PBI Radiotherapy for Breast Cancer

Overseen By Carmen Perez, M.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: NYU Langone Health

Disqualifiers: Previous radiation, Extensive intraductal, others

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

Compensation: Varies

Number of Visits: 5

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines two different radiotherapy schedules to treat breast cancer, aiming to determine which is safer and more effective. One schedule delivers radiation over five consecutive days, while the other administers it every other day for five days. Post-menopausal women who have had a certain type of low-risk, small breast cancer removed may be suitable candidates. As an unphased trial, it provides a unique opportunity to contribute to research that could enhance future breast cancer treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Partial Breast Irradiation (PBI) treatments, like those being tested, are generally easy for patients to handle. Studies on PBI radiotherapy at 6 Gy have found it effectively controls breast cancer with lasting results. Some studies suggest it works as well as whole breast irradiation in preventing cancer recurrence in the same breast. Although reports on side effects vary, many studies indicate it can be used safely with few long-term issues.

For the 8 Gy treatment, research also shows it controls cancer well and has few long-term side effects. These studies suggest that PBI can help maintain the breast's appearance after treatment.

In summary, both the 6 Gy and 8 Gy PBI treatments are considered safe, with most studies showing they are well-tolerated by patients. However, since some studies report mixed results on side effects, discussing any concerns with the trial team is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about PBI Radiotherapy for breast cancer because it offers a more precise and potentially quicker treatment option compared to traditional whole breast irradiation. Unlike standard treatments, which often require several weeks, PBI Radiotherapy condenses treatment into just five days, targeting only the affected part of the breast. The 6 Gy arm delivers radiation over five consecutive days, while the 8 Gy arm administers a higher dose every other day over the same period. This focused approach not only reduces the overall treatment time but also aims to minimize exposure to surrounding healthy tissues, potentially leading to fewer side effects.

What evidence suggests that this trial's radiotherapy regimens could be effective for breast cancer?

Previous studies have shown promising results for partial breast irradiation (PBI) in treating early-stage breast cancer. Research indicates that PBI, such as the 6 Gy treatment plan, effectively controls cancer locally and reduces the chance of recurrence after surgery, similar to whole breast irradiation. In this trial, participants may receive either the 6 Gy or the 8 Gy treatment plan. Studies have found that PBI causes fewer immediate side effects compared to whole breast irradiation, making it easier on the body. Researchers are exploring the 8 Gy treatment plan for its potential to maintain these benefits while requiring fewer treatment sessions. These findings support using PBI as an effective way to target breast cancer while minimizing harm to healthy tissue. ^{1 2 4 6 7}

Who Is on the Research Team?

Naamit K Gerber, MD

Principal Investigator

NYU Langone Medical Center

Are You a Good Fit for This Trial?

This trial is for post-menopausal women with a specific early-stage breast cancer (pT1), who have had the tumor surgically removed with clear margins and no spread to lymph nodes. Women must not have had previous radiation on the same breast or a high proportion of DCIS, which suggests extensive intraductal component.

Inclusion Criteria

My breast cancer has not spread to my lymph nodes.

I am a post-menopausal woman, confirmed by lack of periods, age, or tests.

My breast cancer was removed with clear margins.

Exclusion Criteria

I have had radiation therapy on the same side breast before.

The biopsy shows a large amount of a specific type of abnormal cells in the milk ducts.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive prone partial breast irradiation with either 8 Gy x 3 over 5 days or 6 Gy x 5 over 5 days

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PBI Radiotherapy 6 Gy
• PBI Radiotherapy 8 Gy

Trial Overview The study is comparing two different doses of partial breast irradiation (PBI) radiotherapy in treating breast cancer: one group receives 8 Gy over three sessions every other day for five days, while another gets 6 Gy over five consecutive days. The goal is to see if the higher dose given less frequently is as safe and effective.

How Is the Trial Designed?

Group I: PBI Radiotherapy 8 Gy Experimental Treatment 1 Intervention

Prone partial breast irradiation of 8 Gy x 3 over 5 days, every other day

Group II: PBI Radiotherapy 6 Gy Experimental Treatment 1 Intervention

Prone partial breast irradiation of 6 Gy x 5 over 5 days, on five consecutive days

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

In a phase II trial involving 73 early-stage breast cancer patients, the external beam partial breast irradiation (PBI) regimen of 35 Gy in 7 daily fractions was found to be well-tolerated, with no Grade 3 toxicity reported and only minor side effects observed.

The treatment demonstrated high efficacy, achieving a 98% local control rate and a 96.7% rate of freedom from distant metastases over a median follow-up of 40 months, indicating it is a safe and effective option for patients aged 60 and older.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Seven fractions to deliver partial breast irradiation: the toxicity is Low. Trovo, M., Avanzo, M., Vinante, L., et al.[2018]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S1879850025000980

Partial Breast Radiation Therapy in Low-Risk ... Previous studies on PBI demonstrated similar ipsilateral breast tumor recurrences compared with whole breast irradiation, however, conflicting data on toxicity ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7492676/

Long-Term Results of Partial Breast Irradiation After ... From the results of our study, it was suggested that for the early stage breast cancer patients, PBI had durable local control and maintained ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10483267/

Partial breast irradiation compared with whole breast irradiation Among women with early-stage breast cancer who undergo lumpectomy, adjuvant breast radiotherapy reduces both recurrence and breast cancer mortality (3).

4. practicalradonc.org practicalradonc.org/article/S1879-8500(23)00296-5/fulltext

Partial Breast Irradiation for Patients With Early-Stage ... Studies included adult patients with early-stage invasive breast cancer +/– DCIS who received 1 of 6 PBI modalities (MIB, single-entry catheter ...

5. nature.com nature.com/articles/s41598-024-73627-x

A systematic review on the techniques, long-term outcomes ... To evaluate the efficacy and safety of four techniques of partial breast irradiation (PBI) including interstitial brachytherapy (ISBT), ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9837822/

Pre-operative partial breast irradiation - PubMed Central - NIH Several early stage studies have more recently shown that PBI can be safely used in the pre-operative setting. Early data show similar local control without ...

7. redjournal.org redjournal.org/article/S0360-3016(22)03386-7/pdf

A Meta-Analysis of Trials of Partial Breast Irradiation It was hypothe- sized that this treatment would result in similar rates of local recurrence and breast cancer mortality with less acute and late radiation ...