← Back to Search

Proton Beam Therapy

Proton Therapy for Early Stage Breast Cancer

Phase 2

Recruiting

Research Sponsored by Proton Collaborative Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Must have a lumpectomy performed, with documented negative surgical margins by 0.2 cm or more. If re-excision results in negative surgical margins 0.2 cm or more, patient is eligible.

Must have pathology proven invasive ductal carcinoma (lobular is not allowed) and/or ductal carcinoma in situ (DCIS).

Must not have

Previous history of ipsilateral invasive breast cancer or DCIS.

Any previously treated breast carcinoma or synchronous breast carcinoma in ipsilateral breast.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 3 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effects of proton radiation therapy on women with early stage breast cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed here, common side effects from proton radiotherapy may include skin reactions similar to sunburns, fatigue, swelling in the treated area (breast edema), and temporary changes in breast appearance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Select...

My breast cancer is either invasive ductal carcinoma or DCIS.

Select...

My invasive tumor, including all parts, is 3.0 cm or smaller.

Select...

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

Select...

My cancer is estrogen receptor positive.

Select...

I am female.

Select...

I am 50 years old or older.

Select...

My invasive tumor has been tested for HER2.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had breast cancer or DCIS in the same breast before.

Select...

I have had breast cancer treatment before or have cancer in the same breast now.

Select...

I do not have major infections, am not pregnant, and do not have HIV/AIDS or specific autoimmune diseases.

Select...

I have Paget's disease of the nipple.

Select...

I have suspicious calcium deposits in my breast, but they are not cancerous.

Select...

My cancer is not a common type like sarcoma or lymphoma.

Select...

I have a known BRCA 1 or BRCA 2 mutation.

Select...

I have had radiation therapy on the same side of my chest or breast before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

To assess events of freedom from ipsilateral breast recurrence occurrences in patients receiving partial breast proton radiation therapy limited to the region of the tumor.