Proton Therapy for Early Stage Breast Cancer

Not currently recruiting at 1 trial location

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Loma Linda University

Disqualifiers: Metastasis, Multicentric, Prior radiation, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of proton therapy for early-stage breast cancer. Proton therapy uses a focused beam to target cancer cells while sparing nearby healthy tissue. The trial seeks women who have undergone a lumpectomy for breast cancer tumors 3 cm or smaller, with no cancer spread to lymph nodes or other parts of the body. Participants will receive daily proton therapy for two weeks, targeting the area where the tumor was removed. As an unphased trial, this study provides participants the opportunity to contribute to innovative cancer treatment research.

Do I need to stop 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 prior data suggests that proton beam radiotherapy is safe for early stage breast cancer?

Research has shown that proton beam radiotherapy is generally manageable for patients with early-stage breast cancer. A review of 32 studies involving 1,452 patients found proton therapy to be safe. Most experienced only mild side effects, with serious reactions being less common. For example, one study reported that only 17% of patients had significant skin reactions, which are often seen with traditional radiation.

Another study found that proton therapy effectively controlled cancer while protecting nearby healthy tissues, resulting in fewer side effects compared to some other treatments. Overall, evidence suggests that proton therapy is a safe option for treating early-stage breast cancer, with many patients experiencing good results and minimal discomfort. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Proton Beam Radiotherapy is unique because it uses a precise form of radiation that targets only the tumor area, minimizing damage to surrounding healthy tissues. Unlike traditional radiation therapy, which can affect both the cancerous and healthy tissues, proton therapy delivers energy directly to the tumor site, potentially reducing side effects. Researchers are excited about this treatment for early-stage breast cancer because it promises a more focused approach, possibly leading to quicker recovery times and fewer long-term complications for patients.

What evidence suggests that proton therapy is effective for early stage breast cancer?

Research has shown that proton beam radiotherapy, administered in this trial as Partial Breast Proton Therapy, offers a promising treatment for early-stage breast cancer. Studies involving over 1,400 patients have found that this therapy effectively controls cancer with fewer side effects than some other treatments. Patients have reported excellent results, and some studies indicate a preference for proton therapy over traditional photon therapy. Additionally, research suggests that proton therapy might allow for shorter treatment times, benefiting patients. Overall, evidence suggests that proton therapy is both safe and effective for managing early-stage breast cancer. ^{1 3 4 6 7}

Who Is on the Research Team?

David A Bush, MD

Principal Investigator

Radiation Medicine - Loma Linda University Medical Center

Are You a Good Fit for This Trial?

This trial is for women aged 40 or older with early stage breast cancer that's low or intermediate risk. The tumor must be no larger than 3 cm, and they should have had a lumpectomy with clip placement and axillary node sampling showing negative margins. Women can't join if they are pregnant, breastfeeding, have certain genetic mutations like BRCA, active collagen vascular disease, distant spread of cancer (metastasis), more than one center of cancer in the same breast (multicentric disease), or previous radiation/chemotherapy.

Inclusion Criteria

I have been diagnosed with ductal carcinoma in situ (DCIS).

I am 40 years old or older.

I have been diagnosed with breast cancer.

Exclusion Criteria

My cancer has spread to my lymph nodes beyond a microscopic level.

My cancer has spread to distant parts of my body.

Pregnant or lactating

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation

Participants receive daily proton therapy delivered to the lumpectomy site

2 weeks

Daily visits for radiation therapy

Follow-up

Participants are monitored for recurrence rates and side-effects after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Proton Beam Radiotherapy

Trial Overview The trial is testing how effective and safe proton beam radiotherapy is when used as partial breast treatment in patients with early stage breast cancer. Proton therapy is a type of radiation that targets tumors more precisely to minimize damage to surrounding healthy tissue.

How Is the Trial Designed?

Group I: Partial Breast Proton Therapy Experimental Treatment 1 Intervention

Two weeks of daily proton therapy delivered to the lumpectomy site.

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10894553/

Proton Therapy in Breast Cancer: A Review of Potential ... Outcomes of proton therapy on breast cancer patients. 46% (19/41) acute G ≥ 2 RD in the conventional fractionation group and 17% (7/41) in the ...

2. redjournal.org redjournal.org/article/S0360-3016(23)00168-2/fulltext

Proton Beam Therapy for Early Breast Cancer Thirty-two studies (1452 patients) reported clinical outcomes after adjuvant PBT for early breast cancer. Median follow-up ranged from 2 to 59 ...

3. astro.org astro.org/news-and-publications/news-and-media-center/news-releases/2025/first-randomized-study-comparing-proton-and-photon-radiation-therapy-for-breast-cancer-finds-both-pr

First randomized study comparing proton and photon ... Large phase III trial shows patients report excellent outcomes after either treatment, with differences in preference favoring protons.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2452109423001628

Five-Year Outcomes of a Phase 1/2 Trial of Accelerated ... Conclusion. This prospective clinical trial demonstrates that proton APBI is feasible and safe with excellent local control in early-stage breast cancer. ...

5. 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.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0360301623001682

Proton Beam Therapy for Early Breast Cancer Thirty-two studies (1452 patients) reported clinical outcomes after adjuvant PBT for early breast cancer. Median follow-up ranged from 2 to 59 months. There ...

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 ... A condensed hypofractionated schedule of proton therapy resulted in excellent control of cancer while sparing surrounding tissue.