Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

N/AActive Not RecruitingNCT00185744

Stanford University121 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

121

Conditions

Breast Cancer Carcinoma, Ductal

Interventions

Eligibility

Sex: FEMALEMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Women \>= 40 with invasive ductal carcinoma or ductal carcinoma in situ 2. Patient chooses lumpectomy rather than mastectomy as treatment for breast cancer 3. Tumor \< 2.5 cm in size, 2 mm margin of normal breast tissue between cancer and edge of specimen. Exclusion Criteria: 1. Men 2. Prior malignancy, breast or other if metastatic or with anticipated survival of \< 5 years 3. Pregnant women 4. Immunocompromised 5. Poorly controlled insulin dependent diabetes 6. Contraindication to radiotherapy, e.g. connective tissue disorder such as scleroderma 7. Breast cancer that involves skin or chest wall 8. Multifocal or Multicentric breast cancer 9. Invasive lobular carcinoma 10. Diffuse microcalcifications on mammography 11. Invasive carcinoma with extensive intraductal component (EIC) 12. Greater than 12 weeks since definitive surgical excision or completion of chemotherapy 13. Involved lymph nodes detected by frozen section or touch preparation at time of lumpectomy 14. Patients with 1 to 3 positive lymph nodes determined postoperatively (does not include patients with micro-metastases) 15. Subglandular or submuscular breast implants (does not include patients having implants placed AFTER intra-operative radiotherapy)

Outcomes

Primary Outcomes

In-breast tumor recurrence (IBTR)

Proportion of subjects that experience in-breast tumor recurrence (IBTR), to be assessed through or by March 2029

Time frame: 20 years