Radiation Therapy for Breast Cancer

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

137 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment External Beam Radiation Therapy (EBRT) for breast cancer?

External Beam Radiation Therapy (EBRT) has been shown to be effective in treating various cancers, such as prostate cancer, by improving survival rates and reducing cancer recurrence. While this data is specific to prostate cancer, it suggests that EBRT can be a powerful tool in managing cancer, potentially including breast cancer. ^{1 2 3 4 5}

Is external beam radiation therapy (EBRT) generally safe for humans?

EBRT is generally considered safe, but it can cause side effects like pain flare, which occurs in 16-41% of patients who haven't taken steroids. This information is based on studies involving EBRT for conditions like bone metastases. ^{1 4 6 7 8}

How does external beam radiation therapy (EBRT) for breast cancer differ from other treatments?

External beam radiation therapy (EBRT) is unique because it is a non-invasive treatment that uses high-energy rays to target and destroy cancer cells in the breast, often as part of breast-conserving therapy. Unlike some other treatments, EBRT can be extended to target additional areas like the supraclavicular fossa and internal mammary chain, providing comprehensive coverage for high-risk patients. ^{1 8 9 10 11}

What is the purpose of this trial?

Single-arm, phase 2 study evaluating hypofractionated irradiation of breast and regional nodes in women with breast cancer. Patients will be grouped in 3 surgery-related treatment groups: 1) An intact breast following lumpectomy; 2) plans for loco regional external beam radiotherapy (EBRT) following mastectomy (with or without plans for reconstruction); and 3) plans for locoregional EBRT following mastectomy with reconstruction. Patients will be assessed for lymphedema, arm function, breast or chestwall pain, other EBRT-related adverse events, and, for patients who had a lumpectomy or mastectomy with reconstruction, cosmetic outcome.

Research Team

Douglas W Arthur, M.D.

Principal Investigator

Massey Cancer Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Single fraction radiotherapy versus multiple fraction radiotherapy for bone metastases in prostate cancer patients: comparative effectiveness. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Learning in 360 Degrees: A Pilot Study on the Use of Virtual Reality for Radiation Therapy Patient Education. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

5. United States 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. [2021]

6. China 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). [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Contemporary Toxicity Profile of Breast Brachytherapy Versus External Beam Radiation After Lumpectomy for Breast Cancer. [2022]

8. India pubmed.ncbi.nlm.nih.gov

Fractionated beam radiotherapy is a special case of continuous beam radiotherapy when irradiation time is small. [2018]

9. Germany pubmed.ncbi.nlm.nih.gov

[Intraoperative radiotherapy (IORT) in treatment of breast carcinoma--a new therapeutic alternative within the scope of breast-saving therapy? Current status and future prospects. Report of experiences from the European Institute of Oncology (EIO), Mailand]. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Radiotherapy of Breast Cancer in Laterally Tilted Prone vs. Supine Position: What about the Internal Mammary Chain? [2022]

11. United States 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. [2023]