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Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

Not Recruiting

Trial ID: NCT00185744

Age - 40 Years-N/A Condition - Breast Cancer Gender - Female Accepting Healthy Volunteers - No

Purpose

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.

Official Title

Accelerated Partial Breast Irradiation Following Lumpectomy for Breast Cancer

Stanford Investigator(s)

Frederick M. Dirbas, MD
Frederick M. Dirbas, MD

Associate Professor of Surgery (General Surgery)

Kathleen Horst, MD
Kathleen Horst, MD

Professor of Radiation Oncology (Radiation Therapy)

Richard Sibley
Richard Sibley

Professor of Pathology, Emeritus

Bruce Daniel
Bruce Daniel

Professor of Radiology (Body Imaging) and, by courtesy, of Bioengineering

Debra M. Ikeda, M.D.
Debra M. Ikeda, M.D.

Professor of Radiology (Breast Imaging), Emerita

Eligibility


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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Intervention(s):

procedure: Lumpectomy

radiation: Intra-Operative Radiotherapy (IORT)

radiation: Whole Breast Radiotherapy

radiation: Intracavitary Brachytherapy

radiation: Accelerated External Beam 3-D Conformal Radiotherapy

radiation: Stereotactic APBI

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Sally Bobo
6507361472

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