External Beam Accelerated Partial Breast Irradiation for Breast Cancer

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Washington University School of Medicine, Saint Louis, MO
Breast Cancer+6 More
External Beam Accelerated Partial Breast Irradiation - Radiation
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a single fraction of radiation therapy is as effective as five fractions for treating breast cancer.

See full description

Eligible Conditions

  • Breast Cancer
  • Stage 0 Breast Cancer
  • Early Breast Cancer
  • Breast Carcinoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether External Beam Accelerated Partial Breast Irradiation will improve 2 primary outcomes and 14 secondary outcomes in patients with Breast Cancer. Measurement will happen over the course of From start of treatment until 6 months post-treatment (estimated to be 6 months).

At 5 years
Occurrence of mastectomy after completion of initial breast-conserving treatment
Proportion of patients who are alive
Proportion of patients who are free of breast cancer in the regional lymph nodes
Proportion of patients who are free of breast cancer in the treated breast (IBTR)
Proportion of patients who are free of distant disease
Year 5
Change in quality of life as measured by EORTC QLQ-BR23
Change in quality of life as measured by EORTC QLQ-C30
Year 5
Change in cosmesis as measured qualitatively by the Aronson modified Harris scale (patient graded)
Change in cosmesis as measured qualitatively by the Aronson modified Harris scale (physician graded)
Change in cosmesis as measured quantitatively by the Percent Breast Retraction Assessment (pBRA)
Year 5
Change in cosmesis as measured quantitatively by the Breast Retraction Assessment (BRA)
Year 5
Proportion of patients who are free of late serious treatment related toxicity
Year 5
Frequency of any CTCAE v5.0 grade 3-4 toxicities
Presence of complications
Month 6
Proportion of patients who are free of acute serious treatment related toxicity
Year 3
Feasibility of treatment regimen as measured by the ability to complete accrual to the trial in 3 years

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Arm F_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 30 Gy-5 ...
1 of 2
Arm S_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 20 Gy-1 ...
1 of 2
Experimental Treatment

This trial requires 130 total participants across 2 different treatment groups

This trial involves 2 different treatments. External Beam Accelerated Partial Breast Irradiation is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Arm F_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 30 Gy-5 fractions)
Radiation
-External Beam APBI 30 Gy in 5 fractions over 5 days.
Arm S_APBI (External Beam Accelerated Partial Breast Irradiation (APBI) 20 Gy-1 fraction)
Radiation
-External Beam APBI 20 Gy to surgical bed surface (7 Gy to 1 cm from surgical bed in 1 fraction)

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: from start of treatment through 5 years (estimated to be 5 years)
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly from start of treatment through 5 years (estimated to be 5 years) for reporting.

Closest Location

Washington University School of Medicine - Saint Louis, MO

Eligibility Criteria

This trial is for female patients aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
A patient with stage 0 or I, histologically confirmed carcinoma of the breast, treated with partial mastectomy, only requires axillary sampling if the tumor size is indeterminate show original
Negative histologic margins of a partial mastectomy or re-excision specimen generally means that the tumor is not present at the edge of the specimen show original
Patients who have undergone neoadjuvant hormone therapy, chemotherapy, or biologic therapy are not allowed to undergo APBI show original
This person is able to understand what they are consenting to and is willing to sign an IRB-approved written informed consent document. show original
Patients eligible for F_APBI or S_APBI at BJH should have their radiation therapy planned for delivery at BJH or a BJH/Siteman satellite location show original
Invasive ductal cancer that is estrogen and/or progesterone receptor positive, without HER2/neu gene amplification, and ductal carcinoma in situ that is estrogen and/or progesterone receptor positive. show original
The patient would be a good candidate for treatment according to the protocol, judged by the PI and/or treating physician following simulation. show original
The state of being postmenopausal. show original
The patient is at least 50 years old when they are diagnosed. show original

Patient Q&A Section

Can breast cancer be cured?

"The treatment options for breast cancer are limited. Early detection can, on average, reduce mortality. However, treatment options are limited and may include surgical, neoadjuvant, or palliative. In terms of mortality rates, the only real cure for breast cancer appears to be complete remission." - Anonymous Online Contributor

Unverified Answer

What are common treatments for breast cancer?

"Currently, there is no cure for [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer), so treatment is focused on symptom management and is highly dependent on the specific patient. Treatment modalities may include surgery, chemotherapy, radiation, medical therapy, hormonal therapy, medical therapy, biological therapy, or a combination of the above. Breast cancer surgery is often combined with breast- saving radiotherapy that is focused to shrink the cancer. Chemotherapy, either alone or in combination with other forms of treatment can significantly shrink certain types of cancer. Medical therapy and hormone therapy may be prescribed to control tumor growth. Oncologists can also prescribe medical therapy that aims to kill breast cancer cells. There are many types of medical therapy." - Anonymous Online Contributor

Unverified Answer

What causes breast cancer?

"While most studies report associations, they suggest cause-and-effect relationships only in a minority of cases.  A review of what is known as the "causes of breast cancer" provides an overview of associations that can provide a plausible explanation for the observed findings. Although there has been little research or consensus about what causes breast cancer, our understanding of risk factors, disease progression, and treatment has been greatly improved by the discovery of a significant number of breast cancer genes.\n\n- "Genetics Home Reference". New York: DK Publishing, 2003. p. 98.\n- "Cancer: Causes and Prevention". Berkeley, Calif." - Anonymous Online Contributor

Unverified Answer

What is breast cancer?

"Breast cancer is a cancer that forms in glandular tissues, called breast. Breast cancers are frequently associated with painful sex and with bleeding from the nipples. Breast cancers are also the most frequent form of cancer in people who are middle-aged." - Anonymous Online Contributor

Unverified Answer

What are the signs of breast cancer?

"Breast cancer may present with a number of suggestive signs and symptoms. Most commonly, painless irregular masses are seen. Other signs of [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer) include skin changes such as unexplained or painful changes, nipple discharge, or redness or heat sensation in the areola of the nipple. Other signs include unexplained fatigue or pain, unexplained weight loss or weakness, or a history of a history of being diagnosed or treated for another type of cancer. Diagnosis of breast cancer and appropriate treatment of breast cancer are both best achieved by a doctor who has special knowledge of breast and breast cancer. Most importantly, the signs of breast cancer will be present at diagnosis. Signs of metastatic disease are not necessarily present on time, or are not the only cause of symptoms." - Anonymous Online Contributor

Unverified Answer

Does breast cancer run in families?

"Findings from a recent study provide a new evidence that familial predisposition to breast cancer runs in families from a genetic point of view. A new set of markers may be of great use for the risk of breast cancer development in relation to familial predisposition and of interest in the diagnostic paradigm." - Anonymous Online Contributor

Unverified Answer

What are the common side effects of external beam accelerated partial breast irradiation?

"The common side effects of external beam APBI are similar to those of whole breast RT of daily fractions. The most prevalent side effects were erythema, dermatitis, swelling, and edema in the breast and/or arm. The side effects of APBI are much less severe than those of whole breast RT." - Anonymous Online Contributor

Unverified Answer

What is the latest research for breast cancer?

"The current research is the best option for women with [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). The advancement in technology like MRI, ultrasound and PET-CT scanning, gene and hormone therapy and immunotherapy have all shown the possibility to cure people with breast cancer. It just depends on which way it works, and most importantly, when. But to reach that goal will take decades and decades and decades and decades. This is why cancer remains so devastating for young and old women alike.\n" - Anonymous Online Contributor

Unverified Answer

How does external beam accelerated partial breast irradiation work?

"The data provided preliminary evidence of benefit for patients who underwent EBRT after neoadjuvant chemotherapy for early-stage [breast cancer](https://www.withpower.com/clinical-trials/breast-cancer). EBRT was found to reduce relapse and mortality rates in these patients when compared with localised breast-conserving therapy." - Anonymous Online Contributor

Unverified Answer

Have there been any new discoveries for treating breast cancer?

"All of the studies suggested that there is still a lot of research to do, especially in terms of a better understanding of the genes that may be involved in breast cancer. The data has also pointed out that more emphasis has to be put into identifying the causes of breast cancer, such as environmental factors, and the influence they may have on the disease. Also, for more studies to be conducted, bigger and longer cohorts have to be gathered. A more balanced approach, one that is more encompassing of all the research topics may lead to better results. While most people think that there are no possibilities for preventing breast cancer, a balanced approach has created a better understanding in which to think." - Anonymous Online Contributor

Unverified Answer

What is external beam accelerated partial breast irradiation?

"In a recent study, findings, we did not find an improvement in efficacy or morbidity at 3 years compared with standard fractionated, 3-field rate-Modified APBI, using IMRT. However, IMRT decreased the radiation dose delivered to the heart and lung and the length of the treatment time." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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