What side effects are associated with this type of intervention?

Hypofractionated radiation therapy for breast cancer, which involves higher doses over a shorter period, can cause side effects such as skin irritation, fatigue, and localized pain. Long-term effects may include changes in skin texture and color, as well as potential damage to surrounding tissues. Common side effects of chemotherapy include nausea, vomiting, hair loss, fatigue, and increased risk of infection. Endocrine therapies, such as tamoxifen and aromatase inhibitors, can lead to hot flashes, joint pain, and an increased risk of bone density loss and cardiovascular issues.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer, including various forms of radiation therapy. Hypofractionated radiation therapy, which involves shorter, higher-dose radiation sessions over a shorter period, has been studied and shown to be effective. This approach is designed to be non-inferior to conventional fractionation, which is delivered over a longer period. While specific FDA approvals for hypofractionated radiation therapy in breast cancer are not detailed, this method aligns with the broader trend of optimizing radiation therapy to improve patient outcomes and convenience.

What other types of research exist?

Promising novel alternatives to hypofractionated radiation therapy for breast cancer patients include: 1) Accelerated Partial Breast Irradiation (APBI) using techniques like brachytherapy or 3D conformal radiotherapy, which target only the tumor bed and reduce treatment time. 2) Intensity-Modulated Radiation Therapy (IMRT) for precise targeting and sparing of healthy tissue. 3) Stereotactic Body Radiotherapy (SBRT) for delivering high doses of radiation to small, well-defined tumors. These methods aim to maintain or improve treatment efficacy while minimizing side effects and treatment duration.

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Hypofractionated Radiotherapy for Breast Cancer (RHEAL Trial)

Phase 3

Recruiting

Led By Timothy Whelan, MD

Research Sponsored by Ontario Clinical Oncology Group (OCOG)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No evidence of metastatic disease

Newly diagnosed invasive carcinoma of the breast treated with definitive surgery

Must not have

History of non-breast malignancy within the last 5 years other than non-melanoma skin cancer or treated in-situ carcinoma

Any prior history, not including index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 and 3 years post randomization

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial compares two radiation schedules for breast cancer patients to see if a shorter, higher-dose treatment is as effective as a longer, lower-dose one.

Who is the study for?

This trial is for adults with newly diagnosed node-positive breast cancer who've had surgery and need radiotherapy, but haven't spread to other body parts. It's not for those with recent non-breast cancers (except certain skin cancers), previous chest radiation, severe diseases like scleroderma or serious heart/lung conditions, under 18s, advanced tumor stages T4/N3, arm swelling after surgery, pregnant/breastfeeding women, or if they can't follow up for 5 years.

What is being tested?

The study compares two ways of giving radiotherapy: the standard method over 3 weeks versus a shorter one-week course. The goal is to see if the short course works just as well without making patients come in for treatment as often.

What are the potential side effects?

Radiotherapy may cause side effects such as skin irritation at the treatment site, fatigue during and after treatment sessions, potential development of lymphedema (swelling) in treated areas and rarely more serious issues involving heart or lung function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer has not spread to other parts of my body.

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I have recently been diagnosed with breast cancer and have undergone surgery.

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I am eligible for targeted radiation therapy after my surgery.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I haven't had cancer other than non-melanoma skin cancer or treated in-situ carcinoma in the last 5 years.

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I have had breast cancer or DCIS on the same side treated with radiation before.

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My cancer is at an advanced stage, affecting nearby tissues or lymph nodes.

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I am receiving hormone therapy before surgery.

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I have not had radiation on the same side breast or chest wall, nor do I have severe lung, heart disease, or scleroderma.

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I have had breast cancer in both breasts at the same time or in the past.

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I have swelling in the same side arm or chest as my cancer.

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I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 and 3 years post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 and 3 years post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 and 3 years post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Lymphedema

Secondary study objectives

Arm mobility

Breast cancer recurrence

Health Care Resource Utilization

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ExperimentalExperimental Treatment1 Intervention

Hypofractionation for locoregional radiotherapy

Group II: ControlActive Control1 Intervention

Conventional fractionation for locoregional radiotherapy

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Hypofractionated radiation therapy, a common treatment for breast cancer, involves delivering higher doses of radiation over a shorter period compared to conventional fractionation. This approach works by damaging the DNA of cancer cells, thereby inhibiting their ability to replicate and grow. The significance of hypofractionated radiation therapy for breast cancer patients lies in its convenience and potential for reduced treatment time, which can lead to improved patient compliance, reduced healthcare costs, and potentially fewer side effects. This method is particularly beneficial for older patients with early-stage, lower-grade tumors, as it offers an effective treatment option with a shorter duration.

Treatment Minimization in Older Patients With Early-Stage Breast Cancer.Abbreviated course of radiotherapy (RT) for breast cancer.