent edit in June 2022, with the goal of enrolling 15 patients from one site."
Answered by AI
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