An Early Phase 1 interventional study of adjuvant therapy and 3-dimensional conformal radiation therapy in Breast Cancer, sponsored by Case Comprehensive Cancer Center. Completed at 4 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-08-25.
Sponsored by Case Comprehensive Cancer Center · Early Phase 1, Interventional, and Supportive care
RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in treating women undergoing breast-conserving therapy for early stage breast cancer.
OBJECTIVES:
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.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 29 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.
Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer, including the following histologic subtypes:
The following histologic subtypes are not allowed:
Stage I or II disease (T1, N0; T1, N1a; T2, N0; or T2, N1a)
No more than 3 positive lymph nodes
Has undergone tylectomy (lumpectomy) and axillary lymph node sampling (axillary node dissection or sentinel node biopsy)
Unifocal breast cancer
No multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by ≥ 4 cm)
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days
Procedure: adjuvant therapy · Radiation: brachytherapy
3-dimensional conformal radiotherapy twice daily for 5-10 days.
Procedure: adjuvant therapy · Radiation: 3-dimensional conformal radiation therapy
If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation. If chemotherapy is given first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation.
3-dimensional conformal radiotherapy twice daily for 5-10 days.
Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days
Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon
Time frame: 1 month after RT & Q3mos for one year
Patient satisfaction with partial breast irradiation as measured by a questionnaire
Time frame: Pre-treatment 1 mo 3 mo 6 mo 9 mo 1yr 5 yr
Wound healing and overall complication rate after partial breast irradiation
Time frame: 1 month after RT & Q3mos for one year
Determination of which patients are best suited for each individual technique of partial breast irradiation
Time frame: Patients will be followed for a period of five years following completion of radiation.
Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates
Time frame: Ipsilateral breast 6 mos after dx, bilateral annually x 5 years
This study is completed, as verified in Aug 2015. You cannot join it, but the record below documents what was studied.
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Case Comprehensive Cancer Center