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Radiation Therapy

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

N/A

Waitlist Available

Led By Imran Zoberi, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Invasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular histologies, or mixed histologies (lesions ≤ 2 cm) that are estrogen and/or progesterone receptor positive and do not exhibit HER2/neu gene amplification OR ductal carcinoma in situ (lesions ≤ 2 cm) that are estrogen and/or progesterone receptor positive

All radiation therapy must be planned for delivery at BJH or a BJH/Siteman satellite location with specific stipulations

Must not have

Diagnosis of a coexisting medical condition which limits life expectancy to < 2 years

Prior non-hormonal therapy for the present breast cancer, including radiation therapy or chemotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of two types of radiation therapy for treating early stage breast cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects from APBI may include skin changes like redness or irritation, fatigue, discomfort at the treatment site, swelling or firmness in the treated area of the breast, and rare risks such as rib fracture or secondary cancers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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I am postmenopausal.

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

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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

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My cancer affects my skin.

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I have Paget's disease of the nipple.

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

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My cancer has spread to distant parts of my body.

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

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

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 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

Proportion of patients who are free of breast cancer in the treated breast (IBTR)

Secondary study objectives

Cosmetic Techniques

Change in cosmesis as measured qualitatively by the Aronson modified Harris scale (physician graded)

Change in cosmesis as measured quantitatively by the Breast Retraction Assessment (BRA)

+6 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

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.

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington University School of MedicineLead Sponsor

1,991 Previous Clinical Trials

2,295,750 Total Patients Enrolled

47 Trials studying Breast Cancer

5,092 Patients Enrolled for Breast Cancer

The Foundation for Barnes-Jewish HospitalOTHER

41 Previous Clinical Trials

6,488 Total Patients Enrolled

6 Trials studying Breast Cancer

532 Patients Enrolled for Breast Cancer

Imran Zoberi, M.D.Principal InvestigatorWashington University School of Medicine

5 Previous Clinical Trials

246 Total Patients Enrolled

1 Trials studying Breast Cancer

77 Patients Enrolled for Breast Cancer

Media Library

Accelerated Partial Breast Irradiation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04849871 — N/A

$Breast Cancer Research Study Groups: Arm S_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 20 Gy-1 fraction), Arm F_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 30 Gy-5 fractions)$