High vs Standard Dose Radiation Therapy for Breast Cancer

Not currently recruiting at 587 trial locations

Age: 18+

Sex: Female

Trial Phase: Phase 3

Sponsor: Radiation Therapy Oncology Group

Must not be taking: Concurrent chemotherapy

Disqualifiers: Stage III/IV cancer, Bilateral cancer, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 1

Duration: 3 weeks for hypofractionated arm, 5-7 weeks for standard arm

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a higher daily dose of radiation therapy is as effective as the standard dose for treating early-stage breast cancer after surgery. Participants will receive either the higher dose with a concurrent boost or the standard dose with a sequential boost. Women who have undergone lumpectomy and meet specific criteria, such as having a certain type of tumor or previous treatment, may qualify as candidates. This research could enhance treatment for those with early-stage breast cancer. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, it does mention that concurrent chemotherapy for current breast cancer is not allowed, so you may need to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that using fewer, larger doses of radiation for breast cancer treatment is generally safe. In one study, over 70% of women who received this treatment had good or excellent cosmetic results after 10 years. Another study found this method to be as safe as traditional treatments, with some patients experiencing fewer side effects, such as skin irritation or tiredness.

Overall, evidence suggests that many patients tolerate this treatment well and find it effective. Patients often manage the treatment without serious issues while still benefiting from its ability to treat breast cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about high-dose radiation therapy for breast cancer because it offers a more intense treatment in a shorter period. Unlike standard radiation therapy, which involves a longer treatment duration, the hypofractionated approach delivers higher doses in fewer sessions, potentially leading to greater convenience for patients. Additionally, this method includes a concurrent boost, possibly enhancing its effectiveness by targeting the tumor with more precision. Overall, this innovative approach could improve treatment outcomes and reduce the burden of prolonged therapy for patients.

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

Research has shown that hypofractionated whole breast irradiation (H-WBI), a treatment option in this trial, works well for early-stage breast cancer. In one study, 69.8% of women who received H-WBI reported good or excellent cosmetic results after ten years, similar to those who underwent the standard treatment. Another study found that administering 26 Gy of radiation over five sessions was as effective and safe as the usual 15-session treatment. These studies suggest that H-WBI can effectively treat breast cancer and may offer a shorter treatment duration. Meanwhile, standard fractionation whole breast irradiation (WBI) with sequential boost, another treatment option in this trial, remains a widely used approach. ^{3 6 7 8 9}

Who Is on the Research Team?

Frank A. Vicini, MD, FACR

Principal Investigator

St. Joseph Mercy Oakland

Gary M. Freedman, MD

Principal Investigator

University of Pennsylvania

Douglas W. Arthur, MD

Principal Investigator

Virginia Commonwealth University

Julia R. White, MD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for women over 18 who've had early-stage breast cancer surgically removed within the last 50 days. They must not be pregnant, agree to use contraception during treatment, and have no history of certain cancers or severe illnesses. Breast implants are okay, but prior radiation therapy in the same area or plans for chemotherapy alongside this treatment disqualify them.

Inclusion Criteria

Patient must provide study specific informed consent prior to study entry

I had surgery to remove breast cancer and radiation on the whole breast without treating the lymph nodes.

For invasive breast cancer, the armpit area must be examined using one of the following methods:

Exclusion Criteria

I have been cancer-free for at least 5 years, except for non-melanoma skin cancer or cervical carcinoma in situ.

My treatment plan includes radiation therapy to the lymph nodes.

I plan to receive chemotherapy alongside other treatments for my breast cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either accelerated hypofractionated whole-breast irradiation with a concomitant boost or standard whole-breast irradiation with a sequential boost

3 weeks for hypofractionated arm, 5-7 weeks for standard arm

Evaluated weekly during radiation therapy

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

1 month, 6 months, 12 months, then annually

What Are the Treatments Tested in This Trial?

Interventions

• Higher per daily radiation therapy
• Standard per daily radiation therapy

Trial Overview The study compares two types of radiation therapy after breast surgery: a higher dose given less frequently with a concurrent boost versus the standard daily dose with a sequential boost. It's randomized, meaning patients are put into groups by chance to see which method works best.

How Is the Trial Designed?

Group I: Hypofractionated whole breast irradiation + concurrent boost Experimental Treatment 2 Interventions

Hypofractionated whole breast (H-WBI) irradiation with a concurrent boost

Group II: Whole breast irradiation + sequential boost Active Control 2 Interventions

Standard fractionation whole breast irradiation (WBI) with sequential boost.

Who Is Running the Clinical Trial?

Radiation Therapy Oncology Group

Lead Sponsor

Trials

191

Recruited

64,900+

NRG Oncology

Collaborator

Trials

242

Recruited

105,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8934112/

Has Hypofractionated Whole Breast Radiation Therapy ... After the guidelines were published, an analysis of National Cancer Database (NCDB) data reported that the usage of HF-WBI reached 15.6% among invasive cancer ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa0906260

Long-Term Results of Hypofractionated Radiation Therapy ... At 10 years, 71.3% of women in the control group as compared with 69.8% of the women in the hypofractionated-radiation group had a good or excellent cosmetic ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0960977625006526

Once-Weekly Ultra-Hypofractionated Radiation Therapy for ... This study reports outcomes of once-weekly adjuvant whole-breast radiotherapy in elderly and/or comorbid patients with breast cancer, ...

4. practicalradonc.org practicalradonc.org/article/S1879-8500(22)00203-X/abstract

Clinical Outcomes of Hypofractionated Whole Breast ... Our data support the use of moderate HWBI in patients with early-stage, biologically high-risk breast cancer. Practical Radiation Oncology home.

5. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(20)30932-6/fulltext

Hypofractionated breast radiotherapy for 1 week versus 3 ... FAST-Forward results confirm that 26 Gy in five fractions is as effective and safe as an international standard 15-fraction regimen after ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6286164/

Results of a Randomized, Noninferiority Clinical Trial - PMC Three-year outcomes with hypofractionated versus conventionally fractionated whole-breast irradiation: results of a randomized, noninferiority clinical trial.

7. sciencedirect.com sciencedirect.com/science/article/pii/S0360301624007727

103 Early Safety of Ultra-Hypofractionated Whole Breast ... The Phase 3 FAST-Forward trial showed that 26 Gy in 5 fractions over 1 week for whole breast irradiation (WBI) was safe and efficacy for ...

8. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-024-11918-2

Efficacy and safety analysis of hypofractionated ... - BMC Cancer In this meta-analysis, we conducted a comparative analysis of the safety and efficacy of hypofractionated and conventional fractionated ...

9. e-roj.org e-roj.org/journal/view.php?number=1280

Hypofractionated whole breast irradiation: new standard in ... Hypofractionated whole breast irradiation (HF-WBI) has been proved effective and safe and even better for late or acute radiation toxicity for early breast ...