Radiotherapy for Early-Stage Breast Cancer

(H-ASSIST Trial)

Overseen By Cory Grreenwood

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: UNC Lineberger Comprehensive Cancer Center

Disqualifiers: Autoimmune conditions, Collagen Vascular Disease, 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

Compensation: Varies

Number of Visits: 17

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a shorter, 5-session radiation therapy for early-stage breast cancer to determine if it matches the benefits of longer treatments. It uses a technique called simultaneous integrated boost (SIB), which delivers an extra dose to the tumor area alongside regular radiation. The trial aims to assess side effects, quality of life, and cancer outcomes. Women who have undergone breast-conserving surgery and do not require complex radiation may be suitable candidates for this study. As a Phase 2 trial, the research measures the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to discuss your specific medications with the trial team to ensure they won't interfere with the study.

What prior data suggests that this radiotherapy technique is safe for early-stage breast cancer?

Research has shown that a new type of breast cancer radiation treatment is safe for early-stage patients. This treatment uses fewer but slightly stronger doses of radiation and is well-tolerated, with no additional early side effects. The FAST-Forward trial found that five treatment sessions work as well as the traditional three-week course, providing the same level of tumor control. Patients can thus have fewer sessions without losing effectiveness. Overall, these findings suggest the treatment is safe, with manageable side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy with Simultaneous Integrated Boost (WBI-SIB) because it offers a potentially more efficient and convenient treatment for early-stage breast cancer. Unlike traditional radiation therapy, which typically involves multiple sessions over several weeks, this approach delivers the entire treatment in just five sessions. The simultaneous integrated boost targets the tumor bed more precisely while sparing surrounding healthy tissue, which could lead to fewer side effects and improved quality of life for patients. By significantly reducing the treatment time, WBI-SIB may make radiation therapy more accessible and less burdensome for patients.

What evidence suggests that this radiotherapy technique is effective for early-stage breast cancer?

Studies have shown that very short radiation therapy, known as ultra hypofractionated therapy, can be as effective as longer treatments for early-stage breast cancer. The FAST-Forward trial found that a 1-week radiation course worked as well as the traditional 3-week course in preventing cancer recurrence. In this trial, participants will receive a similar 5-session plan with an extra dose to the tumor area, called the simultaneous integrated boost (SIB), which might further reduce the chance of cancer returning. Research indicates that adding this extra dose during radiation can lower the risk of recurrence. Overall, this shorter, more intense treatment seems promising for those seeking to reduce hospital visits while still effectively treating their cancer. ^{1 2 5 6 7}

Who Is on the Research Team?

Dana Casey, MD

Principal Investigator

UNC Lineberger Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for individuals with early-stage breast cancer or ductal carcinoma in situ who have undergone surgery. It's designed to test a short, 5-session radiation therapy that includes a simultaneous boost to the tumor bed, aiming to reduce treatment time and recurrence risk.

Inclusion Criteria

Willing and able to provide written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information

Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial, per the discretion of the treating radiation oncologist

Enrollment in another clinical trial is allowed if there is no interference with interventions on this trial per discretion of the Principal Investigator

Exclusion Criteria

Autoimmune conditions

I have cancer in both breasts needing radiation on both sides.

My cancer has spread to distant parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive 5-fraction whole breast irradiation with a simultaneous integrated boost

1 week

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Regular visits for assessments at 12 and 24 months

What Are the Treatments Tested in This Trial?

Interventions

• Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost

Trial Overview The study is testing a condensed whole breast irradiation (WBI) schedule over five sessions with an integrated boost directly to the tumor area. This approach follows evidence suggesting shorter radiation courses can be as effective as longer ones.

How Is the Trial Designed?

Group I: WBI-SIB Experimental Treatment 1 Intervention

Five-fraction whole breast irradiation (WBI) with simultaneous integrated tumor bed boost (SIB).

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

Published Research Related to This Trial

In a study of 200 breast cancer patients, those receiving accelerated radiotherapy in 5 fractions experienced significantly lower acute toxicity compared to those receiving treatment in 15 fractions, with notable reductions in breast pain, fatigue, edema, and dermatitis.

Patients treated with the 5-fraction schedule reported better health-related quality of life, including improved physical well-being and less deterioration in social functioning, indicating that this treatment approach may enhance patient comfort and overall experience during therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute toxicity and health-related quality of life after accelerated whole breast irradiation in 5 fractions with simultaneous integrated boost. Van Hulle, H., Vakaet, V., Monten, C., et al.[2022]

In a study of 27 early breast cancer patients, hypofractionated whole-breast irradiation with a daily boost showed low skin toxicity, with 92.6% of patients experiencing no skin toxicity after 18 months.

The treatment resulted in excellent cosmetic outcomes, with minimal breast edema and skin changes, suggesting it is a feasible alternative to traditional longer radiation schedules, although longer follow-up is needed to confirm local control rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated hypofractionated whole-breast irradiation with concomitant daily boost in early breast cancer. Kyrgias, G., Zygogianni, A., Theodorou, K., et al.[2022]

In a study of 27 breast cancer patients, accelerated hypofractionated radiotherapy with simultaneous integrated boost (SIB) showed acceptable rates of acute skin toxicity, with only 33% experiencing grade 1 and 18.5% experiencing grade 2 toxicities, indicating a relatively safe treatment option.

The treatment resulted in good disease-free survival (DFS) and overall survival (OS) rates of 88% and 92% at four years, respectively, with excellent or good cosmetic outcomes in 100% of patients, demonstrating both efficacy and favorable long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Accelerated hypofractionated breast radiotherapy with simultaneous integrated boost: a feasibility study. Yadav, BS., Gupta, S., Dahiya, D., et al.[2022]

Hypofractionated radiation therapy is an effective treatment option for selected early breast cancer patients after breast-conserving surgery, allowing for higher doses in fewer sessions.

The optimal timing, fractionation, and total dose for delivering the tumor bed boost in hypofractionated schedules are still being researched, indicating a need for further studies to refine treatment protocols.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tumor Bed Boost Integration during Whole Breast Radiotherapy: A Review of the Current Evidence. Franco, P., Cante, D., Sciacero, P., et al.[2020]

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. advancesradonc.org advancesradonc.org/article/S2452-1094(24)00231-8/fulltext

Ultrahypofractionated Adjuvant Breast Radiation Therapy ... In this trial, 25% of the patients received a sequential boost, which was conventionally fractionated. Further data regarding the late toxicity ...

3. redjournal.org redjournal.org/article/S0360-3016(25)00348-7/fulltext

NOVEMBER, A Phase 2 Trial of a 9-Day Course of Whole ... Adjuvant radiation therapy (RT) plays an important role in the treatment of early-stage breast cancer as RT has been shown to significantly ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2452109424002318

Ultrahypofractionated Adjuvant Breast Radiation Therapy ... Ultrahypofractionated breast radiation therapy leads to acceptable late toxicity at 1 year, even when followed by a hypofractionated tumor bed boost.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11999331/

Tolerance of Adjuvant Ultrahypofractionated Whole-Breast ... Our findings indicate that uhWBRT, with or without a moderately hypofractionated boost, is safe and well tolerated.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40992655/

Ultra-Hypofractionated Whole Breast Radiation Therapy ... Purpose: The 5-year results of the FAST-Forward trial demonstrate non-inferiority of local tumor control using a 26 Gy in 5 fraction regimen ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301625001415

Ultrahypofractionation and Simultaneous Integrated Boost ... UHF with SIB of 29 Gy to the tumor bed in patients with early-stage breast cancer is clinically feasible, safe, and free of an excess of early side effects.