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Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00185744
Recruitment Status : Active, not recruiting
First Posted : September 16, 2005
Last Update Posted : August 24, 2020
Information provided by (Responsible Party):
Stanford University

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.

Condition or disease Intervention/treatment Phase
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 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer
Study Start Date : September 2002
Estimated Primary Completion Date : March 2029
Estimated Study Completion Date : March 2029

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00185744

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United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
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Principal Investigator: Frederick M. Dirbas Stanford University
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Stanford University Identifier: NCT00185744    
Other Study ID Numbers: IRB-13807
78466 ( Other Identifier: Old IRB Protocol ID )
BRSNSTU0003 ( Other Identifier: OnCore )
IRB-13807 ( Other Identifier: Stanford IRB )
First Posted: September 16, 2005    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Carcinoma, Ductal
Neoplasms by Site
Breast Diseases
Skin Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary