Proton Beam vs X-ray Radiation Therapy for Breast Cancer
Recruiting in Palo Alto (17 mi)
+2 other locations
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Mayo Clinic
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
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.
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.
12345What 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.
16789Is 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.
39101112Eligibility Criteria
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.
+5 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.
+10 more
Participant Groups
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.
2Treatment groups
Experimental Treatment
Group I: Arm II (proton beam radiation therapy)Experimental Treatment2 Interventions
Within 12 weeks of the last breast cancer surgery or last dose of adjuvant chemotherapy and no sooner than 14 days since the last chemotherapy, patients undergo proton beam radiation therapy over 5 fractions in the absence of disease progression or unacceptable toxicity. Optionally, patients may receive a concurrent 5-fraction boost of proton beam radiation therapy.
Group II: Arm I (x-ray therapy)Experimental Treatment2 Interventions
Within 12 weeks of the last breast cancer surgery or last dose of adjuvant chemotherapy and no sooner than 14 days since the last chemotherapy, patients undergo x-ray therapy over 25 fractions in the absence of disease progression or unacceptable toxicity. Optionally, patients may then receive a 4-fraction boost of x-ray therapy.
Proton Beam Radiation Therapy is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:
🇪🇺 Approved in European Union as Proton Therapy for:
- Esophageal adenocarcinoma
- Esophageal squamous cell carcinoma
- Gastroesophageal junction tumors
🇺🇸 Approved in United States as Proton Therapy for:
- Esophageal adenocarcinoma
- Esophageal squamous cell carcinoma
- Gastroesophageal junction tumors
🇨🇦 Approved in Canada as Proton Therapy for:
- Esophageal adenocarcinoma
- Esophageal squamous cell carcinoma
- Gastroesophageal junction tumors
🇯🇵 Approved in Japan as Proton Therapy for:
- Esophageal adenocarcinoma
- Esophageal squamous cell carcinoma
- Gastroesophageal junction tumors
🇨🇳 Approved in China as Proton Therapy for:
- Esophageal adenocarcinoma
- Esophageal squamous cell carcinoma
- Gastroesophageal junction tumors
🇨🇭 Approved in Switzerland as Proton Therapy for:
- Esophageal adenocarcinoma
- Esophageal squamous cell carcinoma
- Gastroesophageal junction tumors
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Mayo Clinic in ArizonaScottsdale, AZ
Mayo Clinic in FloridaJacksonville, FL
Mayo Clinic in RochesterRochester, MN
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Who Is Running the Clinical Trial?
Mayo ClinicLead Sponsor
National Cancer Institute (NCI)Collaborator
References
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]A broad range of stakeholders have called for randomised evidence on the potential clinical benefits and harms of proton therapy, a type of radiation therapy, for patients with breast cancer. Radiation therapy is an important component of curative treatment, reducing cancer recurrence and extending survival. Compared with photon therapy, the international treatment standard, proton therapy reduces incidental radiation to the heart. Our overall objective is to evaluate whether the differences between proton and photon therapy cardiac radiation dose distributions lead to meaningful reductions in cardiac morbidity and mortality after treatment for breast cancer.
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 therapy (PT) for partial breast irradiation (PBI) in early-stage breast cancer can decrease morbidity versus photon PBI with superior organs-at-risk sparing. We report 3-year outcomes of the first prospective, multicenter, phase II trial of proton PBI.
Proton Beam Therapy for Early Breast Cancer: A Systematic Review and Meta-analysis of Clinical Outcomes. [2023]Adjuvant proton beam therapy (PBT) is increasingly available to patients with breast cancer. It achieves better planned dose distributions than standard photon radiation therapy and therefore may reduce the risks. However, clinical evidence is lacking.
Proton versus photon radiation therapy: A clinical review. [2023]While proton radiation therapy offers substantially better dose distribution characteristics than photon radiation therapy in certain clinical applications, data demonstrating a quantifiable clinical advantage is still needed for many treatment sites. Unfortunately, the number of patients treated with proton radiation therapy is still comparatively small, in some part due to the lack of evidence of clear benefits over lower-cost photon-based treatments. This review is designed to present the comparative clinical outcomes between proton and photon therapies, and to provide an overview of the current state of knowledge regarding the effectiveness of proton radiation therapy.
The influence of breathing motion and a variable relative biological effectiveness in proton therapy of left-sided breast cancer. [2018]Proton breast radiotherapy has been suggested to improve target coverage as well as reduce cardiopulmonary and integral dose compared with photon therapy. This study aims to assess this potential when accounting for breathing motion and a variable relative biological effectiveness (RBE).
Clinical Outcomes and Toxicity of Proton Radiotherapy for Breast Cancer. [2022]Proton beam radiotherapy (PBT) represents a rapidly expanding modality for the treatment of several malignancies. We examined the current state of PBT for breast cancer to evaluate its role in the modern era of breast radiotherapy. Systematic searches were performed using PubMed, EMBASE, and abstracts from the American Society for Radiation Oncology, American Society of Clinical Oncology, and Particle Therapy Co-Operative Group of North America annual meetings, using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Nine original investigations were analyzed. Despite the dearth of overall data, skin toxicity after PBT might be equivalent or better than that of photons. Conventionally fractionated breast/chest wall PBT produces grade 1 dermatitis rates of approximately 25% and grade 2 dermatitis in 71% to 75%. This is comparable or improved over the published rates for photons. The incidence of esophagitis was decreased if the target coverage was compromised in the medial supraclavicular volume, a finding that echoes previous results with photon radiotherapy. The rates of esophagitis were also comparable to the previous data for photons. Using PBT-based accelerated partial breast irradiation, the rates of seroma/hematoma and fat necrosis were comparable to those reported in the existing data. Radiation pneumonitis and rib fractures remain rare. PBT offers excellent potential to minimize the risk of cardiac events, keeping the mean heart dose at ≤ 1 Gy. However, definitive clinical experiences remain sparse. The recently begun randomized trial of protons versus photons will further aid in providing robust conclusions.
[Dosimetric comparing between protons beam and photons beam for lung cancer radiotherapy: a meta-analysis]. [2021]The clinical evidences are not sufficient on the proton beam therapy of lung cancer for lacking of the RCTs on the comparing the proton with the photon beam in lung cancer radiotherapy. The aim of this study is to evaluate the dosimetry superiority of the proton beam and provide more valuable evidences to the clinical researches.
Critical appraisal of treatment techniques based on conventional photon beams, intensity modulated photon beams and proton beams for therapy of intact breast. [2019]To analyse different treatment techniques with conventional photon beams, intensity modulated photon beams, and proton beams for intact breast irradiation for patients in whom conventional irradiation would cause potentially dangerous lung irradiation.
Novel applications of proton therapy in breast carcinoma. [2018]This review will focus on the indications, clinical experience, and technical considerations of proton beam radiation therapy in the treatment of patients with breast cancer. For patients with early stage disease, proton therapy delivers less dose to non-target breast tissue for patients receiving partial breast irradiation (PBI) therapy, which may result in improved cosmesis but requires further investigation. For patients with locally advanced breast cancer requiring treatment to the regional lymph nodes, proton therapy allows for an improved dosimetric profile compared with conventional photon and electron techniques. Early clinical results demonstrate acceptable toxicity. The possible reduction in cardiopulmonary events as a result of reduced dose to organs at risk will be tested in a randomized control trial of protons vs. photons.
Proton beam therapy for locally advanced lung cancer: A review. [2021]Protons interact with human tissue differently than do photons and these differences can be exploited in an attempt to improve the care of lung cancer patients. This review examines proton beam therapy (PBT) as a component of a combined modality program for locally advanced lung cancers. It was specifically written for the non-radiation oncologist who desires greater understanding of this newer treatment modality. This review describes and compares photon (X-ray) radiotherapy (XRT) to PBT. The physical differences of these beams are described and the clinical literature is reviewed. Protons can be used to create treatment plans delivering significantly lower doses of radiation to the adjacent organs at risk (lungs, esophagus, and bone marrow) than photons. Clinically, PBT combined with chemotherapy has resulted in low rates of toxicity compared to XRT. Early results suggest a possible improvement in survival. The clinical results of proton therapy in lung cancer patients reveal relatively low rates of toxicity and possible survival benefits. One randomized study is being performed and another is planned to clarify the clinical differences in patient outcome for PBT compared to XRT. Along with the development of better systemic therapy, newer forms of radiotherapy such as PBT should positively impact the care of lung cancer patients. This review provides the reader with the current status of this new technology in treating locally advanced lung cancer.
Radiation therapy planning with photons and protons for early and advanced breast cancer: an overview. [2018]Postoperative radiation therapy substantially decreases local relapse and moderately reduces breast cancer mortality, but can be associated with increased late mortality due to cardiovascular morbidity and secondary malignancies. Sophistication of breast irradiation techniques, including conformal radiotherapy and intensity modulated radiation therapy, has been shown to markedly reduce cardiac and lung irradiation. The delivery of more conformal treatment can also be achieved with particle beam therapy using protons. Protons have superior dose distributional qualities compared to photons, as dose deposition occurs in a modulated narrow zone, called the Bragg peak. As a result, further dose optimization in breast cancer treatment can be reasonably expected with protons. In this review, we outline the potential indications and benefits of breast cancer radiotherapy with protons. Comparative planning studies and preliminary clinical data are detailed and future developments are considered.
A Technical Guide for Passive Scattering Proton Radiation Therapy for Breast Cancer. [2020]Most patients treated with proton therapy have had eye tumors, sarcomas, or, more recently, pediatric, or prostate cancers. As more proton centers have developed globally, increased capacity will permit exploration of other potential indications for proton therapy, including for the treatment of breast cancer. The rationale for proton therapy in the treatment of breast cancer is reduced inadvertent radiation dose to the heart and lung, as well as improved target coverage. As with any new technology, multiple technical parameters require optimization to deliver safe and effective radiation therapy and to maximize the benefits of the new technology. The purpose of this report is to provide a technical guide for the treatment of breast cancer with passive-scattering proton therapy and an algorithm for selecting patients with breast cancer who would benefit from proton therapy.