146 Participants Needed

Proton Beam vs X-ray Radiation Therapy for Breast Cancer

Recruiting at 2 trial locations
CT
Overseen ByClinical Trials Referral Office
Age: 18+
Sex: Female
Trial Phase: Phase 3
Sponsor: Mayo Clinic
No Placebo GroupAll 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 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 phase III trial compares the rate of complications of x-ray therapy versus proton beam radiation therapy after breast conserving surgery or mastectomy in treating patients with breast cancer. X-ray therapy is a form of radiation therapy that uses high-energy radiation from x-rays to kill tumor cells and shrink tumors. Proton beam radiation therapy is a type of radiation therapy that uses high-energy beams to treat tumors. It is not yet known what level of complications x-ray therapy or proton beam radiation therapy have in treating patients with breast cancer.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to consult with the principal investigator or your doctor for guidance.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial's principal investigator or your doctor.

What safety data exists for proton vs. X-ray radiation therapy in breast cancer?

Proton beam therapy (PBT) for breast cancer shows comparable or improved skin toxicity rates compared to photon therapy, with grade 1 dermatitis at about 25% and grade 2 dermatitis at 71-75%. Esophagitis rates are similar to photon therapy, and PBT may reduce cardiac risks by keeping the mean heart dose at ≤ 1 Gy. Radiation pneumonitis and rib fractures are rare. A randomized trial is underway to provide more robust conclusions.12345

Is proton beam therapy safe for treating breast cancer?

Proton beam therapy for breast cancer shows similar or better skin safety compared to traditional X-ray therapy, with rare cases of lung inflammation and rib fractures. It also minimizes heart exposure, potentially reducing heart-related risks.12345

Is Proton Beam Radiation Therapy a promising treatment for breast cancer?

Yes, Proton Beam Radiation Therapy is promising for breast cancer because it can target the cancer more precisely, reducing radiation to healthy tissues like the heart and lungs. This may lead to fewer side effects and better outcomes for patients.56789

How is proton beam therapy different from X-ray therapy for breast cancer?

Proton beam therapy is unique because it delivers radiation in a more targeted way, reducing exposure to nearby organs like the heart and lungs, which may lower the risk of side effects compared to traditional X-ray therapy.56789

What data supports the idea that Proton Beam vs X-ray Radiation Therapy for Breast Cancer is an effective treatment?

The available research shows that Proton Beam Therapy can be more effective than X-ray Radiation Therapy for breast cancer by reducing the amount of radiation that accidentally reaches the heart. This can lead to fewer heart-related health issues after treatment. Additionally, Proton Therapy may better protect other organs and reduce side effects compared to X-ray Therapy. However, more evidence is needed to confirm these benefits, as the number of patients treated with Proton Therapy is still relatively small.37101112

What data supports the effectiveness of the treatment Proton Beam Radiation Therapy for breast cancer?

Research suggests that proton therapy, a type of radiation treatment, may reduce the risk of heart-related side effects compared to traditional photon therapy by limiting radiation exposure to the heart during breast cancer treatment.37101112

Who Is on the Research Team?

Carlos E. Vargas, M.D. - Doctors and ...

Carlos E. Vargas, M.D.

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for adults over 18 with breast cancer who've had surgery to remove it. They should be in fair health (ECOG PS 0-2) and able to consent. It's not for those with recurrent cancer, other active metastatic diseases, severe illnesses that could affect the study, or men. Pregnant women and patients needing bilateral radiation are also excluded.

Inclusion Criteria

My cancer is in stages T1-T4c, N0-3, M0.
I can take care of myself and am up and about more than half of my waking hours.
My doctor recommends radiation therapy for my breast cancer.
See 4 more

Exclusion Criteria

My cancer has not spread from another part of my body.
I have active systemic lupus or scleroderma.
My surgery for breast cancer left some cancer cells at the edge of the removed tissue.
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Patients undergo either x-ray therapy over 25 fractions or proton beam radiation therapy over 5 fractions, with optional boost therapy

5-25 fractions
Multiple visits for each fraction

Follow-up

Participants are monitored for safety and effectiveness after treatment

5 years
Follow-up at 12 weeks, 6, 12, 24, 36 months, and 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Proton Beam Radiation Therapy
  • X-ray Therapy
Trial Overview The trial compares complications from two types of radiation therapy after breast surgery: x-ray therapy or proton beam therapy given over either 5 or more than 15 sessions. The goal is to see which treatment frequency has fewer complications when treating regional lymph nodes.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Arm II (proton beam radiation therapy)Experimental Treatment2 Interventions
Group II: Arm I (x-ray therapy)Experimental Treatment2 Interventions

Proton Beam Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

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Approved in European Union as Proton Therapy for:
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Approved in United States as Proton Therapy for:
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Approved in Canada as Proton Therapy for:
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Approved in Japan as Proton Therapy for:
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Approved in China as Proton Therapy for:
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Approved in Switzerland as Proton Therapy for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials
3,427
Recruited
3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

A large-scale randomized clinical trial is underway to compare the effects of proton therapy and photon therapy in 1278 patients with non-metastatic breast cancer, focusing on cardiovascular health and cancer control outcomes.
The primary goal is to determine if proton therapy, which reduces radiation exposure to the heart, leads to fewer major cardiovascular events compared to traditional photon therapy, potentially improving patient safety and quality of life.
Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: the Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol.Bekelman, JE., Lu, H., Pugh, S., et al.[2023]
In a phase II trial involving 38 women with early-stage breast cancer, proton therapy for partial breast irradiation achieved 100% cancer control over a median follow-up of 35 months, indicating its efficacy.
The treatment resulted in minimal adverse effects, with no severe toxicities reported, and patient-reported quality of life remained stable, supporting proton therapy as a safe option for breast cancer treatment.
Outcomes and toxicities after proton partial breast radiotherapy for early stage, hormone receptor positive breast cancer: 3-Year results of a phase II multi-center trial.Choi, JI., Prabhu, K., Hartsell, WF., et al.[2022]
Adjuvant proton beam therapy (PBT) for early breast cancer has been studied in 32 trials involving 1452 patients, showing that it may lead to fewer severe adverse events compared to traditional photon radiation therapy, particularly with scanning PBT.
The most common severe adverse effect reported after scanning PBT was dermatitis, affecting 5.7% of patients, while other severe outcomes like infection and pain were less frequent, indicating a generally favorable safety profile for PBT.
Proton Beam Therapy for Early Breast Cancer: A Systematic Review and Meta-analysis of Clinical Outcomes.Holt, F., Probert, J., Darby, SC., et al.[2023]

Citations

Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: the Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol. [2023]
Outcomes and toxicities after proton partial breast radiotherapy for early stage, hormone receptor positive breast cancer: 3-Year results of a phase II multi-center trial. [2022]
Proton Beam Therapy for Early Breast Cancer: A Systematic Review and Meta-analysis of Clinical Outcomes. [2023]
Proton versus photon radiation therapy: A clinical review. [2023]
The influence of breathing motion and a variable relative biological effectiveness in proton therapy of left-sided breast cancer. [2018]
Clinical Outcomes and Toxicity of Proton Radiotherapy for Breast Cancer. [2022]
[Dosimetric comparing between protons beam and photons beam for lung cancer radiotherapy: a meta-analysis]. [2021]
Critical appraisal of treatment techniques based on conventional photon beams, intensity modulated photon beams and proton beams for therapy of intact breast. [2019]
Novel applications of proton therapy in breast carcinoma. [2018]
10.United Statespubmed.ncbi.nlm.nih.gov
Proton beam therapy for locally advanced lung cancer: A review. [2021]
Radiation therapy planning with photons and protons for early and advanced breast cancer: an overview. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
A Technical Guide for Passive Scattering Proton Radiation Therapy for Breast Cancer. [2020]
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