Proton Radiation for Breast Cancer

Recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Proton Collaborative Group

Disqualifiers: Weight, Prior radiation, Pregnancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

220 Participants Needed

Trial Summary

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 coordinators or your doctor.

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

Proton therapy for breast cancer can reduce radiation exposure to the heart and lungs compared to traditional methods, potentially lowering the risk of heart and lung problems. Early studies show it may also lead to fewer side effects and better outcomes for patients with early-stage breast cancer. ^{1 2 3 4 5}

Is proton radiation therapy safe for breast cancer patients?

Proton radiation therapy for breast cancer shows similar or better skin safety compared to traditional photon therapy, with rare occurrences of lung inflammation and rib fractures. It also has the potential to reduce heart-related risks by keeping the heart's radiation exposure low. ^{1 6 7 8 9}

How is proton radiation treatment different from other treatments for breast cancer?

Proton radiation treatment for breast cancer is unique because it delivers radiation more precisely to the tumor, reducing exposure to nearby healthy tissues like the heart and lungs. This precision may lower the risk of side effects and improve cosmetic outcomes, but more research is needed to confirm these benefits. ^{1 4 5 8 9}

What is the purpose of this trial?

The purpose of this study is to look at the rates of acute and long term adverse events of postoperative proton radiotherapy for complex loco-regional irradiation in women with loco-regionally advanced breast cancer. This study specifically includes longitudinal follow up to assess the incidence of cardiac mortality and second malignant neoplasms at 10 and 15 years following proton therapy(PT).

Research Team

Eugen Hug, MD

Principal Investigator

Proton Collaborative Group

Eligibility Criteria

This trial is for women over 18 with stage II/III breast cancer who've had surgery like a mastectomy or lumpectomy. They should expect to live at least another 10 years and agree to use non-hormonal contraception if of childbearing potential. Excluded are those with certain psychiatric, collagen diseases, pregnancy, weight over 410 pounds, large breast size unsuitable for treatment setup, prior non-breast cancers (with exceptions), unclear surgical margins without re-excision clearance, temporary breast expanders depending on assessment, previous chest radiation therapy, non-epithelial breast malignancies or a history of breast cancer.

Inclusion Criteria

I have multicentric breast cancer or Paget's disease of the nipple.

I have undergone surgery for breast cancer, like mastectomy or lumpectomy.

My breast cancer is confirmed by tests and is of a specific type (invasive ductal or lobular).

Exclusion Criteria

Your breast size is too large for the treatment setup process.

Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.

I have had radiation therapy to my chest area before.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive postoperative, cardiac-sparing proton radiotherapy for loco-regional breast cancer

6-8 weeks

Follow-up

Participants are monitored for safety and effectiveness, focusing on cardiac mortality and second malignant neoplasms

10-15 years

Treatment Details

Interventions

• Proton Radiotherapy

Trial Overview The study tests postoperative proton radiotherapy's safety and long-term effects in advanced-stage breast cancer patients. It aims to monitor acute side effects and the risk of heart-related deaths and secondary cancers after up to 15 years following treatment.

Participant Groups

Group I: Proton Radiotherapy Experimental Treatment 1 Intervention

Proton Radiotherapy

Proton Radiotherapy is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Proton Therapy for:

• Early-stage breast cancer
• Locally advanced breast cancer
• Recurrent breast cancer

Approved in European Union as Proton Therapy for:

• Breast cancer
• Early-stage breast cancer
• Locally advanced breast cancer

Approved in Canada as Proton Therapy for:

• Breast cancer
• Early-stage breast cancer

Approved in Japan as Proton Therapy for:

• Breast cancer

Who Is Running the Clinical Trial?

Proton Collaborative Group

Lead Sponsor

Trials

10

Recruited

41,100+

Findings from Research

Proton beam radiation therapy for early-stage breast cancer may improve cosmetic outcomes by delivering a lower dose to non-target breast tissue during partial breast irradiation, although more research is needed to confirm these benefits.

In patients with locally advanced breast cancer, proton therapy shows a better dosimetric profile compared to traditional photon and electron techniques, with early clinical results indicating acceptable levels of toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel applications of proton therapy in breast carcinoma. Cuaron, JJ., MacDonald, SM., Cahlon, O.[2018]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Proton therapy is being explored as a treatment option for breast cancer due to its ability to reduce radiation exposure to the heart and lungs while improving coverage of the tumor target.

This report provides a technical guide and patient selection algorithm to optimize the safe and effective use of passive-scattering proton therapy for breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Technical Guide for Passive Scattering Proton Radiation Therapy for Breast Cancer. Bradley, JA., Ho, MW., Li, Z., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a study of 30 breast cancer patients treated with postoperative proton therapy, the treatment was well tolerated, with a median dose of 50.4 Gy delivered over 5 weeks and no patients requiring a treatment break.

While 71.4% of patients experienced grade 2 dermatitis and 28.6% had grade 2 esophagitis, the therapy effectively spared normal tissues, showing a median heart dose of only 0.88 Gy, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early toxicity in patients treated with postoperative proton therapy for locally advanced breast cancer. Cuaron, JJ., Chon, B., Tsai, H., et al.[2018]

Proton beam radiotherapy (PBT) for breast cancer shows promising results, with skin toxicity rates (grade 1 dermatitis at ~25% and grade 2 dermatitis at 71-75%) comparable or better than traditional photon therapy.

PBT has the potential to significantly reduce cardiac risks by keeping the mean heart dose at ≤ 1 Gy, although more definitive clinical data is needed, and ongoing randomized trials will help clarify its efficacy compared to photon therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes and Toxicity of Proton Radiotherapy for Breast Cancer. Verma, V., Shah, C., Mehta, MP.[2022]

In a phase II trial involving 50 women with early-stage breast cancer, proton beam irradiation for partial breast radiotherapy after lumpectomy demonstrated excellent safety, with minimal treatment-related toxicities such as mild radiation dermatitis and no serious complications like infections or cardiac events.

The treatment showed high efficacy, with 5-year overall survival and disease-free survival rates of 96% and 92%, respectively, and no local failures, indicating that proton therapy is a promising option for breast cancer treatment with reduced risk to surrounding healthy tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Partial breast irradiation delivered with proton beam: results of a phase II trial. Bush, DA., Slater, JD., Garberoglio, C., et al.[2018]

References

1. China pubmed.ncbi.nlm.nih.gov

Novel applications of proton therapy in breast carcinoma. [2018]

2. Ireland pubmed.ncbi.nlm.nih.gov

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]

3. England pubmed.ncbi.nlm.nih.gov

Proton therapy for early breast cancer patients in the DBCG proton trial: planning, adaptation, and clinical experience from the first 43 patients. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A Technical Guide for Passive Scattering Proton Radiation Therapy for Breast Cancer. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Proton Beam Therapy for Early Breast Cancer: A Systematic Review and Meta-analysis of Clinical Outcomes. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Early toxicity in patients treated with postoperative proton therapy for locally advanced breast cancer. [2018]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Proton therapy for isolated local regional recurrence of breast cancer after mastectomy alone. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Clinical Outcomes and Toxicity of Proton Radiotherapy for Breast Cancer. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Partial breast irradiation delivered with proton beam: results of a phase II trial. [2018]