What is the mechanism of action of this treatment?

Pencil Beam Scanning Proton Radiotherapy is a form of targeted radiation therapy that uses protons to deliver high doses of radiation directly to the tumor while minimizing damage to surrounding healthy tissues. This precision is particularly important for breast cancer patients requiring regional nodal irradiation after mastectomy, as it reduces the risk of side effects and damage to critical structures such as the heart and lungs. Other common treatments for breast cancer include surgery (to remove the tumor), chemotherapy (to kill cancer cells throughout the body), hormone therapy (to block hormones that fuel certain types of breast cancer), and targeted therapy (to attack specific cancer cell mechanisms). The choice of treatment depends on the cancer's stage, type, and individual patient factors, aiming to maximize efficacy while minimizing adverse effects.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as radiation therapy, can lead to side effects including skin irritation, fatigue, and localized pain. Pencil Beam Scanning Proton Radiotherapy, a targeted form of radiation therapy, aims to minimize these side effects by precisely targeting the tumor and sparing surrounding healthy tissues. This precision reduces the risk of damage to nearby organs and tissues, potentially lowering the incidence of side effects like skin burns, heart and lung complications, and secondary cancers. However, patients may still experience fatigue and localized discomfort at the treatment site.

What prior FDA approvals exist?

The FDA has approved several targeted therapies for breast cancer that aim to minimize damage to surrounding tissues. One such treatment is proton beam therapy, which is recognized for its precision in targeting tumors while sparing healthy tissue. Additionally, the FDA has approved various PARP inhibitors like olaparib for patients with BRCA-mutated breast cancer, which target cancer cells more specifically than traditional chemotherapy. These treatments reflect a broader trend towards precision medicine in oncology, aiming to improve efficacy while reducing side effects.

What other types of research exist?

Promising novel alternatives to Pencil Beam Scanning Proton Radiotherapy for breast cancer patients include: 1) Carbon Ion Radiotherapy, which has shown similar efficacy to proton therapy in other cancers and may offer benefits in terms of precision and reduced side effects. 2) Stereotactic Body Radiotherapy (SBRT), which delivers high doses of radiation with precision, minimizing exposure to surrounding tissues. 3) Intensity-Modulated Radiation Therapy (IMRT), which allows for the modulation of radiation intensity to target tumors more precisely while sparing healthy tissue. These alternatives are being explored for their potential to provide effective treatment with minimal collateral damage.

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Proton Beam Therapy

Shorter Course Proton Therapy for Breast Cancer

Phase 2

Waitlist Available

Led By Robert W Mutter

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

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

Must have

ECOG Performance Status (PS) 0 to 2

pStage T1-T4N0-N3M0 or ypStage T0-4N0-N3M0. Note: The axilla must be staged by sentinel node biopsy alone, sentinel node biopsy followed by axillary node dissection, or axillary lymph node dissection alone

Must not have

Boosts to the chest wall after mastectomy. Nodal boosts are allowed

Medical contraindication to receipt of radiotherapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2 years, and 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is comparing different schedules of a precise radiation treatment for patients who have had breast removal surgery and need radiation to their lymph nodes. This treatment targets cancer cells precisely, reducing harm to healthy tissues. This method has been proposed to improve the long-term quality of life of breast cancer patients by reducing the dose to healthy tissue compared to traditional methods.

Who is the study for?

This trial is for adults over 18 with breast cancer who've had a mastectomy and need radiation to the lymph nodes. They should be in good enough health to consent, not pregnant, able to complete questionnaires, provide samples for research, and return for follow-up. Those with severe illnesses or conditions that could affect study results or safety are excluded.

What is being tested?

The trial tests two different schedules of proton radiotherapy after mastectomy: one using 15 treatments (fractions) and another using 25 fractions. It's randomized, meaning patients are put into groups by chance to compare the safety of these two approaches.

What are the potential side effects?

Potential side effects from proton radiotherapy can include skin reactions at the treatment site, fatigue, changes in skin coloration or texture, swelling due to fluid buildup (lymphedema), and less commonly heart or lung issues.

Eligibility Criteria

Inclusion Criteria

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

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I can take care of myself and am up and about more than half of my waking hours.

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My breast cancer is at a specific stage and my underarm lymph nodes were checked.

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I am 18 years old or older.

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I had breast cancer surgery and will receive radiation on my chest and nearby lymph nodes.

Exclusion Criteria

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

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I have received or will receive extra radiation to my chest wall after mastectomy.

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I cannot receive radiotherapy due to health reasons.

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I have active systemic lupus or scleroderma.

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I have been diagnosed with inflammatory breast cancer.

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I do not have any severe illnesses or social situations that would prevent me from following the study's requirements.

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I am pregnant or not using birth control while being able to conceive.

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I have had radiation on the same side as my current treatment but not on the opposite side.

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My breast cancer has come back after treatment.

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I haven't had any cancer other than breast cancer in the last 5 years.

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Cancer cells were found at the edge of the tissue removed during my last surgery.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2 years, and 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2 years, and 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2 years, and 5 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Complication Rate

Secondary study objectives

Cosmesis

Disease-free Survival (DFS)

Distant Recurrence Incidence

+7 more

Side effects data

From 2023 Phase 2 trial • 88 Patients • NCT02783690

91%

Dermatitis radiation

66%

Skin hyperpigmentation

34%

Joint range of motion decreased

30%

Non-cardiac chest pain

27%

Lymphedema

23%

Edema limbs

18%

Telangiestasia

18%

Esophagitis

16%

Breast infection

16%

Fibrosis deep connective tissue

16%

Superficial soft tissue fibrosis

Seroma

Brachial plexopathy

100%

80%

60%

40%

20%

Study treatment Arm

Hypofractionation

Conventional Fractionation

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: HypofractionationExperimental Treatment1 Intervention

40 Gy (RBE) in 15 daily fractions

Group II: Conventional FractionationActive Control1 Intervention

50.0 Gy (RBE) in 25 daily fractions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Hypofractionation

2017

Completed Phase 2

~550

0 / 14Eligibility 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

Pencil Beam Scanning Proton Radiotherapy is a form of targeted radiation therapy that uses protons to deliver high doses of radiation directly to the tumor while minimizing damage to surrounding healthy tissues. This precision is particularly important for breast cancer patients requiring regional nodal irradiation after mastectomy, as it reduces the risk of side effects and damage to critical structures such as the heart and lungs. Other common treatments for breast cancer include surgery (to remove the tumor), chemotherapy (to kill cancer cells throughout the body), hormone therapy (to block hormones that fuel certain types of breast cancer), and targeted therapy (to attack specific cancer cell mechanisms). The choice of treatment depends on the cancer's stage, type, and individual patient factors, aiming to maximize efficacy while minimizing adverse effects.