Pre-Surgery Radiation Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen bySimona F. Shaitelman

Age: 18+

Sex: Any

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 6 Jurisdictions

Trial Summary

What is the purpose of this trial?This phase II trial studies how well radiation therapy before surgery works in treating patients with hormone receptor positive, HER2 negative breast cancer. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Giving radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

Eligibility Criteria

This trial is for adults with hormone receptor positive, HER2 negative breast cancer who are fit enough for treatment (ECOG 0-1). They must have a tumor that can be biopsied and measured on ultrasound, agree to see multiple specialists, and not be pregnant or breastfeeding. A clip should already be in place in the primary breast cancer.

Inclusion Criteria

I am fully active or can carry out light work.

Signed written informed consent

My breast cancer is HR+ and HER2- as confirmed by tests.

+4 more

Exclusion Criteria

I am not pregnant or breast-feeding.

I cannot undergo radiotherapy due to health reasons.

Participant Groups

The study is testing if giving radiation therapy before surgery can shrink tumors effectively in patients with specific types of breast cancer. The goal is to potentially reduce the amount of healthy tissue removed during surgery.

1Treatment groups

Experimental Treatment

Group I: Treatment (radiation therapy, surgery)Experimental Treatment2 Interventions

Patients undergo boost radiation therapy 6-8 days before breast surgery. After surgery, patients continue to receive standard of care radiation therapy.

Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

🇪🇺 Approved in European Union as Radiation Therapy for: