90 Participants Needed

Radiotherapy for Early-Stage Breast Cancer

(H-ASSIST Trial)

JB
CG
Overseen ByCory Grreenwood
Age: 18+
Sex: Female
Trial Phase: Phase 2
Sponsor: UNC Lineberger Comprehensive Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study evaluates the rates of radiation-specific toxicity, quality of life, and oncologic outcomes for early-stage breast cancer and ductal carcinoma in situ treated with 5-fraction whole breast irradiation (WBI) with a simultaneous integrated tumor bed boost (SIB). SIB refers to the technique tumor bed boost given at the same time as standard radiation therapy.The FAST-Forward trial previously showed that a 1-week course of radiotherapy had similar effects to the traditional 3-week course for early-stage breast cancer after surgery. Given these favorable results, a 5-fraction WBI regimen is appealing for many patients who wish to minimize the number of treatment visits while still reducing their risk of recurrence. Generally, tumor bed boosts further decrease the risk of recurrence, but in the setting of 5-fraction WBI, a more traditional sequential boost technique is utilized.

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.

Is the radiotherapy treatment for early-stage breast cancer safe?

Research shows that this type of radiotherapy, which involves giving higher doses over a shorter period, is generally safe for early-stage breast cancer patients. Studies have looked at the side effects and found them to be manageable, with some patients experiencing mild to moderate side effects.12345

How is the radiotherapy treatment for early-stage breast cancer different from other treatments?

This treatment uses an accelerated schedule of radiotherapy, delivering the therapy in fewer sessions with a daily boost, which can reduce the overall treatment time and potentially lessen the burden on patients compared to traditional schedules.12567

What data supports the effectiveness of the treatment Ultra Hypo-fractionated Adjuvant Whole Breast Radiation Therapy With Simultaneous Integrated Boost for early-stage breast cancer?

Research shows that using a higher dose of radiation over fewer sessions (hypofractionation) is effective for some early breast cancer patients, and adding a boost (extra dose) to the tumor area during whole breast radiation is feasible and generally well-tolerated.278910

Who Is on the Research Team?

DC

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
See 3 more

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.
See 5 more

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?
1Treatment groups
Experimental Treatment
Group I: WBI-SIBExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials
377
Recruited
95,900+

Published Research Related to This Trial

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.
Tumor Bed Boost Integration during Whole Breast Radiotherapy: A Review of the Current Evidence.Franco, P., Cante, D., Sciacero, P., et al.[2020]
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.
Accelerated hypofractionated breast radiotherapy with simultaneous integrated boost: a feasibility study.Yadav, BS., Gupta, S., Dahiya, D., 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.
Accelerated hypofractionated whole-breast irradiation with concomitant daily boost in early breast cancer.Kyrgias, G., Zygogianni, A., Theodorou, K., et al.[2022]

Citations

Hypofractionated boost after whole breast irradiation in breast carcinoma: chronic toxicity results and cosmesis. [2022]
Tumor Bed Boost Integration during Whole Breast Radiotherapy: A Review of the Current Evidence. [2020]
An accelerated hypofractionated schedule with a daily concomitant boost after breast conservation surgery: the feasibility and toxicity. [2022]
Intensity modulated radiation therapy with simultaneous integrated boost in early breast cancer irradiation. Report of feasibility and preliminary toxicity. [2022]
Accelerated hypofractionated breast radiotherapy with simultaneous integrated boost: a feasibility study. [2022]
Accelerated hypofractionated whole-breast irradiation with concomitant daily boost in early breast cancer. [2022]
Evidence based whole breast hypo-fractionated radiation therapy in patients with early breast cancer. [2018]
Weekly concomitant boost in adjuvant radiotherapy for patients with early breast cancer: preliminary results on feasibility. [2022]
Acute toxicity and health-related quality of life after accelerated whole breast irradiation in 5 fractions with simultaneous integrated boost. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
Long-term results of hypofractionation with concomitant boost in patients with early breast cancer: A prospective study. [2021]
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