Proton Therapy for Early Stage Breast Cancer

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

150 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this is to determine the efficacy and toxicity of proton therapy when used to deliver partial breast radiotherapy in patients with early stage breast cancer with low or intermediate risk factors.

Research Team

David A Bush, MD

Principal Investigator

Radiation Medicine - Loma Linda University Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+