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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

Be older than 18 years old

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ time between diagnostic tumor biopsy and the first failure event, assessed at 3 and 5 years

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

Conventional Surgery

2006

Completed Phase 3

~1080

Biopsy

2014

Completed Phase 4

~1090

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,986 Previous Clinical Trials

1,788,502 Total Patients Enrolled

148 Trials studying Breast Cancer

63,277 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,708 Previous Clinical Trials

40,931,629 Total Patients Enrolled

942 Trials studying Breast Cancer

1,543,966 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

Recent research and studies

clinicaltrials.govStudy

Genetic Testing in Predicting Tumor Response in Patients With Stage I-III HER2 Negative Invasive Breast Cancer

2011. "Genetic Testing in Predicting Tumor Response in Patients With Stage I-III HER2 Negative Invasive Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01334021.