Re-irradiation for Breast Cancer

(BRASIL Trial)

Recruiting at 1 trial location

Overseen By Youssef Zeidan, M.D., Ph.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Baptist Health South Florida

Disqualifiers: BRCA1/2 mutation, Pregnancy, Metastasis, others

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

Compensation: Varies

Number of Visits: Unknown

114 Participants Needed

Trial Summary

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 team or your doctor.

What data supports the effectiveness of the treatment Intensity modulated radiation therapy (IMRT) for breast cancer?

Research shows that IMRT can improve the way radiation is distributed in the breast, reducing exposure to nearby healthy tissues like the heart and lungs. This can lead to better treatment outcomes and fewer side effects for breast cancer patients. ^{1 2 3 4 5}

Is re-irradiation for breast cancer using IMRT generally safe for humans?

IMRT is generally considered safe and is widely used for various conditions, including breast cancer. It allows for precise targeting of radiation, reducing exposure to healthy tissue, but requires careful planning and safety checks. Some studies show it reduces skin side effects compared to traditional methods. ^{6 7 8 9 10}

How is intensity-modulated radiation therapy (IMRT) different from other treatments for breast cancer?

Intensity-modulated radiation therapy (IMRT) is unique because it allows for highly precise targeting of radiation doses, which can improve treatment effectiveness and reduce side effects compared to traditional radiation therapy. This precision is particularly beneficial in re-irradiation scenarios, where minimizing damage to surrounding healthy tissue is crucial. ^{2 6 11 12 13}

What is the purpose of this trial?

The purpose of this research study is to test the safety and possible harms of treating breast cancer with reirradiation, after breast surgery. The researchers want to find out what effects (good and bad) reirradiation has on people who have already received radiation before surgery.

Research Team

Youssef Zeidan, M.D., Ph.D.

Principal Investigator

Lynn Cancer Institute at Baptist Health, Inc.

Eligibility Criteria

This trial is for individuals who have had breast cancer and are undergoing a second lumpectomy. It's specifically for those who've already received radiation therapy before surgery and are now considering reirradiation.

Inclusion Criteria

Stated willingness to comply with all study procedures and availability for the duration of the study

I am 40 years old or older.

My breast cancer is ER positive and HER2 negative.

Exclusion Criteria

My cancer affects my skin.

I have no other cancers except possibly skin cancer.

Pregnancy or breastfeeding

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo breast surgery prior to reirradiation

Not specified

Reirradiation Treatment

Participants receive reirradiation treatment to test safety and possible harms

Not specified

Follow-up

Participants are monitored for adverse events and survival outcomes

5 years

Treatment Details

Interventions

• Intensity modulated radiation therapy (IMRT)

Trial Overview The study is examining the safety of Intensity Modulated Radiation Therapy (IMRT) as a form of reirradiation in patients who have previously undergone radiation treatment for breast cancer following their second lumpectomy.

Participant Groups

Group I: Partial Breast Irradiation (PBI) Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Baptist Health South Florida

Lead Sponsor

Trials

54

Recruited

8,100+

Boca Raton Regional Hospital Foundation

Collaborator

Trials

1

Recruited

110+

Findings from Research

Intensity Modulated Radiation Therapy (IMRT) is now the primary technique for delivering radiation treatment, allowing for higher doses to be targeted precisely while protecting surrounding healthy tissue.

The updated consensus emphasizes the importance of quality and safety in IMRT planning and delivery, requiring a team-based approach and comprehensive quality assurance programs to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality and Safety Considerations in Intensity Modulated Radiation Therapy: An ASTRO Safety White Paper Update. Moran, JM., Bazan, JG., Dawes, SL., et al.[2023]

A longitudinal study involving 727 breast cancer patients found that while patients initially reported worse toxicity symptoms at 6 months post-radiotherapy, these symptoms improved significantly over time, indicating a positive trend in patient-reported outcomes (PROMs).

Despite using intensity-modulated radiotherapy (IMRT), the study did not find significant benefits in PROMs compared to standard radiotherapy at 5 years, suggesting that factors such as breast volume, age, and surgical outcomes play a crucial role in patient experiences post-treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reported outcome measures (PROMs) following forward planned field-in field IMRT: results from the Cambridge Breast IMRT trial. Mukesh, MB., Qian, W., Wilkinson, JS., et al.[2022]

References

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

Radiotherapy is a safe and effective salvage treatment for recurrent cervical cancer. [2018]

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

Optimizing breast cancer treatment efficacy with intensity-modulated radiotherapy. [2019]

3. France pubmed.ncbi.nlm.nih.gov

Intensity modulated radiation therapy with simultaneous integrated boost in early breast cancer irradiation. Report of feasibility and preliminary toxicity. [2022]

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

Long-term outcomes in breast cancer patients with ten or more positive axillary nodes treated with combined-modality therapy: the importance of radiation field selection. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Intensity-modulated radiotherapy for breast cancer: advances in whole and partial breast treatment. [2019]

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

Prospective trial of accelerated partial breast intensity-modulated radiotherapy. [2018]

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

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

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

Dosimetric Comparison of Hypofractionated Regimen in Breast Cancer Using Two Different Techniques: Intensity-Modulated Radiation Therapy (IMRT) and Volumetric-Modulated Arc Therapy (VMAT). [2023]

9. Ireland pubmed.ncbi.nlm.nih.gov

Patient reported outcome measures (PROMs) following forward planned field-in field IMRT: results from the Cambridge Breast IMRT trial. [2022]

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

A multicenter randomized trial of breast intensity-modulated radiation therapy to reduce acute radiation dermatitis. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Local recurrence of breast cancer: conventionally fractionated partial external beam re-irradiation with curative intention. [2022]

12. Greece pubmed.ncbi.nlm.nih.gov

Inter-institutional Variation in Intensity-modulated Radiotherapy for Breast Cancer in Korea (KROG 19-01). [2021]

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

Intensity modulated radiation therapy for breast cancer: current perspectives. [2022]