Proton Therapy for Early Stage Breast Cancer

Recruiting at 8 trial locations

Overseen By Edith Maritato

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Proton Collaborative Group

Disqualifiers: Previous breast cancer, Bilateral disease, Pregnancy, HIV/AIDS, 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

132 Participants Needed

Trial Summary

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

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 Therapy for Early Stage Breast Cancer?

Research shows that proton therapy for early-stage breast cancer can reduce the risk of damage to nearby organs like the heart and lungs compared to traditional radiation methods. Early results from clinical trials suggest it has acceptable side effects and may improve cosmetic outcomes, but more studies are needed to confirm these benefits. ^{1 2 3 4 5}

Is proton therapy safe for treating early-stage breast cancer?

Proton 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 2 4 6 7}

How is proton therapy different from other treatments for early stage breast cancer?

Proton therapy is unique because it delivers radiation that stops at the tumor, reducing exposure to nearby healthy tissues like the heart and lungs. This can lead to fewer side effects and potentially better cosmetic outcomes compared to traditional radiation methods. ^{1 3 4 5 8}

What is the purpose of this trial?

The purpose of this research study is to compare the effects (good and bad) on women and their cancer using proton radiation therapy. This study is being done to see if proton radiation therapy will prove to be beneficial for women with early stage breast cancer. A clinical study is necessary to compare the results (good or bad) of proton radiation therapy.

Research Team

Andrew Chang, MD

Principal Investigator

Proton Collaborative Group

Eligibility Criteria

This trial is for women aged 50 or older with early stage breast cancer (Stage 0, I, II) that's ER positive and up to 3.0 cm in size. They must have had a lumpectomy with clear margins and be able to start treatment within specific time frames post-surgery or chemotherapy. Women with invasive lobular histology, previous ipsilateral breast cancer, significant infections, certain genetic mutations like BRCA1/2, or prior chest radiation are excluded.

Inclusion Criteria

I had a lumpectomy with clear margins of at least 0.2 cm.

I understand the requirements for markers or clips for my treatment positioning.

My breast cancer is early stage (0, I, or II) and if stage II, my tumor is 3.0 cm or smaller.

Exclusion Criteria

Your pathology test shows that cancer has spread to the lymphovascular space.

Pregnant or lactating.

You have any suspicious-looking lumps or nodes that haven't been confirmed as harmless through a biopsy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive proton radiotherapy with 4.0 Gy (RBE) x10 fractions to a total dose of 40 Gy (RBE)

2 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Treatment Details

Interventions

• Proton Radiotherapy

Trial Overview The study tests the effectiveness of proton radiotherapy on women with early stage breast cancer. It aims to determine if this type of targeted radiation therapy results in fewer side effects while being as effective as traditional treatments.

Participant Groups

Group I: Proton Radiotherapy Experimental Treatment 1 Intervention

Proton Radiotherapy 4.0 Gy (RBE) x10 fractions to 40 Gy (RBE) Total Dose

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

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]

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]

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 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]

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]

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]

Proton beam radiation therapy may be beneficial for adolescent and young adult cancer patients by potentially reducing radiation exposure to healthy tissues, which could lower the risk of side effects after treatment.

Current literature suggests that proton therapy is effective for treating specific cancers like central nervous system tumors and Hodgkin lymphoma, but further research is needed to fully establish its role and benefits in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proton Therapy in the Adolescent and Young Adult Population. Ahmed, SK., Keole, SR.[2023]

Proton therapy offers a significant advantage in treating locally advanced breast cancer by delivering precise radiation doses that minimize damage to surrounding healthy tissues.

The review discusses important clinical and technical aspects of proton radiotherapy, emphasizing its potential to reduce treatment-related side effects for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Potential of Proton Therapy for Locally Advanced Breast Cancer: Clinical and Technical Considerations. Lalani, N., Alqarni, S., Jimenez, RB.[2023]

References

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

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

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

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

3. 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]

4. China pubmed.ncbi.nlm.nih.gov

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

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

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

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

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

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

Proton Therapy in the Adolescent and Young Adult Population. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

The Potential of Proton Therapy for Locally Advanced Breast Cancer: Clinical and Technical Considerations. [2023]