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Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

40 Years
Open (Enrolling)
Breast Cancer, Carcinoma, Ductal

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Trial Information

Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

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

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

13. Involved lymph nodes detected by frozen section or touch preparation at time of

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)

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determination of whether accelerated radiotherapy or stereotactic APBI is a feasible and safe alternative to whole breast radiotherapy.

Principal Investigator

Frederick M. Dirbas

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University


United States: Food and Drug Administration

Study ID:




Start Date:

September 2002

Completion Date:

December 2015

Related Keywords:

  • Breast Cancer
  • Carcinoma, Ductal
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma, Ductal



Stanford University School of Medicine Stanford, California  94305-5317