Radiation Therapy for Inoperable Breast Cancer

(DEFINE Trial)

Overseen By Caterina Stony Brook Cancer Center Clinical Trials

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Alexander Stessin

Must be taking: Endocrine therapy, HER2-targeted therapy, immunotherapy

Must not be taking: Systemic therapy

Disqualifiers: Prior radiation, body habitus, others

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

Compensation: Varies

Number of Visits: Unknown

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding radiation therapy to standard breast cancer medications can slow or stop the progression of the disease. It targets individuals with advanced breast cancer that is inoperable or for those who opt out of surgery. Participants will receive whole breast radiation with simultaneous integrated boost (WB-SIB), focusing on the main tumor and, in some cases, nearby lymph nodes. Those with inoperable cancer or who have declined surgery may find this trial suitable.

As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could lead to new treatment options for advanced breast cancer.

Will I have to stop taking my current medications?

The trial allows you to continue taking certain medications like endocrine therapy, HER2-targeted therapy, or immunotherapy. However, other systemic therapies are not allowed during the trial.

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

Research shows that whole breast radiation with a simultaneous integrated boost (WB-SIB) is generally manageable for patients. Studies have found that this method can cause less skin irritation compared to other techniques, resulting in fewer side effects like redness or soreness.

For those receiving WB-SIB to both the main breast tumor and nearby lymph nodes, the safety remains consistent. This method also shortens the overall treatment time, which many patients find beneficial.

Overall, previous research considers the treatment safe, with side effects that most patients can manage. It is always important to discuss with a healthcare provider to understand how this treatment might affect an individual personally. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using whole breast radiation with a simultaneous integrated boost (WB-SIB) because it targets the primary breast tumor more precisely. Unlike standard radiation therapy options, which often treat the entire breast uniformly, WB-SIB delivers a higher dose of radiation directly to the tumor and, in some cases, the nearby lymph nodes, potentially sparing healthy tissue and reducing side effects. This targeted approach could improve outcomes for patients with both node-negative and node-positive inoperable breast cancer by offering a more focused and aggressive treatment option.

What evidence suggests that this trial's radiation therapy treatments could be effective for inoperable breast cancer?

This trial will compare two approaches using whole breast radiation with a simultaneous integrated boost (SIB) for treating inoperable breast cancer. Studies have shown that SIB effectively treats breast cancer, resulting in high rates of local control and improved survival. For instance, one study reported a 93% survival rate and a 92% local control rate over three years. In this trial, one group will receive SIB targeting only the primary breast tumor, while another group will receive SIB targeting both the primary breast tumor and the ipsilateral axillary lymph nodes. For patients whose cancer has spread to the lymph nodes, adding SIB to treat these areas appears promising, although researchers continue to gather more data on its effectiveness. Overall, these treatments show strong potential for effectively managing breast cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Alexander Stessin, MD PhD

Principal Investigator

Stony Brook University Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with locally advanced breast cancer who are unable to undergo surgery or choose not to. They can still consider surgery later on. Specific eligibility details are not provided, but typically participants must meet certain health standards and agree to follow the study procedures.

Inclusion Criteria

My breast cancer is at a stage where it may have spread locally or to nearby lymph nodes but not widely.

My breast cancer diagnosis was confirmed by a biopsy.

My cancer cannot be removed by surgery, or I am not fit for surgery, or I chose not to have surgery.

Exclusion Criteria

I am not on any systemic therapy except for endocrine, HER2, or immunotherapy.

I have had radiation therapy on the same side breast or nearby lymph nodes.

My body shape or size prevents me from receiving the study treatment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive ultra-hypofractionated whole breast radiation therapy with simultaneous integrated boost to the gross tumor

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of acute and late toxicity

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor
• Whole breast radiation with simultaneous integrated boost (WB-SIB) to primary breast tumor and ipsilateral axillary lymph nodes

Trial Overview

The study is testing if adding radiation therapy to standard breast cancer medications improves outcomes. There are two types of radiation being compared: one targeting just the primary breast tumor, and another also including nearby lymph nodes.

How Is the Trial Designed?

Group I: B: Ipsilateral axillary node-positive breast cancer Experimental Treatment 1 Intervention

Patients with ipsilateral axillary node-positive disease, regardless of metastatic status (Stages T1-4 N1-2 M0-1)

Group II: A: Ipsilateral axillary node-negative breast cancer Experimental Treatment 1 Intervention

Patients with ipsilateral axillary lymph node-negative disease, regardless of metastatic status (Stages T1-4 N0 M0-1)

Who Is Running the Clinical Trial?

Alexander Stessin

Lead Sponsor

Northwell Health

Collaborator

Trials

481

Recruited

470,000+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06902311

Ultra Hypo-fractionated Adjuvant Whole Breast Radiation ...

This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12134538/

Comparison of simultaneous integrated tumor bed boost and ...

This study aimed to compare the safety and efficacy of simultaneous integrated boost (SIB) and sequential boost (SeB) during ...

3.

sciencedirect.com

sciencedirect.com/science/article/pii/S1526820914002031

Modified Simultaneous Integrated Boost Radiotherapy for ...

The purpose of this study was to evaluate the effect of modified simultaneous integrated boost (SIB) radiotherapy for patients with extensive breast cancer.

4.

link.springer.com

link.springer.com/article/10.1007/s00066-025-02445-5

Locally advanced breast cancer: primary ultra- ...

They were treated by irradiation to the breast with 25 Gy in five fractions with a simultaneous integrated boost (SIB) of 6 Gy per fraction.

5.

journals.sagepub.com

journals.sagepub.com/doi/10.1177/1533033818799355

Definitive Radiotherapy With SBRT or IMRT Boost for ...

Overall survival, progression-free survival, and local control rates were 93%, 85%, and 92%, respectively, at 3 years. In 50% of the patients, ...

6.

nature.com

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

Five-year survival outcomes of intensity-modulated ...

Intensity-modulated radiotherapy with simultaneous integrated boost (IMRT-SIB) reduces overall treatment duration and results in less radiotherapy (RT)-induced ...

7.

ro-journal.biomedcentral.com

ro-journal.biomedcentral.com/articles/10.1186/s13014-025-02584-0

Sequential or simultaneous-integrated boost in early-stage ...

Simultaneous-integrated boost for early-stage breast cancer can reduce skin toxicity compared to sequential techniques but with the risk of compromising tumor ...