Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Stanford University
- Enrollment
- 121
- Locations
- 1
- Primary Endpoint
- In-breast tumor recurrence (IBTR)
- Status
- Active, not recruiting
- Last Updated
- last month
Overview
Brief Summary
To determine whether an accelerated course of radiotherapy delivered to the lumpectomy cavity plus margin using IORT as a single dose, intracavitary brachytherapy with the MammoSite device over 5 days, partial breast 3-D CRT in 5 days, or stereotactic APBI over 4 days is a feasible and safe alternative to a six and a half week course of whole breast radiotherapy. The study will measure both short and long-term complications of radiation treatment, short and long-term breast cosmesis, local rates of in-breast cancer recurrence, regional recurrences, distant metastases, and overall survival.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Women \>= 40 with invasive ductal carcinoma or ductal carcinoma in situ
- •Patient chooses lumpectomy rather than mastectomy as treatment for breast cancer
- •Tumor \< 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen.
Exclusion Criteria
- •Prior malignancy, breast or other if metastatic or with anticipated survival of \< 5 years
- •Pregnant women
- •Immunocompromised
- •Poorly controlled insulin dependent diabetes
- •Contraindication to radiotherapy, e.g. connective tissue disorder such as scleroderma
- •Breast cancer that involves skin or chest wall
- •Multifocal or Multicentric breast cancer
- •Invasive lobular carcinoma
- •Diffuse microcalcifications on mammography
- •Invasive carcinoma with extensive intraductal component (EIC)
Outcomes
Primary Outcomes
In-breast tumor recurrence (IBTR)
Time Frame: 20 years
Proportion of subjects that experience in-breast tumor recurrence (IBTR), to be assessed through or by March 2029