Radiation Therapy for Breast Cancer

Not currently recruiting at 1 trial location

Overseen By Massey CTO Operations Managers

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Metastatic disease, T4 tumors, N2/N3 disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 6 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3-4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a special type of radiation therapy called External Beam Radiation Therapy (EBRT) for women who have undergone surgery for breast cancer. The goal is to assess how well this treatment reduces unwanted side effects such as lymphedema (swelling), arm function issues, and pain, while also evaluating cosmetic outcomes for those who had breast reconstruction. Women who have had surgery to remove breast cancer and are not currently experiencing major complications may be suitable candidates for this trial. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance post-surgical outcomes for future breast cancer patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this radiation therapy is safe for breast cancer patients?

Research has shown that external beam radiation therapy (EBRT) is generally safe for breast cancer patients. Some studies have found that radiation therapy can improve quality of life compared to treatments like hormone therapy. However, there are risks. Older research suggested an increased risk of heart problems for those receiving radiation on the left side of the chest, but newer techniques aim to reduce these risks.

Common side effects of EBRT include skin irritation and changes in breast tissue. Long-term effects might include breast fibrosis, where the breast tissue becomes hard or firm. Despite these risks, EBRT remains a common and well-tolerated treatment option in breast cancer care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about External Beam Radiation Therapy (EBRT) for breast cancer because it offers a potentially more convenient treatment timeline. Unlike traditional radiation therapy, which often requires daily sessions over five to seven weeks, EBRT uses a hypofractionated approach, delivering higher doses over just three to four weeks. This shorter schedule could mean less disruption to patients' lives while maintaining effectiveness. Additionally, EBRT specifically tailors treatment based on the type of axillary surgery and breast surgery patients undergo, allowing for a more personalized approach.

What evidence suggests that External Beam Radiation Therapy is effective for breast cancer?

Research has shown that external beam radiation therapy (EBRT), which participants in this trial will receive, is highly effective for treating breast cancer. One study found that 98.5% of patients with early-stage breast cancer who received EBRT had positive results. Patients treated with EBRT often experience good long-term outcomes, including a reduced risk of cancer recurrence. Studies have also compared EBRT with other treatments and consistently found it to be a reliable choice. However, some risks exist, such as potential heart-related side effects, especially for cancer on the left side of the breast. Overall, EBRT remains a trusted option for many breast cancer patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Douglas W Arthur, M.D.

Principal Investigator

Massey Cancer Center

Are You a Good Fit for This Trial?

This trial is for women with breast cancer who've had surgery, have healed incisions without infection, and tested ER, PR, HER2 on the tumor. They must understand English consent forms, not be pregnant or breastfeeding, use birth control during the study, and meet specific criteria related to their cancer stage and treatment history.

Inclusion Criteria

My breast cancer is confirmed as invasive adenocarcinoma.

My surgical wound has healed without any infection.

I am not pregnant, as confirmed by a test, and I am not postmenopausal or have not had a hysterectomy.

Exclusion Criteria

I have had breast cancer or DCIS on either side and received radiation therapy.

I have had surgery on the same or opposite side armpit before.

My breast cancer is advanced (T4) or inflammatory.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo hypofractionated regional nodal irradiation (RNI) five days a week over 3-4 weeks

3-4 weeks

Daily visits (in-person) for radiation therapy

Follow-up

Participants are monitored for lymphedema, arm function, pain, and other adverse events every 6 months

3 years

Biannual visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• External Beam Radiation Therapy

Trial Overview

The study tests hypofractionated irradiation therapy in women post-breast surgery. It's a phase 2 trial where patients are grouped based on their surgical status: after lumpectomy; post-mastectomy with/without reconstruction plans; or post-mastectomy with reconstruction. Outcomes like lymphedema and pain will be monitored.

How Is the Trial Designed?

Group I: Treatment (EBRT) Experimental Treatment 3 Interventions

External Beam Radiation Therapy (EBRT). Within 10 weeks after the last breast cancer surgery or the last dose of adjuvant chemotherapy, patients undergo hypofractionated RNI five days a week over 3-4 weeks. The two subgroups are Cohort (A) sentinel lymph node (SLN) and Cohort (B) axillary lymph node (ALN) dissection. They are categorized depending on type of axillary surgery and treatment group. The type of axillary surgery is Sentinel lymph node (SLN) biopsy only vs axillary dissection with or without previous SLN biopsy. The treatment groups are lumpectomy vs mastectomy vs mastectomy/reconstruction.

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

Approved in European Union as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in United States as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in Canada as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in Japan as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in China as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Approved in Switzerland as External Beam Radiation Therapy for:

• Various types of cancer, including but not limited to breast, lung, prostate, and brain cancers

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Published Research Related to This Trial

A pilot study involving seven patients found that while traditional education methods for external beam radiation therapy (EBRT) were satisfactory, 86% of participants felt they did not fully capture the treatment experience.

The introduction of a 360-degree virtual reality (VR) video as a supplemental educational tool showed potential benefits, including improved understanding of the treatment process and reduced anxiety, especially when viewed before the first treatment session.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning in 360 Degrees: A Pilot Study on the Use of Virtual Reality for Radiation Therapy Patient Education. Johnson, K., Liszewski, B., Dawdy, K., et al.[2021]

In a study of 32 patients receiving External Beam Radiotherapy (EBRT) for bone metastases, 41% experienced a pain flare, which is defined as a significant increase in pain or analgesia intake, with a median duration of 3 days.

The incidence and duration of pain flare observed in this study align with findings from international studies, indicating that pain flare is a common side effect of EBRT for bone metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An investigation into the incidence of pain flare in patients undergoing radiotherapy for symptomatic bone metastases. Goldfinch, R., White, N.[2018]

Brachytherapy for breast cancer was associated with a higher risk of both infectious and noninfectious adverse events compared to external beam radiation therapy (EBRT), with odds ratios of 1.21 and 2.27 respectively, indicating a significant difference in safety profiles.

Over time, the incidence of infectious complications after brachytherapy decreased, while noninfectious complications, particularly seromas, increased, suggesting improvements in technique and experience may be influencing outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contemporary Toxicity Profile of Breast Brachytherapy Versus External Beam Radiation After Lumpectomy for Breast Cancer. Huo, J., Giordano, SH., Smith, BD., et al.[2022]

Black men with prostate cancer had higher rates of treatment noncompletion when receiving conventional external-beam radiation therapy compared to White men, but this disparity was not observed with shorter radiation regimens like stereotactic body radiotherapy (SBRT) or moderate hypofractionation (mEBRT).

For women with breast cancer, shorter hypofractionated external-beam radiation therapy (hEBRT) was associated with lower treatment noncompletion rates compared to conventional therapy, yet Black women were less likely to receive hEBRT despite its increasing availability and potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shorter Radiation Regimens and Treatment Noncompletion Among Patients With Breast and Prostate Cancer in the United States: An Analysis of Racial Disparities in Access and Quality. Dee, EC., Taunk, NK., Chino, FL., et al.[2023]

Fractionated beam radiotherapy (EBRT) and brachytherapy, while different in technique, can achieve similar biological effective doses (BED) under certain conditions, particularly with short irradiation times.

This study uses mathematical models to demonstrate the correlation between these two radiotherapy methods, suggesting that they may have comparable effects on tumor control and tissue response.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fractionated beam radiotherapy is a special case of continuous beam radiotherapy when irradiation time is small. Biswas, J., Rajguru, TK., Choudhury, KB., et al.[2018]

Patients with asymptomatic bone metastases who received external beam radiation therapy (EBRT) experienced a significant delay in the onset of moderate-to-severe pain and skeletal-related events (SREs), with a median time of 81 months compared to 25 months for untreated patients (P<0.001).

EBRT was particularly effective in delaying pain and SREs in prostate and lung cancer patients, although it did not show the same benefit for breast cancer patients, and it did not affect overall survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External beam radiation therapy (EBRT) for asymptomatic bone metastases in patients with solid tumors reduces the risk of skeletal-related events (SREs). Shulman, RM., Meyer, JE., Li, T., et al.[2020]

External-beam radiotherapy (EBRT) has been effectively used for over 30 years to treat prostate adenocarcinoma, demonstrating significant improvements in cause-specific survival and freedom from PSA progression.

Recent advancements in radiation techniques have enhanced the safety and efficacy of EBRT, making it a viable treatment option for early-stage, locally advanced, and metastatic prostate cancer, while managing side effects effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

External-beam radiotherapy in the management of carcinoma of the prostate. Zlotecki, RA.[2017]

External beam radiotherapy (EBRT) is an effective treatment for relieving symptoms caused by bone metastases in prostate cancer patients.

This review specifically compares the effectiveness of single fraction radiotherapy to multiple fraction radiotherapy, highlighting the need for further analysis on which approach may provide better outcomes for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single fraction radiotherapy versus multiple fraction radiotherapy for bone metastases in prostate cancer patients: comparative effectiveness. Yoon, F., Morton, GC.[2020]

In a study of 54,642 prostate cancer patients, low-dose-rate brachytherapy boost (LDR-BB) was associated with significantly higher gastrointestinal (GI) toxicity (32.3%) compared to high-dose-rate brachytherapy boost (HDR-BB) (16.7%) and external beam radiation therapy (EBRT) monotherapy (18.7%).

High-dose-rate brachytherapy boost (HDR-BB) resulted in lower incidences of skeletal-related events (2.4%) and prostate cancer-specific mortality (2.7%) compared to EBRT monotherapy (2.8% and 3.5%, respectively), indicating HDR-BB may offer better long-term outcomes in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of High-Dose-Rate and Low-Dose-Rate Brachytherapy Boost on Toxicity, Functional and Cancer Outcomes in Patients Receiving External Beam Radiation Therapy for Prostate Cancer: A National Population-Based Study. Parry, MG., Nossiter, J., Sujenthiran, A., et al.[2021]

Citations

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Intraoperative radiotherapy versus ... - Breast Cancer Research

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Large phase III trial shows patients report excellent outcomes after either treatment, with differences in preference favoring protons.

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ASTRO corrects media misinformation on breast cancer ...

While acute skin toxicity is less severe with IORT compared to external beam radiation, long-term toxicity such as breast fibrosis is ...

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cancernetwork.com

cancernetwork.com/view/exclusive-radiation-therapy-improves-qol-and-safety-outcomes-in-breast-cancer

Exclusive Radiation Therapy Improves QOL and Safety ...

When compared with endocrine therapy, radiation therapy improved quality of life and adverse effects data, the phase 3 EUROPA study showed.

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redjournal.org

redjournal.org/article/S0360-3016(25)03353-X/fulltext

Safety and Early Outcomes of External Beam Radiation ...

Here, we retrospectively report the safety and early efficacy of using EBRT and low-dose-rate (LDR) brachytherapy boost with or without androgen ...

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Real World Safety of Adjuvant Ultra Hypofractionated ...

Adjuvant radiotherapy (RT) improves local control and progression-free survival rates after conservative or radical surgery in breast cancer.2,3 ...