Assessing the Cosmesis and Toxicity of Partial Breast Irradiation Using Proton Beam Irradiation
Overview
- Phase
- Phase 2
- Intervention
- Accelerated Partial Breast Irradiation
- Conditions
- Breast Adenocarcinoma
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Patient-Reported Cosmesis Score
- Status
- Active, Not Recruiting
- Last Updated
- yesterday
Overview
Brief Summary
This phase II trial studies the side effects and how well radiation therapy works in treating patients with stage 0-II breast cancer. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
Detailed Description
PRIMARY OBJECTIVES: I. To assess the cosmesis, acute toxicity and late toxicity in patients treated with accelerated partial breast irradiation delivered with proton radiation. SECONDARY OBJECTIVES: I. To evaluate the convenience of accelerated partial breast irradiation and quality of life during accelerated partial breast irradiation. II. To estimate the in-breast tumor control rates in patients treated with accelerated partial breast irradiation delivered with proton radiation. III. Compare dosimetry to alternate treatment modalities. OUTLINE: Within 10 weeks of last breast cancer surgery, patients undergo accelerated partial breast irradiation (APBI) delivered with proton radiation twice daily (BID) for 5 days. After completion of study treatment, patients are followed up at 6 weeks, 6 months, 1 year, and 18 months, then annually for 10 years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women who satisfy all of the following conditions are the only patients who will be eligible for this study.
- •The patient must consent to be in the study and must have signed an approved consent form conforming with federal and institutional guidelines.
- •Patients must be \>/= 18 years old. (Adenocarcinoma of the breast is not seen in children)
- •English and non-English speaking patient
- •The patient must have stage 0, I, or II breast cancer. If stage II, the tumor size must be 3 cm or less.
- •On histological examination, the tumor must be DCIS or invasive adenocarcinoma of the breast.
- •Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (DCIS and invasive).
- •Re-excision of surgical margins is permitted.
- •Gross disease must be unifocal with pathologic (invasive and/or DCIS) tumor size 3 cm or less. (Patients with microscopic multifocality are eligible as long as total pathologic tumor size is 3 cm or less.)
- •Patients with invasive breast cancer are required to have axillary staging which can include sentinel node biopsy alone (if sentinel node is negative), sentinel node biopsy followed by axillary dissection or sampling with a minimum total of 6 axillary nodes (if sentinel node is positive), or axillary dissection alone (with a minimum of 6 axillary nodes). Axillary staging is not required for patients with DCIS.
Exclusion Criteria
- •Women with one or more of the following conditions also are ineligible for this study.
- •Men are not eligible for this study.
- •Individuals that are considered to be cognitively impaired.
- •T2 (\> 3.0 cm), T3, stage III, or stage IV breast cancer.
- •More than 3 histologically positive axillary nodes.
- •Axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension.
- •Palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes at time of enrollment unless there is histologic confirmation that these nodes are negative for tumor.
- •Suspicious microcalcifications, or densities (in the ipsilateral or contralateral breast as documented on mammogram or breast ultrasound) unless biopsied and found to be benign.
- •Non-epithelial breast malignancies such as sarcoma or lymphoma.
- •Proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by 4 or more centimeters.
Arms & Interventions
Treatment (APBI)
Within 10 weeks of last breast cancer surgery, patients undergo APBI delivered with proton radiation BID for 5 days.
Intervention: Accelerated Partial Breast Irradiation
Treatment (APBI)
Within 10 weeks of last breast cancer surgery, patients undergo APBI delivered with proton radiation BID for 5 days.
Intervention: Proton Beam Radiation Therapy
Treatment (APBI)
Within 10 weeks of last breast cancer surgery, patients undergo APBI delivered with proton radiation BID for 5 days.
Intervention: Quality-of-Life Assessment
Outcomes
Primary Outcomes
Patient-Reported Cosmesis Score
Time Frame: 1 year
Patient-reported cosmesis score on the Breast Cancer Treatment Outcomes Scale (BCTOS) at 1 year. Cosmesis scores range from 1 (excellent) to 4 (poor), and scores of 3 (fair) or more indicate adverse cosmetic outcomes.
Secondary Outcomes
- Rate of CTCAE Grade 3+ Confluent Moist Desquamation(Within 6 weeks of radiation therapy)
- Percent of Patients with Local Failure(10 years)