This trial is active, not recruiting.

Conditions breast cancer, carcinoma, ductal
Treatments intra-operative radiotherapy (iort), lumpectomy, whole breast radiotherapy, intracavitary brachytherapy, accelerated external beam 3-d conformal radiotherapy, stereotactic apbi
Sponsor Stanford University
Start date September 2002
End date March 2029
Trial size 400 participants
Trial identifier NCT00185744, 78466, BRSNSTU0003, IRB-13807


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
lumpectomy with accelerated partial breast irradiation
intra-operative radiotherapy (iort)
single dose in the operating room after lumpectomy
intracavitary brachytherapy MammoSite
5 day treatment
accelerated external beam 3-d conformal radiotherapy
5 day treatment
stereotactic apbi
4 day treatment
(Active Comparator)
lumpectomy and whole breast irradiation
whole breast radiotherapy
six and a half week treatment

Primary Outcomes

In-breast tumor recurrence (IBTR)
time frame: 20 years

Eligibility Criteria

Female participants at least 40 years old.

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)

Additional Information

Official title Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
Principal investigator Frederick M. Dirbas
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by Stanford University.