Partial Breast Irradiation for Early Stage Breast Cancer

Not currently recruiting at 15 trial locations

Overseen By Benjamin D Smith

Age: 18+

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Bilateral breast cancer, Lupus, Scleroderma, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method of delivering radiation treatment for patients with early-stage breast cancer. It focuses on hypofractionated partial breast irradiation, which involves administering higher doses of radiation to a specific part of the breast over a shorter period. This approach may kill more cancer cells and cause fewer side effects than traditional methods. Individuals who have undergone breast-conserving surgery and have a small, hormone-sensitive breast tumor in one area might be suitable for this trial. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group, offering a chance to benefit from innovative care.

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?

In a previous study, researchers found that hypofractionated partial breast irradiation is a safe option for patients with early-stage breast cancer, resulting in fewer side effects compared to traditional methods. Another study confirmed that patients experienced fewer long-term side effects with this type of radiation, suggesting that the treatment is well-tolerated over time. Initial findings also indicate that targeting radiation only at the cancerous part of the breast may lead to fewer overall side effects.

These studies provide clear evidence that hypofractionated partial breast irradiation is a safe treatment option with potentially fewer negative effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about the partial breast irradiation techniques for early-stage breast cancer because they offer a more targeted approach compared to traditional whole breast irradiation. Arm I involves hypofractionated partial breast irradiation, which is delivered in just five days, significantly reducing treatment time. Arm II explores a more conventional schedule over 15 days but still focuses on just the affected part of the breast, potentially sparing healthy tissue from unnecessary radiation. These methods not only aim to be more convenient for patients but also hope to minimize side effects and improve overall quality of life during treatment.

What evidence suggests that hypofractionated partial breast irradiation is effective for early stage breast cancer?

This trial will compare two approaches to partial breast irradiation for early-stage breast cancer. Studies have shown that hypofractionated partial breast irradiation, which participants in Arm I will receive, can be effective. This method involves delivering higher doses of radiation over a shorter period, which research suggests can kill more cancer cells and may cause fewer side effects. Specifically, one study found that only 3.5% of patients experienced noticeable changes in breast appearance three years after treatment. Other studies confirm that this approach is safe and effective, offering better results and fewer long-term side effects compared to traditional whole-breast radiation. Participants in Arm II will receive standard breast irradiation, which requires a longer treatment duration. ^{1 4 6 7 8}

Who Is on the Research Team?

Benjamin D. Smith, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients with early stage breast cancer who've had breast conserving surgery, have estrogen receptor positive tumors, and no evidence of disease from prior non-breast cancers. It's not for those with nodal positivity beyond pN0(i+), history of radiation in the area, or previous invasive/in situ breast cancer.

Inclusion Criteria

My breast cancer has not spread to my lymph nodes.

My cancer is mainly in one spot, but small areas nearby may also have cancer.

My final surgery showed no cancer cells at the edges of the removed tissue.

Exclusion Criteria

I have had breast cancer before.

I have had radiation therapy in the chest area before.

I have a history of lupus or scleroderma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Patients undergo hypofractionated partial breast irradiation daily for 5 days or standard breast irradiation daily for 15 days, with optional boost fractions

1-3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

5.5 years

Visits at 6 months, 1.5, 3.5, and 5.5 years

What Are the Treatments Tested in This Trial?

Interventions

• Partial Breast Irradiation

Trial Overview The study tests hypofractionated partial breast irradiation to see if delivering higher doses over a shorter period is effective and results in fewer side effects than standard treatment. Only the part of the breast where cancer started is treated.

How Is the Trial Designed?

Group I: Arm I (hypofractionated partial breast irradiation) Experimental Treatment 3 Interventions

Patients undergo hypofractionated partial breast irradiation daily for 5 days. Patients may then receive 3 additional boost fractions at the discretion of the doctor.

Group II: Arm II (hypofractionated partial breast irradiation) Active Control 2 Interventions

Patients undergo standard breast irradiation daily for 15 days. Patients may then receive 5 additional boost fractions at the discretion of the doctor.

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

Approved in United States as Partial Breast Irradiation for:

• Early-stage invasive breast cancer
• Ductal carcinoma in situ (DCIS)

Approved in European Union as Partial Breast Irradiation for:

• Early-stage invasive breast cancer
• Ductal carcinoma in situ (DCIS)

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. nature.com nature.com/articles/s41598-025-88600-5

Hypofractionated partial breast irradiation after ... Our trial employed a PBI regimen of 40.05 Gy/15 fractions delivered by IMRT technique, and reported very low rates of cosmetic deterioration and ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38220538/

5Years Update of the HYPAB Trial Mature results confirm the safety and efficacy of APBI in selected early stage breast cancer patients. Late toxicity is improved in the APBI ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S096097762500476X

Long-term outcomes of three distinct once-daily schedules ... The efficacy of PBI compared to WBI for early-stage breast cancer has been demonstrated by the long-term results of three phase 3 trials: the UK IMPORT LOW ...

4. 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 ...

5. trial.medpath.com trial.medpath.com/news/cc15fdcc21a2090c/hypofractionated-partial-breast-irradiation-shows-promising-results-in-early-stage-breast-cancer-trial

Hypofractionated Partial Breast Irradiation Shows Favorable ... A study of 208 patients with early-stage breast cancer found a low 3.5% rate of cosmetic deterioration three years after hypofractionated partial breast ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12333179/

Phase II single vs hypofractionated irradiation for timely ... The 2017 IMPORT-LOW trial recruited 2018 early-stage breast cancer participants and split them between standard WBI with 40 Gy in 15 fractions, ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1526820923003282

Adjuvant Hypofractionated Whole Breast Irradiation (WBI) ... Mature results confirm the safety and efficacy of APBI in selected early stage breast cancer patients. Late toxicity is improved in the APBI arm at the cost of ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06677944

Preoperative Partial Breast Irradiation in Early-Stage ... Therefore, this study aims to compare and evaluate the overall clinical advantages, including safety and efficacy, of preoperative PBI and ...