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Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Stanford University Identifier:
First received: September 12, 2005
Last updated: December 8, 2016
Last verified: December 2016
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.

Condition Intervention
Breast Cancer
Carcinoma, Ductal
Radiation: Intra-Operative Radiotherapy (IORT)
Procedure: Lumpectomy
Radiation: Whole Breast Radiotherapy
Radiation: Intracavitary Brachytherapy
Radiation: Accelerated External Beam 3-D Conformal Radiotherapy
Radiation: Stereotactic APBI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

Resource links provided by NLM:

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 400
Study Start Date: September 2002
Estimated Study Completion Date: March 2029
Estimated Primary Completion Date: March 2029 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Accelerated Partial Breast Irradiation
lumpectomy with accelerated partial breast irradiation
Radiation: Intra-Operative Radiotherapy (IORT)
single dose in the operating room after lumpectomy
Procedure: Lumpectomy Radiation: Intracavitary Brachytherapy
5 day treatment
Other Name: MammoSite
Radiation: Accelerated External Beam 3-D Conformal Radiotherapy
5 day treatment
Radiation: Stereotactic APBI
4 day treatment
Active Comparator: Standard Therapy
lumpectomy and whole breast irradiation
Procedure: Lumpectomy Radiation: Whole Breast Radiotherapy
six and a half week treatment


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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)
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Please refer to this study by its identifier: NCT00185744

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Principal Investigator: Frederick M. Dirbas Stanford University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Stanford University Identifier: NCT00185744     History of Changes
Other Study ID Numbers: BRSNSTU0003
78466 ( Other Identifier: Old IRB Protocol ID )
BRSNSTU0003 ( Other Identifier: OnCore )
IRB-13807 ( Other Identifier: Stanford IRB )
Study First Received: September 12, 2005
Last Updated: December 8, 2016
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Carcinoma, Ductal
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary processed this record on April 26, 2017