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: Youssef Zeidan

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety of re-irradiation, a focused radiation treatment, for breast cancer patients who previously received radiation before surgery. The main goal is to determine the effects, both positive and negative, of using this treatment again after surgery. It specifically seeks individuals with ER+HER2- breast cancer, a history of radiation treatment, and no certain genetic mutations or other complicating factors. Participants should have experienced a local recurrence on the same side as their initial cancer. As an unphased trial, this study allows patients to contribute to understanding the safety of re-irradiation in a unique context.

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 prior data suggests that reirradiation is safe for breast cancer patients?

Research has shown that intensity modulated radiation therapy (IMRT) for breast cancer is generally well-tolerated. Studies have found that patients receiving IMRT experienced less skin irritation than those treated with other radiation types. Long-term follow-ups indicate that IMRT effectively controls cancer and leads to good overall outcomes for patients.

Importantly, patients did not face a higher risk of developing a second cancer compared to other radiation methods, suggesting that IMRT is relatively safe for treating breast cancer. However, like any treatment, side effects can occur, so discussing these with a doctor is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about intensity modulated radiation therapy (IMRT) for breast cancer re-irradiation because it provides a more precise delivery of radiation, minimizing damage to surrounding healthy tissues. Unlike traditional radiation therapy, which can affect a broader area, IMRT uses advanced technology to target only the cancerous parts of the breast. This precision potentially leads to fewer side effects and better preservation of healthy tissue, making it a promising option for patients who need re-irradiation.

What evidence suggests that reirradiation might be an effective treatment for breast cancer?

Research has shown that intensity modulated radiation therapy (IMRT) effectively treats breast cancer. Studies have found that using IMRT on the whole breast results in a very low chance of cancer returning within five years. Patients report that the treated area maintains a good appearance after treatment, with minimal long-term side effects. A large study found that adding radiation therapy can reduce the risk of cancer recurrence by up to 15%. In this trial, participants will receive IMRT as Partial Breast Irradiation (PBI) to evaluate its effectiveness in managing breast cancer after surgery. ^{1 5 6 7 8}

Who Is on the Research Team?

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

Principal Investigator

Lynn Cancer Institute at Baptist Health, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

Youssef Zeidan

Lead Sponsor

Baptist Health South Florida

Lead Sponsor

Trials

54

Recruited

8,100+

Boca Raton Regional Hospital Foundation

Collaborator

Trials

1

Recruited

110+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9629965/

Intensity Modulated Radiotherapy and Volumetric ... Compared with 3D-CRT, IMRT for breast cancer increases the low-dose area outside the target volume, which potentially increases the risk of secondary malignancy ...

2. redjournal.org redjournal.org/article/S0360-3016(12)00142-3/abstract

Five-year Results of Whole Breast Intensity Modulated ... Whole-breast IMRT is associated with very low rates of local recurrence at 5 years, 83%-98% “good/excellent” cosmetic outcomes, and minimal chronic toxicity, ...

3. nejm.org nejm.org/doi/full/10.1056/NEJMoa2207586

Breast-Conserving Surgery with or without Irradiation in ... Overall survival at 10 years was almost identical in the two groups, at 80.8% (95% CI, 77.2 to 84.3) with no radiotherapy and 80.7% (95% CI, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301612001423

Five-year Results of Whole Breast Intensity Modulated ... Whole-breast IMRT is associated with very low rates of local recurrence at 5 years, 83%-98% “good/excellent” cosmetic outcomes, and minimal chronic toxicity, ...

5. nature.com nature.com/articles/s41598-019-39469-8

Intensity-modulated radiation therapy with simultaneous ... A meta-analysis of data from over 10,000 women revealed that adjuvant radiotherapy reduces risk of recurrence by up to 15% and 15-year mortality ...

6. nature.com nature.com/articles/s41598-020-61403-6

Five-year survival outcomes of intensity-modulated ... For the entire cohort, the 5-year and 7-year overall survival (OS) rates were 94.4% and 93.1% respectively. The 7-year distant metastasis-free ...

7. redjournal.org redjournal.org/article/S0360-3016(23)00523-0/fulltext

5-Year Results of the IMRT-MC2 Phase III Trial Five years after radiation therapy, the LC rate for the IMRT-SIB arm was 98.7% versus 98.3% for the 3D-CRT-seqB arm, with 3 and 5 local ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301608004203

Long-Term Outcomes of IMRT for Breast Cancer Patients treated with breast IMRT had decreased acute skin toxicity, and long-term follow-up shows excellent local control similar to a contemporaneous cohort ...