RecruitingPhase 2NCT01766297

Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer


Sponsor

Proton Collaborative Group

Enrollment

132 participants

Start Date

Feb 1, 2013

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether proton beam radiation — a very precise type of radiation therapy — can safely treat only the part of the breast where cancer was removed (called partial breast irradiation), reducing side effects compared to treating the whole breast. **You may be eligible if...** - You are a woman aged 50 or older with early-stage breast cancer (Stage 0, I, or II) - You have had a lumpectomy (surgery to remove the tumor but not the whole breast) with clean margins - Your cancer is invasive ductal carcinoma or ductal carcinoma in situ (DCIS); it must be estrogen receptor positive if invasive - Your lymph nodes tested negative for cancer spread - Your tumor was 3 cm or smaller **You may NOT be eligible if...** - You have had previous breast cancer treatment on the same breast - Your cancer has spread to lymph nodes - You have the BRCA1 or BRCA2 genetic mutation - You have lobular (not ductal) breast cancer - You have HIV, lupus, scleroderma, or other collagen vascular diseases - You are pregnant or breastfeeding - Your tumor showed signs of spreading into blood or lymph vessels (lymphovascular invasion) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

RADIATIONProton Radiotherapy

Locations(9)

Mayo Clinic

Scottsdale, Arizona, United States

California Protons Cancer Therapy Center

San Diego, California, United States

Northwestern Medicine Chicago Proton Center

Warrenville, Illinois, United States

Maryland Proton Treatment Center

Baltimore, Maryland, United States

McLaren Proton Therapy Center

Flint, Michigan, United States

New York Proton Center

New York, New York, United States

Oklahoma Proton Center

Oklahoma City, Oklahoma, United States

Inova Schar Cancer Institute

Fairfax, Virginia, United States

Hampton University Proton Therapy Institute

Hampton, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT01766297


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