Radiation Therapy Duration for Breast Cancer

Recruiting at 14 trial locations

Overseen By Rinaa Punglia, MD MPH

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: T4 cancer, Recurrent breast cancer, Uncontrolled illness, Pregnant, 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: 3-5 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This study is a randomized trial of hypofractionation (short-course) radiation therapy versus conventional radiation therapy in women who have undergone mastectomy and immediate breast reconstruction. The investigators will assess cosmetic and reconstruction outcomes, lymphedema, cancer status, side effects, and oncologic outcomes.

Do I need to stop my current medications for the trial?

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.

Is radiation therapy generally safe for humans?

Radiation therapy, including advanced techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT), has been shown to reduce side effects by better protecting normal tissues. Studies have reported low rates of serious side effects, although some risks remain, such as gastrointestinal and genitourinary toxicities. ^{1 2 3 4 5}

How is radiation therapy for breast cancer different from other treatments?

Radiation therapy for breast cancer, particularly intraoperative radiation therapy (IORT), is unique because it delivers a single dose of radiation directly to the surgical area immediately after tumor removal, potentially reducing the need for prolonged radiation sessions. This approach is especially considered for patients with early-stage breast cancer and favorable tumor characteristics, offering a more targeted treatment with fewer sessions compared to traditional whole-breast irradiation. ^{6 7 8 9 10}

What data supports the effectiveness of this treatment for breast cancer?

Research shows that intraoperative radiotherapy (IORT) can effectively deliver radiation directly to the tumor area, potentially reducing recurrence and improving survival rates for early-stage breast cancer. Additionally, modern radiation techniques, including IORT, have advanced significantly, reducing complications and improving outcomes. ^{8 11 12 13 14}

Who Is on the Research Team?

Julia Wong, MD

Principal Investigator

Dana-Farber Cancer Institute

Rinaa Punglia, MD MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

This trial is for women aged 18 or older who have stage I-III invasive breast cancer, have had a mastectomy and immediate reconstruction with an expander or implant. They should be candidates for unilateral post-mastectomy radiation therapy according to NCCN guidelines. Women with T4 tumors, recurrent breast cancer, prior breast radiation, pregnancy/nursing, uncontrolled illnesses, or certain other cancers are excluded.

Inclusion Criteria

I am eligible for radiation therapy after breast removal surgery according to NCCN guidelines.

My breast cancer is in an early to mid-stage (I-III) and has not spread beyond nearby tissues.

I had reconstructive surgery with an implant or expander right after mastectomy.

Exclusion Criteria

My cancer is at stage T4.

I do not have any severe illnesses that would stop me from joining the study.

Pregnant or nursing

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either hypofractionation or conventional radiation therapy post-mastectomy

3-5 weeks

Daily visits, Monday through Friday

Follow-up

Participants are monitored for safety, effectiveness, and quality of life outcomes after treatment

18 months

Long-term follow-up

Oncologic and clinical outcomes are assessed annually for rare radiation side effects, recurrence, and other clinical outcomes

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Radiation Therapy

Trial Overview The study compares short-course (hypofractionated) radiation therapy versus conventional radiation in terms of cosmetic results after reconstructive surgery following mastectomy, lymphedema incidence, cancer control and side effects. It's randomized so patients don't choose which treatment they get.

How Is the Trial Designed?

Group I: Arm 1: Hypofractionation Experimental Treatment 1 Intervention

16 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 15 fractions to the supraclavicular (with or without axillary) lymph nodes.

Group II: Arm 2: Conventional Radiation Therapy Active Control 1 Intervention

25 fractions of radiation therapy (daily, Monday through Friday) to the chest wall with or without internal mammary nodes, and 23-25 fractions to the supraclavicular (with or without axillary) lymph nodes.

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

Approved in European Union as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in United States as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Canada as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Japan as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in China as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Approved in Switzerland as Radiation Therapy for:

• Cancer treatment
• Palliative care
• Oropharyngeal cancer
• Breast cancer
• Prostate cancer
• Lung cancer
• Brain tumors

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Patient-Centered Outcomes Research Institute

Collaborator

Trials

592

Recruited

27,110,000+

Published Research Related to This Trial

Intraoperative radiotherapy (IORT) for early-stage breast cancer significantly improves radiation-related quality of life (QoL) parameters, with patients reporting less pain and better functioning compared to those receiving external beam radiotherapy (EBRT).

In a study of 230 women, those treated with IORT alone experienced fewer breast and arm symptoms and better overall role functioning, indicating that IORT may be a more patient-friendly option than traditional EBRT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A. Welzel, G., Boch, A., Sperk, E., et al.[2021]

Radiation therapy is crucial in breast cancer treatment, significantly reducing local recurrence and improving survival rates, especially with advancements in techniques since the late 1980s.

Shorter courses of radiation therapy (3-4 weeks) are generally as effective as longer ones, and modern techniques like volumetric modulated arc therapy (VMAT) help minimize complications while enhancing treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evolution of radiotherapy techniques in breast conservation treatment. Boyages, J., Baker, L.[2020]

Intraoperative radiotherapy (IORT) was used in a study involving 1367 patients with 1400 tumors, showing a 5-year local recurrence rate of 5.98% for those receiving IORT only, which is comparable to other IORT studies but higher than standard whole breast radiation therapy (WBRT).

IORT offers benefits such as convenience and low complication rates, making it a viable option for patients meeting specific criteria, although the addition of WBRT was found to significantly reduce the risk of local recurrence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recurrence and Survival Rates for 1400 Early Breast Tumors Treated with Intraoperative Radiation Therapy (IORT). Silverstein, MJ., Epstein, MS., Chen, P., et al.[2022]

In a study of 82 patients with early-stage breast cancer treated with intraoperative radiotherapy (IORT), 72% of those who underwent 21-gene recurrence testing were classified as low risk, indicating that IORT may be suitable for a majority of these patients.

The study highlights a need for further research on the long-term clinical outcomes and safety of IORT, as most patients selected for this treatment were low risk based on their recurrence scores.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

21-gene recurrence assay in patients receiving intraoperative radiotherapy: are "favorable" characteristics a surrogate for low recurrence? Oppong, BA., Sen Gupta, S., Gary, M., et al.[2022]

In a study of 658 patients with high-risk endometrial cancer, intensity-modulated radiation therapy (IMRT) was associated with significantly fewer grade ≥2 adverse events, such as diarrhea and hematologic issues, compared to 3-dimensional conformal radiation therapy (3DCRT) during follow-up.

IMRT also showed a trend towards fewer patient-reported symptoms like bowel urgency and abdominal cramps during treatment, indicating it may provide a better quality of life for patients undergoing radiation therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Radiation Therapy Techniques and Treatment-Related Toxicity in the PORTEC-3 Trial: Comparison of 3-Dimensional Conformal Radiation Therapy Versus Intensity-Modulated Radiation Therapy. Wortman, BG., Post, CCB., Powell, ME., et al.[2022]

In a study of 421 patients undergoing salvage radiotherapy (SRT) after prostate surgery, the use of advanced techniques like intensity-modulated radiotherapy (IMRT) and image-guided radiotherapy (IGRT) significantly reduced the incidence of late gastrointestinal (GI) toxicities to 4.8%.

However, increasing the radiation dose to 68 Gy or more was linked to a higher risk of genitourinary (GU) toxicities, indicating that while advanced techniques can help minimize some side effects, higher doses may still pose risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. Tomita, N., Uchiyama, K., Mizuno, T., et al.[2021]

In a review of 98 phase I radiation therapy trials involving 2994 patients, there were significant risks associated with treatment, including 33 treatment-related deaths and 1812 cases of acute grade 3/4 toxicities, resulting in a median toxicity ratio of 0.46.

Trials that included chemotherapy showed a notably higher toxicity ratio (0.60) compared to those without chemotherapy (0.08), indicating that combining chemotherapy with radiation therapy increases the risk of severe side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phase I trials involving radiation therapy, quantifying the risks. Lawrence, YR., Glass, C., Symon, Z., et al.[2013]

Image-guided radiation therapy (IGRT) has evolved significantly and is now widely used in routine clinical practice, emphasizing the importance of quality and patient safety in its application across various treatment techniques and anatomical sites.

The American Society for Radiation Oncology recommends a comprehensive quality-assurance program and an interdisciplinary team approach to ensure IGRT is performed safely and effectively, highlighting the need for ongoing updates to practice guidelines as technology advances.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. Qi, XS., Albuquerque, K., Bailey, S., et al.[2023]

In a study of 836 prostate cancer patients, those who received image-guided radiotherapy (IGRT) had a 5-year overall survival rate of 88%, which was not significantly different from the 86% survival rate of patients who did not receive IGRT, indicating that IGRT does not negatively impact survival outcomes.

The study found no significant differences in mortality rates from prostate cancer, other cancers, or cardiovascular issues between the IGRT and non-IGRT groups, suggesting that IGRT is a safe option for localized prostate cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of image-guided radiotherapy in definitive radiotherapy for localized prostate cancer: a population-based analysis. Kuo, YH., Liang, JA., Chen, GH., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Radiation-related quality of life parameters after targeted intraoperative radiotherapy versus whole breast radiotherapy in patients with breast cancer: results from the randomized phase III trial TARGIT-A. [2021]

2. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

Evolution of radiotherapy techniques in breast conservation treatment. [2020]

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

Recurrence and Survival Rates for 1400 Early Breast Tumors Treated with Intraoperative Radiation Therapy (IORT). [2022]

4. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

21-gene recurrence assay in patients receiving intraoperative radiotherapy: are "favorable" characteristics a surrogate for low recurrence? [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Patient preferences regarding intraoperative versus external beam radiotherapy for early breast cancer and the impact of socio-demographic factors. [2020]

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

Radiation Therapy Techniques and Treatment-Related Toxicity in the PORTEC-3 Trial: Comparison of 3-Dimensional Conformal Radiation Therapy Versus Intensity-Modulated Radiation Therapy. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Impact of advanced radiotherapy techniques and dose intensification on toxicity of salvage radiotherapy after radical prostatectomy. [2021]

8. Australia pubmed.ncbi.nlm.nih.gov

Phase I trials involving radiation therapy, quantifying the risks. [2013]

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

Quality and Safety Considerations in Image Guided Radiation Therapy: An ASTRO Safety White Paper Update. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Safety of image-guided radiotherapy in definitive radiotherapy for localized prostate cancer: a population-based analysis. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

[Intraoperative radiation therapy in conservative treatment of breast cancer: Quo Vadis?]. [2019]

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

Single institute experience of intraoperative radiation therapy in early-stage breast cancer. [2023]

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

Intraoperative radiation therapy for breast cancer: technical notes. [2022]

14. Germany pubmed.ncbi.nlm.nih.gov

A dosimetric comparison of IORT techniques in limited-stage breast cancer. [2019]