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

Sponsor: Proton Collaborative Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT01766297

Provider View

This clinical trial is exploring the use of proton radiation therapy to treat women with early stage breast cancer. The study aims to determine if this type of radiation therapy is beneficial compared to traditional methods.

Patient Parameters

Program Overview

The purpose of this study is to see if proton radiation therapy can be a good option for women with early stage breast cancer. Currently, the standard treatment involves surgery and radiation to the whole breast. However, most cancer recurrences happen near the original tumor site, raising the question of whether full breast radiation is necessary. By focusing radiation only on the area where the tumor was, it might reduce side effects and make treatment more convenient and affordable. This study will compare proton therapy, which may limit radiation exposure to healthy tissue, with other methods to see if it is safe and effective.

Description

For early stage breast cancer, the usual treatment is surgery followed by radiation to the whole breast. However, since most recurrences happen near the original tumor site, some believe that targeting only that area with radiation might be enough. This approach could reduce side effects and make treatment easier and cheaper.

There are different ways to do partial breast irradiation (PBI), such as using catheters or balloons to deliver radiation directly to the tumor site, or using external beam radiation therapy (EBRT). Proton therapy is a type of EBRT that might offer the same benefits while reducing radiation to healthy tissue. However, there is limited data on its use for PBI, so this study aims to explore its feasibility, safety, and effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Must sign a study-specific consent form before joining the study.
  • Must be female and at least 50 years old.
  • Must have a life expectancy of at least 5 years.
  • Must have a confirmed diagnosis of invasive ductal carcinoma or ductal carcinoma in situ (DCIS).
  • Tumors must be 3.0 cm or smaller and meet specific criteria regarding their location and type.
  • Must be at Stage 0, I, or II, with specific size and node involvement criteria.
  • Must have estrogen receptor (ER) positive disease.
  • Must have had a lumpectomy with clear surgical margins.
  • Must be able to start treatment within 12 weeks of surgery or 8 weeks after chemotherapy.

Exclusion Criteria

  • Previous history of breast cancer on the same side.
  • Suspicious lymph nodes unless proven benign.
  • Non-epithelial cancers like sarcoma or lymphoma.
  • Suspicious microcalcifications unless proven non-cancerous.
  • Multiple tumors in different areas or in both breasts unless proven non-cancerous.
  • Lymphovascular space invasion.
  • Previous breast cancer treatment on the same side.
  • Paget's disease of the nipple.
  • Invasive lobular cancer.
  • Skin involvement.
  • Breasts not suitable for radiation treatment.
  • Significant infections or medical conditions like pregnancy or autoimmune diseases.
  • Known BRCA 1 or BRCA 2 mutation.
  • Pregnant or breastfeeding.

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