Shorter Radiation Therapy for Breast Cancer

Overseen By Benjamin Smith, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Scleroderma, Psychiatric illness, 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: Unknown

768 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if shorter radiation therapy effectively benefits breast cancer patients who have undergone surgery and are at risk of recurrence. It examines two types of radiation treatments: moderately hypofractionated (fewer sessions with a slightly higher dose each time) and ultrahypofractionated (even fewer sessions with higher doses). The trial organizes participants into groups based on the type of surgery and the risk level of cancer recurrence. Suitable candidates for this trial include those who have had a lumpectomy or mastectomy, have been advised to undergo regional nodal irradiation, and are within 12 weeks of surgery or chemotherapy. As a Phase 2 trial, it measures the treatment's effectiveness in an initial, smaller group, allowing participants to contribute to significant research.

Do I need to stop my current medications to join the trial?

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?

Research has shown that both moderately hypofractionated and ultrahypofractionated radiation therapies are safe options for treating breast cancer.

For moderately hypofractionated radiation, studies involving nearly 8,000 patients have indicated it is as safe as traditional radiation treatments. This method is efficient, convenient, and safe for various breast cancer cases and treatment methods.

Ultrahypofractionated radiation has also demonstrated promising safety results. In one study, more than half of the patients experienced no skin issues, and most reported either no side effects or only mild ones.

These findings suggest that both radiation methods are generally well-tolerated, making them good options for patients considering clinical trials for breast cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these radiation therapy approaches for breast cancer because they offer a potentially quicker and more convenient treatment regimen. Unlike traditional radiation treatments that can take several weeks, these methods—moderately hypofractionated and ultrahypofractionated radiation—shorten the overall treatment time. The ultrahypofractionated radiation is particularly intriguing as it delivers higher doses in fewer sessions, potentially reducing the burden on patients while maintaining effectiveness. By exploring these faster options, researchers hope to improve patients' quality of life and make it easier to complete their cancer treatment.

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

This trial will compare moderately hypofractionated radiation and ultrahypofractionated radiation for breast cancer. Studies have shown that moderately hypofractionated radiation, which participants in this trial may receive, is as effective and safe as traditional radiation treatments for breast cancer. Research indicates that it works well for both early-stage cancers and those at higher risk of recurrence. Ultrahypofractionated radiation, another treatment option in this trial, has been proven to reduce the chance of cancer returning by 16% over 10 years. It also effectively targets the cancer area with minimal side effects. Both treatments offer promising outcomes and are supported by strong evidence for their effectiveness in treating breast cancer. ^{4 5 6 7 8}

Who Is on the Research Team?

Benjamin Smith, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for men and women with node-positive or high-risk node-negative invasive breast cancer who have undergone a lumpectomy or mastectomy. It's designed to see if shorter radiation therapy schedules are effective in preventing the cancer from returning.

Inclusion Criteria

Ability to understand and the willingness to sign a written informed consent document

Concurrent enrollment on other observational, translational, or therapeutic studies is allowed provided there is no direct conflict between the other protocol and the radiation regimen proscribed in this trial

My oncologist recommends radiation therapy for my lymph nodes.

Exclusion Criteria

Pregnant women

I've had radiation therapy in the same area that needs treatment now.

I have a history of scleroderma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Treatment

Participants receive moderately hypofractionated or ultrahypofractionated radiation therapy with regional nodal irradiation (RNI) based on cohort assignment

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including the occurrence of any grade 2 or higher NCI CTCAE toxicity

18 months

What Are the Treatments Tested in This Trial?

Interventions

• Moderately hypofractionated radiation
• Ultrahypofractionated radiation

Trial Overview The study is testing two types of shortened radiation therapy after surgery: moderately hypofractionated radiation and ultrahypofractionated radiation. Participants will be randomly assigned to one of these treatments to compare their effectiveness.

How Is the Trial Designed?

Group I: Low-Risk Mastectomy Cohort Arm 2: Moderately Hypofractionated Breast+RNI Experimental Treatment 1 Intervention

Group II: Low-Risk Mastectomy Cohort Arm 1: Ultrahypofractionated Chest Wall+RNI Experimental Treatment 1 Intervention

Group III: Low-Risk Lumpectomy Cohort Arm 2: Moderately Hypofractionated Breast+RNI with SIB Experimental Treatment 1 Intervention

Group IV: Low-Risk Lumpectomy Cohort Arm 1: Ultrahypofractionated Breast+RNI with SIB Experimental Treatment 1 Intervention

Group V: High-Risk Mastectomy Cohort Arm 2: Moderately Hypofractionated Chest Wall+RNI with Sequential Boost Experimental Treatment 1 Intervention

Group VI: High-Risk Mastectomy Cohort Arm 1: Moderately Hypofractionated Chest Wall+RNI with SIB Experimental Treatment 1 Intervention

Group VII: High-Risk Lumpectomy Cohort Arm 2: Moderately Hypofractionated Breast+RNI with Sequential Boost Experimental Treatment 1 Intervention

Group VIII: High-Risk Lumpectomy Cohort Arm 1: Moderately Hypofractionated Breast+RNI with SIB Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. redjournal.org redjournal.org/article/S0360-3016(23)08024-0/fulltext

Physician- and Patient-Reported Outcomes of the MC1635 ... Our aim was to report physician- and patient-reported outcomes of patients with localized breast cancer treated with moderate versus ultrahypofractionated ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9073333/

Systematic review and meta-analysis of randomized clinical ... Moderately hypofractionated is at least as effective and safe as conventional radiation irradiation regimens and should be considered as a treatment option.

3. sciencedirect.com sciencedirect.com/science/article/pii/S1879850025000669

Six-Year Results From a Prospective Phase 2 Trial of 10 ... We report the 6-year results of a phase 2 study on hypofractionated radiation therapy targeting the primary and regional lymph nodes in 10 fractions.

4. thelancet.com thelancet.com/journals/lanam/article/PIIS2667-193X(22)00140-5/fulltext

Moderately hypofractionated radiation therapy for breast ... This study aims to describe the profile and clinical outcomes of patients treated with moderate hypofractionation for both early-stage (Stage I and II) and ...

5. thegreenjournal.com thegreenjournal.com/article/S0167-8140(25)00144-6/abstract

First results of the UNICANCER HypoG-01 phase III trial First HypoG-01 phase III trial early safety report. · HypoG-01: 40 Gy in 15 fr Vs 50 Gy in 25Fr for nodal irradiation in early breast cancer. · HypoG-01 shows low ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10547413/

Moderately hypofractionated post-operative radiation ... Primarily, these studies with almost 8000 patients have demonstrated that hypofractionation is as safe and effective as conventional fractionation. Nevertheless ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1040842820302262

Review The use of moderately hypofractionated post- ... Moderately hypofractionated RT for breast cancer is efficient, convenient and safe for all indications, target volumes and techniques.

8. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2822041

Hypofractionated vs Conventionally Fractionated ... This study's finding that hypofractionation did not result in significantly improved physical well-being at 6 months adds to the growing body of data.