Breast Cancer Clinical Trial
Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
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.
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:
Men
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)
Greater than 12 weeks since definitive surgical excision or completion of chemotherapy
Involved lymph nodes detected by frozen section or touch preparation at time of lumpectomy
Patients with 1 to 3 positive lymph nodes determined postoperatively (does not include patients with micro-metastases)
Subglandular or submuscular breast implants (does not include patients having implants placed AFTER intra-operative radiotherapy)
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There is 1 Location for this study
Stanford California, 94305, United States
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