Genetic Testing for Breast Cancer Response Prediction

Recruiting in Palo Alto (17 mi)

Overseen bySenthilkumar Damodaran

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: M.D. Anderson Cancer Center

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?This phase II trial studies how well genetic testing works in predicting tumor response in patients with stage I-III HER2 negative invasive breast cancer. Genetic testing is a procedure that tests tumor samples to learn if certain genes are activated (turned on) in the tumor and if the activation of these genes may predict if the tumor will be sensitive or resistant to routine breast cancer treatments, such as chemotherapy or hormonal therapy.

Eligibility Criteria

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.

Inclusion Criteria

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.

The main tumor is at least 1 cm in size based on clinical or radiologic measurements.

Exclusion Criteria

You had surgery to remove the main breast cancer before.

You have breast cancer with a specific genetic change called HER2-positive.

You have already received medication or radiation treatment for breast cancer.

+3 more

Participant Groups

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.

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.