Partial Breast Re-Irradiation for Patients With Ipsilateral Breast Tumor Recurrence, After First Being Treated With Breast Conservation for Early Stage Breast Cancer: An Efficacy Trial Comparing Mammosite® and Intraoperative Radiation
18 Years
N/A
Both
Breast Cancer
Trial Information
Partial Breast Re-Irradiation for Patients With Ipsilateral Breast Tumor Recurrence, After First Being Treated With Breast Conservation for Early Stage Breast Cancer: An Efficacy Trial Comparing Mammosite® and Intraoperative Radiation
OBJECTIVES:
- To determine the in breast recurrence rate following repeat radiation to the breast
with Mammosite® brachytherapy or intraoperative radiotherapy in patients with recurrent
ipsilateral breast cancer.
- To determine the cosmetic outcome resulting from partial breast re-irradiation using
different techniques, including both physician- and patient-rated scales.
- To determine patient satisfaction of partial breast re-irradiation as it pertains to
their overall treatment experience, as measured by a questionnaire.
- To determine if there are patient factors which limit a patient's suitability to
receive partial breast re-irradiation delivered by a particular technique.
- To evaluate tylectomy wound healing and overall complication rate after partial breast
re-irradiation.
- To determine ipsilateral breast tumor recurrence rates and tumor bed recurrence rates.
OUTLINE: Patients are stratified according to which modality is best suited for the patient.
Patients are assigned to 1 of 2 groups.
All patients undergo excisional biopsy or needle localization removal of the tumor. Patients
with margins < 2 mm undergo re-excision of the biopsy cavity.
- Group 1: Patients undergo partial breast irradiation delivered as a single
intra-operative radiation dose to the tumor bed.
- Group 2: Patients undergo partial breast irradiation delivered by Mammosite®
brachytherapy consisting of 10 fractions over 5 days.
Quality of life is assessed at baseline, 1 month after completion of radiotherapy, and then
at follow-up visits.
After completion of study treatment, patients are followed up at 1 month, every 3 months for
1 year, and then every 6 months for 5 years.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed ductal carcinoma in situ (DCIS) or invasive carcinoma of the
breast (ductal, medullary, papillary, colloid [mucinous], or tubular) meeting the
following criteria:
- Lesion size ≤ 3 cm treated with a tylectomy and whole breast irradiation (with
or without tumor bed boost)
- Unifocal breast cancer recurrence
- Negative resection margins with ≥ a 2 mm margin from invasive and in situ cancer
or a negative re-excision
- Patients with clinically and radiographically negative axillas should not undergo an
axillary lymph node dissection unless they did not have prior axillary lymph node
sampling (i.e., previous cancer was DCIS)
- No invasive lobular carcinoma, extensive lobular carcinoma in situ, extensive DCIS (≥
3 cm), or nonepithelial breast malignancies such as lymphoma or sarcoma
- 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 or cytologically confirmed negative
- No extensive intraductal component by the Harvard definition, i.e., more than 25% of
the invasive tumor is DCIS and DCIS present in adjacent breast tissue
- No distant metastatic disease
- No Paget's disease of the nipple
- No skin involvement
- No known BRCA1/BRCA2 mutations
- Hormone receptor status not specified
PATIENT CHARACTERISTICS:
- Menopausal status not specified
- No collagen vascular disorders, i.e., systemic lupus erythematosus, scleroderma, or
dermatomyositis
- No psychiatric, neurologic, or addictive disorders that would preclude study
participation
- No other malignancy within the past 5 years except nonmelanoma skin cancer
- Not pregnant or nursing
- Negative pregnancy test
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 5 years since prior radiotherapy
- No chemotherapy within 2 weeks after completion of radiotherapy
- Concurrent hormonal therapy allowed
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Ipsilateral breast tumor recurrence rates
Outcome Time Frame:
Every three months during the first year and every 6 months thereafter for 5 years.
Safety Issue:
No
Principal Investigator
Janice Lyons, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CASE11107
NCT ID:
NCT00945061
Start Date:
September 2008
Completion Date:
Related Keywords:
- Breast Cancer
- ductal breast carcinoma in situ
- recurrent breast cancer
- invasive ductal breast carcinoma
- medullary ductal breast carcinoma with lymphocytic infiltrate
- mucinous ductal breast carcinoma
- papillary ductal breast carcinoma
- tubular ductal breast carcinoma
- male breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| 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 |
