Accelerated Partial Breast Irradiation for Early-Stage Breast Cancer (BreaStBRT Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByImran Zoberi, M.D.

Age: 18+

Sex: Female

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Washington University School of Medicine

No Placebo Group

Approved in 3 jurisdictions

Trial Summary

What is the purpose of this trial?This study will evaluate the local control, complication rates, cosmetic results, and quality of life between patients treated with a single fraction vs. five fractions of accelerated partial breast irradiation (S_APBI vs. F_APBI) when used as the sole method of radiation therapy.

Eligibility Criteria

This trial is for postmenopausal women over 50 with early-stage breast cancer (Stage 0 or I) that's hormone receptor-positive and HER2/neu gene negative. Candidates must have had a partial mastectomy with clear margins, no positive lymph nodes, and not received prior non-hormonal therapy for the current cancer. They should be in good health without life-limiting conditions.

Inclusion Criteria

My breast cancer is hormone receptor positive and not HER2 positive, or it is a non-invasive type that is hormone receptor positive.

My radiation therapy will be done at BJH or its specific locations.

I am postmenopausal.

My breast cancer has not spread to my underarm lymph nodes, confirmed by tests.

My breast cancer was early stage (0 or I) and treated with a lumpectomy.

My breast surgery removed all the cancer that could be seen.

I was 50 years or older when my condition was diagnosed.

Exclusion Criteria

I have a health condition that may limit my life to less than 2 years.

I have had treatments like radiation or chemotherapy for my current breast cancer.

My surgery showed cancer cells at the edge of the removed tissue.

My cancer affects my skin.

I have Paget's disease of the nipple.

I have suspicious lymph nodes near my collarbone or breastbone that have been tested and are not cancerous.

My cancer has spread to distant parts of my body.

My breast cancer is not the common type but rather a rare form like sarcoma or lymphoma.

I have multiple tumors in one breast, confirmed not cancerous by biopsy if there were suspicious areas.

My cancer has spread to the lymph nodes under my arm on the same side as my breast cancer.

My partial mastectomy has left me with a fair or poor appearance as judged by my doctor.

I have been diagnosed with lupus, scleroderma, or dermatomyositis.

Participant Groups

The study compares two radiation therapies after breast-conserving surgery: one single fraction vs. five fractions of accelerated partial breast irradiation (APBI). It aims to assess which method better controls cancer, has fewer complications, yields better cosmetic results, and improves quality of life.

2Treatment groups

Experimental Treatment

Group I: Arm S_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 20 Gy-1 fraction)Experimental Treatment1 Intervention

-External Beam APBI 20 Gy to surgical bed surface (7 Gy to 1 cm from surgical bed in 1 fraction)

Group II: Arm F_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 30 Gy-5 fractions)Experimental Treatment1 Intervention

-External Beam APBI 30 Gy in 5 fractions over 5 days.

Accelerated Partial Breast Irradiation is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as APBI for: