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Genetic Testing for Breast Cancer Response Prediction

Phase 2
Waitlist Available
Led By Senthilkumar Damodaran
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
The patient can undergo biopsy or surgery of a primary tumor site for suspected or proven invasive breast cancer of clinical stage I to III; stage IV patients will be allowed and included in the feasibility assessment, but will not be included in outcomes analysis for secondary objectives
The clinical or radiologic primary tumor size is at least 1 cm diameter
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time between diagnostic tumor biopsy and the first failure event, assessed at 3 and 5 years
Awards & highlights

Study Summary

This trial looks at how well genetic testing can predict how well patients with stage I-III HER2 negative breast cancer will respond to treatment.

Who is the study for?
This trial is for individuals with stage I-III HER2 negative invasive breast cancer, who have a tumor at least 1 cm in diameter and can undergo biopsy or surgery. It's not for those who had prior breast cancer treatments, other cancers within the last 5 years (except certain skin cancers), or tumors obscured by hematoma/biopsy changes.Check my eligibility
What is being tested?
The study is testing if genetic testing on tumor samples can predict how well these tumors will respond to standard breast cancer treatments like chemotherapy or hormonal therapy. This could help tailor treatment plans to individual patients.See study design
What are the potential side effects?
While the trial itself focuses on genetic testing which doesn't cause side effects, subsequent standard treatments based on test results may include typical side effects of chemotherapy or hormonal therapy such as nausea, fatigue, hair loss, and increased risk of infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You can have a biopsy or surgery for suspected or confirmed invasive breast cancer in its early to advanced stages. If you have stage IV cancer, you can take part in the study to see if the treatment works, but your results won't be included in some of the analysis.
Select...
The main tumor is at least 1 cm in size based on clinical or radiologic measurements.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time between diagnostic tumor biopsy and the first failure event, assessed at 3 and 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and time between diagnostic tumor biopsy and the first failure event, assessed at 3 and 5 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
Feasibility defined as the ability to classify patients into 1 of 4 cohorts
Secondary outcome measures
Concordance of genomic analysis with immunohistochemistry (IHC)
Disease-free survival (DFS)
Frequency of tumors
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Diagnostic (biopsy, surgery, genetic testing)Experimental Treatment3 Interventions
Patients undergo biopsy or surgery to obtain tumor sample for genetic testing. Patients are then assigned to 4 treatment cohorts as determined by genetic test results.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biopsy
2014
Completed Phase 4
~1090
Conventional Surgery
2006
Completed Phase 3
~1080

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,958 Previous Clinical Trials
1,797,349 Total Patients Enrolled
148 Trials studying Breast Cancer
63,286 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,914,546 Total Patients Enrolled
939 Trials studying Breast Cancer
1,543,333 Patients Enrolled for Breast Cancer
Senthilkumar DamodaranPrincipal InvestigatorM.D. Anderson Cancer Center
5 Previous Clinical Trials
87 Total Patients Enrolled

Frequently Asked Questions

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

What health risks may arise from Genetic Testing?

"While there is some evidence affirming the safety of Genetic Testing, due to its Phase 2 classification, it has been rated a 2. At present, no data exists that confirms the efficacy of this treatment option."

Answered by AI

Are there currently any openings for enrollment in this trial?

"According to clinicaltrials.gov, this experimental research is not currently looking for recruits. It was uploaded on May 31st 2011 and amended most recently in September 2022; notwithstanding, there are 2287 other trials actively recruiting at present."

Answered by AI
~80 spots leftby Mar 2025