Breast Cancer, Carcinoma, Ductal
Conditions
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.
Interventions
RADIATIONIntra-Operative Radiotherapy (IORT)
single dose in the operating room after lumpectomy
PROCEDURELumpectomy
RADIATIONWhole Breast Radiotherapy
six and a half week treatment
RADIATIONIntracavitary Brachytherapy
5 day treatment
RADIATIONAccelerated External Beam 3-D Conformal Radiotherapy
5 day treatment
RADIATIONStereotactic APBI
4 day treatment
Sponsors
Stanford University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| In-breast tumor recurrence (IBTR) | 20 years | Proportion of subjects that experience in-breast tumor recurrence (IBTR), to be assessed through or by March 2029 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORFrederick M. Dirbas
Stanford University
Outcome results
None listed