Partial Breast Irradiation for Patients Undergoing Breast Conservation Therapy for Early Stage Breast Cancer: A Pilot Study
18 Years
N/A
Female
Breast Cancer
Trial Information
Partial Breast Irradiation for Patients Undergoing Breast Conservation Therapy for Early Stage Breast Cancer: A Pilot Study
OBJECTIVES:
- To determine the cosmetic outcome resulting from partial breast irradiation using two
different techniques.
- To determine patient satisfaction with partial breast irradiation as it pertains to
their overall treatment experience as measured by a questionnaire.
- To determine if there are patient factors that limit a patient's suitability to receive
partial breast irradiation delivered by a particular technique.
- To evaluate wound healing and overall complication rate after partial breast
irradiation.
- To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.
OUTLINE: Patients undergo partial breast irradiation comprising either MammoSite®
brachytherapy twice daily for 5-10 days OR 3-dimensional conformal radiotherapy twice daily
for 5-10 days.
After completion of study therapy, patients are followed periodically for up to 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed breast cancer, including the following histologic subtypes:
- Invasive ductal carcinoma
- Medullary ductal carcinoma
- Papillary ductal carcinoma
- Colloid (mucinous) ductal carcinoma
- Tubular ductal carcinoma
- The following histologic subtypes are not allowed:
- Invasive lobular carcinoma
- Extensive lobular carcinoma in situ
- Ductal carcinoma in situ (DCIS)
- Nonepithelial breast malignancies, such as lymphoma or sarcoma
- No extensive intraductal component by Harvard definition (i.e., more than 25% of the
invasive tumor is DCIS or DCIS present in adjacent tissue)
- Stage I or II disease (T1, N0; T1, N1a; T2, N0; or T2, N1a)
- Lesion ≤ 3 cm
- No more than 3 positive lymph nodes
- Patients with 4 or more positive axillary lymph nodes found at the time of
axillary lymph node dissection/sentinel lymph node biopsy are not eligible
- Has undergone tylectomy (lumpectomy) and axillary lymph node sampling (axillary node
dissection or sentinel node biopsy)
- Negative resection margins with ≥ 2 mm margin from invasive or in situ cancer OR
a negative re-excision margin
- Unifocal breast cancer
- No multicentric carcinoma (tumors in different quadrants of the breast or tumors
separated by ≥ 4 cm)
- No palpable or radiographically suspicious contralateral axillary,
ipsilateral or contralateral supraclavicular, infraclavicular, or internal
mammary lymph nodes unless these are histologically confirmed negative
- No skin involvement of disease
- No Paget's disease of the nipple
- No distant metastatic disease
- Hormone-receptor status not specified
PATIENT CHARACTERISTICS:
- Female
- Menopausal status not specified
- Not pregnant or lactating
- Negative pregnancy test
- Fertile patients must use effective contraception for ≥ 1 week prior to, during, and
for ≥ 2 weeks after completion of study treatment
- No collagen vascular disorders, specifically systemic lupus erythematosus,
scleroderma, or dermatomyositis
- No psychiatric, neurologic, or addictive disorders that would preclude obtaining
informed consent
- No other malignancy within the past 5 years, except non-melanomatous skin cancer
PRIOR CONCURRENT THERAPY:
- No prior radiotherapy to the breast
- No chemotherapy for at least 2 weeks before and 2 weeks after completion of study
radiotherapy
- Concurrent hormonal therapy allowed
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon
Outcome Time Frame:
1 month after RT & Q3mos for one year
Safety Issue:
No
Principal Investigator
Janice Lyons, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CASE2104
NCT ID:
NCT00527293
Start Date:
June 2007
Completion Date:
October 2014
Related Keywords:
- Breast Cancer
- stage I breast cancer
- stage II breast cancer
- invasive ductal breast carcinoma
- medullary ductal breast carcinoma with lymphocytic infiltrate
- mucinous ductal breast carcinoma
- tubular ductal breast carcinoma
- papillary ductal breast carcinoma
- Breast Neoplasms
Name | Location |
|---|---|
| Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| UHHS Chagrin Highlands Medical Center | Orange Villager, Ohio 44122 |
| UHHS Westlake Medical Center | Westlaker, Ohio 44145 |
