Proton Therapy for Breast Cancer

Overseen By Samantha Hedrick

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Thompson Cancer Survival Center

Disqualifiers: Stage IV cancer, Prior radiation, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 10 weeks

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how pencil beam scanning proton therapy affects the skin of breast cancer patients. Researchers aim to determine if a new method, "Spot Delete," can reduce skin redness during treatment. They will also use computer models to analyze how the proton beam's energy relates to skin reactions. Individuals who have undergone a lumpectomy or mastectomy for stage 0, I, II, or III breast cancer and are dealing with ductal carcinoma in-situ or invasive adenocarcinoma may be suitable candidates for this trial. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance future breast cancer treatments.

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 study team or your doctor.

What prior data suggests that this technique is safe for breast cancer patients?

Research shows that pencil beam scanning proton therapy (PBS) is generally easy for patients to handle. Previous studies have demonstrated PBS's effectiveness in controlling tumors with fewer side effects. Patients often experience milder reactions compared to other treatments.

For breast cancer, some studies suggest that PBS might reduce the total treatment time, offering a significant benefit. The therapy targets the tumor precisely with proton beams, protecting healthy tissues and reducing unwanted side effects, such as skin redness.

Overall, evidence supports PBS as a safe option for treating breast cancer, with manageable rates of serious side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Pencil Beam Scanning Proton Therapy is unique because it precisely targets breast cancer tumors with high-energy proton beams, minimizing damage to surrounding healthy tissue. Unlike traditional radiation therapy, which uses X-rays that can affect a broader area, this advanced technique allows for more accurate delivery of radiation. Researchers are excited about this treatment because it has the potential to reduce side effects and improve the quality of life for patients during and after treatment.

What evidence suggests that this technique is effective for reducing skin reactions in breast cancer patients?

Studies have shown that Pencil Beam Scanning Proton Therapy (PBS) can reduce the risk of harmful side effects compared to traditional photon therapy. Proton therapy targets cancer cells more precisely, causing less damage to healthy tissues, such as the heart and lungs, particularly in breast cancer patients. Research suggests that this method can also shorten treatment time. The "Spot Delete" technique in PBS prevents proton beams from stopping in the skin, potentially reducing skin redness and reactions. Overall, PBS is considered effective and promising for treating breast cancer while minimizing side effects. ^{1 2 6 7 8}

Who Is on the Research Team?

Samantha Hedrick, PhD

Principal Investigator

Director of Medical Physics

Are You a Good Fit for This Trial?

This trial is for adults with stage 0, I, II, or III breast cancer who've had a lumpectomy or mastectomy. They must not have prior radiation therapy to the chest, be pregnant/lactating, have certain collagen diseases like scleroderma or active dermatomyositis, Paget's disease of the nipple, Stage IV cancer, severe psychiatric conditions or other health issues that could interfere with treatment.

Inclusion Criteria

The patient must consent to be in the study and must have signed an approved consent form conforming to federal and institutional guidelines

Testing for progesterone receptors in my cancer is optional.

I don't have serious health issues that could affect my treatment.

Exclusion Criteria

I have Paget's disease of the nipple.

My breast cancer is at stage IV.

My breast cancer is not the common type but rather a rare form like sarcoma or lymphoma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pencil beam scanning proton therapy with the 'Spot Delete' technique to reduce skin reactions

10 weeks

Weekly assessments

Follow-up

Participants are monitored for skin reactions and effectiveness of the 'Spot Delete' technique post-treatment

6 months

2 visits (1-month and 6-months post-treatment)

What Are the Treatments Tested in This Trial?

Interventions

• Pencil Beam Scanning Proton Therapy

Trial Overview The study tests 'Spot Delete' in pencil beam scanning proton therapy for breast cancer patients to see if it reduces skin reactions. It involves using CT scans to guide proton beams and avoid them stopping in the skin which may cause redness.

Pencil Beam Scanning Proton Therapy is already approved in United States, European Union, Japan for the following indications:

Approved in United States as Pencil Beam Scanning Proton Therapy for:

• Breast cancer
• Brain tumors
• Spinal tumors
• Pediatric cancers

Approved in European Union as Pencil Beam Scanning Proton Therapy for:

• Breast cancer
• Brain tumors
• Spinal tumors
• Pediatric cancers
• Eye tumors

Approved in Japan as Pencil Beam Scanning Proton Therapy for:

• Breast cancer
• Brain tumors
• Spinal tumors
• Pediatric cancers
• Eye tumors
• Hepatocellular carcinoma

Who Is Running the Clinical Trial?

Thompson Cancer Survival Center

Lead Sponsor

Trials

4

Recruited

800+

Published Research Related to This Trial

In a study involving 11 patients with rectal cancer, preoperative short-course pencil beam scanning proton therapy (PBS-PT) effectively reduced radiation exposure to normal tissues compared to traditional photon therapies (3DCRT and VMAT).

PBS-PT provided similar coverage of the clinical target volume while significantly lowering the radiation dose to critical organs like the small and large bowel, bladder, and femoral heads, suggesting a safer treatment option for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Implementation of Preoperative Short-Course Pencil Beam Scanning Proton Therapy for Patients With Rectal Cancer. Jeans, EB., Jethwa, KR., Harmsen, WS., et al.[2022]

Pencil-beam scanning (PBS) technology allows for precise targeting of bulky tumors, improving the dose delivered to the tumor while minimizing exposure to surrounding healthy tissue, as demonstrated in a case study of a large retroperitoneal sarcoma.

PBS simplifies treatment planning and delivery, reduces treatment time, and lowers costs compared to traditional proton therapy methods, making it a promising option for effective radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case study in proton pencil-beam scanning delivery. Kooy, HM., Clasie, BM., Lu, HM., et al.[2018]

A novel patient-specific quality assurance (psQA) program using a high-resolution 2D strip ionization chamber array (SICA) was developed and validated for ultra-high dose rate (UHDR) FLASH proton therapy, demonstrating excellent accuracy in measuring dose and dose rate.

The SICA-based QA framework achieved high gamma passing rates (96.6% for dose and 98.8% for dose rate) compared to treatment planning system predictions, indicating its effectiveness in ensuring the safety and efficacy of FLASH radiotherapy in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of novel measurement-based patient-specific QA for pencil beam scanning proton FLASH radiotherapy. Huang, S., Yang, Y., Wei, S., et al.[2023]

Proton pencil beam scanning (PBS) therapy significantly reduces the risk of secondary cancers in breast cancer patients compared to traditional photon therapies, with a notable reduction in risk for younger patients with nodal involvement.

In a study involving 10 breast cancer patients, PBS showed a lower cumulative excess absolute risk for secondary cancers in the lungs and contralateral breast compared to tangential 3D-CRT and VMAT, highlighting its potential as a safer treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton pencil beam scanning reduces secondary cancer risk in breast cancer patients with internal mammary chain involvement compared to photon radiotherapy. Cartechini, G., Fracchiolla, F., Menegotti, L., et al.[2021]

Proton Pencil Beam Scanning (PBS) can potentially deliver high FLASH dose rates (≥40 Gy/s) effectively, but this is limited to smaller fields (less than 4x4 cm²) and requires cyclotron output currents above 500 nA.

While achieving FLASH dose rates for larger fields is challenging, local FLASH delivery to specific areas of the treatment volume is feasible, suggesting that with further research, PBS techniques can be adapted for enhanced FLASH proton radiotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current delivery limitations of proton PBS for FLASH. Zou, W., Diffenderfer, ES., Cengel, KA., et al.[2021]

The study analyzed 10 lung cancer patients and found that the motion index (MI) can predict the level of dose degradation in proton pencil beam scanning (PBS) treatment, indicating that larger tumor motion leads to greater dose errors.

Using MI as a clinical decision tool can help determine if lung cancer patients with significant tumor motion are suitable candidates for PBS treatment, potentially improving treatment planning and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study of the beam-specific interplay effect in proton pencil beam scanning delivery in lung cancer. Kang, M., Huang, S., Solberg, TD., et al.[2022]

In a study of 11 women with gynecologic cancers receiving pencil beam scanning (PBS) proton therapy, the treatment showed a low incidence of acute toxicities, with only 33% experiencing grade 2 hematologic toxicities and 9% experiencing grade 3 gastrointestinal toxicity, indicating a relatively safe profile.

PBS demonstrated significant dosimetric advantages over intensity-modulated radiation therapy (IMRT), particularly in sparing surrounding normal tissues like pelvic bone marrow, bladder, and small bowel from low doses, while maintaining robust target coverage despite setup uncertainties.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial Report of Pencil Beam Scanning Proton Therapy for Posthysterectomy Patients With Gynecologic Cancer. Lin, LL., Kirk, M., Scholey, J., et al.[2020]

In a study of 304 men with localized prostate cancer, those treated with pencil beam scanning (PBS) showed a higher proportion of significant declines in urinary quality of life (QOL) compared to those treated with passive scatter/uniform scanning (PS/US) at 12 months, indicating a potential difference in outcomes between the two proton therapy methods.

However, overall average quality-of-life declines did not significantly differ between PBS and PS/US, suggesting that while there may be specific areas of concern, both treatment modalities have similar average effects on patient-reported outcomes over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient reported outcomes following proton pencil beam scanning vs. passive scatter/uniform scanning for localized prostate cancer: Secondary analysis of PCG 001-09. Mishra, MV., Khairnar, R., Bentzen, SM., et al.[2022]

In a study of 19 children with neuroblastoma treated with pencil beam scanning proton beam therapy (PBS-PT), the early outcomes were promising, showing a 2-year overall survival rate of 94% and no local recurrences during a median follow-up of 14.9 months.

The use of volumetric rescanning (vRSC) for motion mitigation was found to be safe and feasible, although its clinical relevance may be limited for children with minimal organ motion (<5 mm) during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pencil Beam Scanning Proton Therapy for Paediatric Neuroblastoma with Motion Mitigation Strategy for Moving Target Volumes. Lim, PS., Pica, A., Hrbacek, J., et al.[2022]

Citations

1. redjournal.org redjournal.org/article/S0360-3016(25)03051-2/fulltext

Safety and Efficacy of Pencil Beam Scanning Proton ... We hypothesize that pencil beam scanning proton therapy (PBS-PBT) reRT for breast cancer recurrence provides excellent LRC with acceptable rates of high-grade ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11496198/

Proton therapy for breast cancer: Reducing toxicity - PMC In comparison with conventional photon therapy, PT offers the benefits of decreased radiation toxicity and increased dosage in the designated ...

3. newsnetwork.mayoclinic.org newsnetwork.mayoclinic.org/discussion/new-mayo-clinic-study-reveals-proton-beam-therapy-may-shorten-breast-cancer-treatment/

Mayo Clinic study reveals proton beam therapy may ... Mayo Clinic Comprehensive Cancer Center researchers uncover evidence supporting a shorter treatment time for breast cancer patients.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0360301625030512

2924 Safety and Efficacy of Pencil Beam Scanning Proton ... We hypothesize that pencil beam scanning proton therapy (PBS-PBT) reRT for breast cancer recurrence provides excellent LRC with acceptable rates of high-grade ...

5. tro.amegroups.org tro.amegroups.org/article/view/8310/html

A retrospective bilateral breast proton pencil beam scanning ... Pencil beam scanning (PBS) with protons for bilateral breast cancer patients has better sparing of the heart and lungs compared to volumetric arc therapy (VMAT)

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12427509/

Two Decades of Outcomes and Quality of Life Following ... These findings suggest that PBS PT offers effective tumor control with limited toxicity, supporting its use in children and adolescents with ...

7. cancerblog.mayoclinic.org cancerblog.mayoclinic.org/2023/10/10/mayo-clinic-study-reveals-proton-beam-therapy-may-shorten-breast-cancer-treatment/

Mayo Clinic study reveals proton beam therapy may ... Mayo Clinic Comprehensive Cancer Center researchers have uncovered evidence that supports a shorter treatment time for people with breast cancer.

8. tennesseeprotons.com tennesseeprotons.com/what-is-pencil-beam-scanning/

What Is Pencil Beam Scanning? Exploring Advanced ... Pencil beam scanning in proton therapy is particularly beneficial for tumors that are irregularly shaped, located very close to critical or sensitive organs ( ...