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

284 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to test whether a radiotherapy regimen of 8 GY x 3 days over 5 days (every other day) is as safe (well-tolerated) and effective as 6 Gy x 5 over five consecutive days

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 PBI Radiotherapy for Breast Cancer?

Research shows that partial breast irradiation (PBI) is effective for early-stage breast cancer, with studies reporting similar local recurrence rates to whole-breast irradiation. PBI can also improve quality of life by reducing treatment time and travel burdens. ^{1 2 3 4 5}

Is PBI Radiotherapy safe for breast cancer patients?

Research shows that PBI Radiotherapy is generally safe for breast cancer patients, with studies reporting mild long-term side effects and low immediate toxicity. Most patients experience minimal acute side effects, and the treatment is considered feasible and safe for selected early breast cancer cases. ^{1 5 6 7 8}

How does PBI Radiotherapy differ from other breast cancer treatments?

PBI Radiotherapy is unique because it targets only the tumor bed with high doses of radiation, unlike traditional whole-breast irradiation that treats the entire breast. This approach can reduce treatment time and potentially minimize side effects, making it a promising option for patients with early-stage breast cancer. ^{1 2 7 9 10}

Research Team

Naamit K Gerber, MD

Principal Investigator

NYU Langone Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

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

Seven fractions to deliver partial breast irradiation: the toxicity is Low. [2018]

2. Netherlands pubmed.ncbi.nlm.nih.gov

[Partial breast irradiation (PBI): the therapy of the future?]. [2010]

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

Five Fraction External Beam Partial Breast Irradiation: A User's Guide. [2023]

4. France pubmed.ncbi.nlm.nih.gov

[Partial irradiation of the breast: why, how?]. [2019]

5. Italy pubmed.ncbi.nlm.nih.gov

Hypofractionation of partial breast irradiation using radiobiological models. [2018]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Toxicity and cosmesis following partial breast irradiation consisting of 40 Gy in 10 daily fractions. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

First Experience in Korea of Stereotactic Partial Breast Irradiation for Low-Risk Early-Stage Breast Cancer. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Linac-Based Ultrahypofractionated Partial Breast Irradiation (APBI) in Low-Risk Breast Cancer: First Results of a Monoinstitutional Observational Analysis. [2023]

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

Outcome of a phase II prospective study on partial breast irradiation with interstitial multi-catheter high-dose-rate brachytherapy. [2013]

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

A Meta-Analysis of Trials of Partial Breast Irradiation. [2023]