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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

No Placebo-Only Group

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility defined as the ability to classify patients into 1 of 4 cohorts

Secondary study objectives

Concordance of genomic analysis with immunohistochemistry (IHC)

Disease-free survival (DFS)

Frequency of tumors

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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