Pre-Surgery Radiation for Early-Stage Breast Cancer

Overseen By Sohyun McElroy, Ph.D.

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University Comprehensive Cancer Center

Must be taking: Anti-endocrine therapy

Must not be taking: Radiation, Chemotherapy, Biotherapy

Disqualifiers: Hormone unresponsive, Stage III/IV, others

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

Compensation: Varies

Number of Visits: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method for treating early-stage breast cancer using a special type of radiation called Accelerated Partial Breast Irradiation (APBI) before surgery. The goal is to shrink the tumor and reduce the amount of normal tissue removed during surgery. It targets patients with stage I breast cancer sensitive to certain hormones (estrogen or progesterone). Candidates should have a single tumor that has not spread to lymph nodes and can tolerate lying face down for treatment. As an unphased trial, this study allows patients to contribute to innovative research that could enhance future treatment options.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, it does mention that you cannot have had any prior treatment with radiation, chemotherapy, biotherapy, or hormone therapy for the current breast cancer before joining the study.

What prior data suggests that this radiation therapy is safe for early-stage breast cancer patients?

Research has shown that image-guided intensity-modulated accelerated partial breast irradiation (APBI) is safe for patients with early-stage breast cancer. In one study, results after three years indicated minimal early and late side effects from the radiation, meaning patients experienced few severe problems post-treatment. Additionally, the breast's appearance post-treatment was rated as excellent to good.

Another study compared this radiation therapy to the traditional method of treating the whole breast. The findings suggested that APBI is a good option for early breast cancer because it targets only the tumor area, helping to protect surrounding healthy tissue.

Overall, these studies suggest that APBI is well-tolerated. Participants experienced fewer side effects and maintained a good quality of life after treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional whole-breast radiation therapy that typically spans several weeks, the treatment of accelerated partial breast irradiation (APBI) offers a quicker option. This method delivers focused radiation to the part of the breast where cancer is most likely to return, cutting down the treatment duration to just 5-10 days. Researchers are excited about image-guided intensity-modulated APBI because it allows for precise targeting of the tumor site, potentially reducing exposure to surrounding healthy tissue and minimizing side effects. This targeted approach not only enhances convenience but also holds promise for maintaining the quality of life for patients undergoing treatment for early-stage breast cancer.

What evidence suggests that intensity-modulated accelerated partial breast irradiation is effective for early-stage breast cancer?

This trial will evaluate image-guided intensity-modulated accelerated partial breast irradiation (APBI) for early-stage breast cancer. Studies have shown that APBI can lead to fewer side effects and better breast appearance over time, effectively targeting cancer while protecting healthy tissue. Research supports intensity-modulated radiation therapy (IMRT) as a modern method that enhances the precision of radiation targeting cancer cells. Both techniques aim to shrink tumors and preserve more healthy tissue. These methods offer promising options for treating early-stage breast cancer, particularly in older patients with hormone-sensitive tumors. ^{5 6 7 8 9}

Who Is on the Research Team?

Sasha Beyer, MD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for women over 50 with stage I breast cancer that's hormone responsive and hasn't spread. They must be able to have an MRI, lie prone during treatment, and agree to surgery after radiation. Excluded are those with large tumors (>3cm), prior breast treatments, or certain other cancers within the last 5 years.

Inclusion Criteria

You are able to undergo an MRI with a special dye called contrast.

A core biopsy shows breast cancer with positive estrogen or progesterone receptors.

Patients must be willing to undergo breast cancer surgery minimally 4, maximally 6 weeks post APBI.

Exclusion Criteria

Breast cancer that does not respond to hormone treatment.

You are planning to have a mastectomy.

You don't want to receive hormone therapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants undergo image-guided intensity-modulated accelerated partial breast irradiation (APBI) twice daily in the prone position

5-10 days

10 visits (in-person)

Surgery

Participants undergo lumpectomy within 4-6 weeks post-APBI

4-6 weeks post-radiation

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years

1 visit at 4 weeks, then every 6 months

What Are the Treatments Tested in This Trial?

Interventions

• Accelerated Partial Breast Irradiation
• Image-Guided Radiation Therapy
• Intensity-Modulated Radiation Therapy
• Therapeutic Conventional Surgery

Trial Overview

The study tests if giving a high-dose radiation therapy called intensity-modulated accelerated partial breast irradiation (APBI) before surgery can shrink tumors more effectively while sparing healthy tissue in older patients with early-stage hormone-positive breast cancer.

How Is the Trial Designed?

Group I: Treatment (image-guided intensity-modulated APBI) Experimental Treatment 4 Interventions

Patients undergo image-guided intensity-modulated APBI twice daily (BID) in the prone position over a period of 5-10 days for a total of 10 treatment. Within 4-6 weeks post-APBI, patients undergo lumpectomy.

Accelerated Partial Breast Irradiation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as APBI for:

• Early-stage breast cancer
• Ductal carcinoma in situ (DCIS)
• Stage I or II breast cancer

Approved in European Union as APBI for:

• Early-stage breast cancer
• Ductal carcinoma in situ (DCIS)
• Stage I or II breast cancer

Approved in Canada as APBI for:

• Early-stage breast cancer
• Ductal carcinoma in situ (DCIS)
• Stage I or II breast cancer

Who Is Running the Clinical Trial?

Ohio State University Comprehensive Cancer Center

Lead Sponsor

Trials

350

Recruited

295,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9685302/

Accelerated partial breast irradiation in early stage ...

The Florence trial showed statistically significant less acute and late toxicity and improved cosmetic outcomes with APBI at a median follow-up of 10 years (9).

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0360301624035144

Accelerated Partial Breast Irradiation for Early-Stage ...

These findings suggest that patients with early-stage ILC may be reasonably considered for APBI after lumpectomy.

3.

nature.com

nature.com/articles/s41598-025-85342-2

Quality of life in early breast cancer patients after adjuvant ...

Early BC patients treated with APBI showed non-inferior short-term and late HRQoL outcomes compared to hypo-WBI. In addition to previous ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6378667/

Effectiveness of different accelerated partial breast ...

This systematic review was conducted to compare the effectiveness of different accelerated partial breast irradiation (APBI) techniques for the treatment of ...

5.

breastsurgeons.org

breastsurgeons.org/docs/statements/Consensus-Statement-for-Accelerated-Partial-Breast-Irradiation.pdf

Resource Guide on Accelerated Partial Breast Irradiation

intensity-modulated radiation therapy (IMRT) in early-stage breast cancer, with a primary endpoint of determining 5-year difference31 in IBTR between 30 Gy ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/27872946/

Three-year results of a phase II clinical study

Three-year results are promising, early and late radiation side-effects are minimal, and cosmetic results are excellent to good. Keywords: APBI; Breast cancer; ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S0959804915000027

Accelerated partial breast irradiation using intensity ...

We present the results of a randomised trial comparing local recurrence and survival of APBI using the IMRT technique after BCS to conventional WBI in early ...

8.

practicalradonc.org

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

Partial Breast Irradiation for Patients With Early-Stage ...

This guideline provides evidence-based recommendations on appropriate indications and techniques for partial breast irradiation (PBI) for ...

9.

advancesradonc.org

advancesradonc.org/article/S2452-1094(25)00104-6/fulltext

Phase 2 Trial of Ultrahypofractionated Image-guided ...

Accelerated partial-breast irradiation compared with whole-breast irradiation for early breast cancer: long-term results of the randomized phase III APBI ...