Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery

Running, not enrolling · Not applicable

Conditions studied: Stage IA Breast Cancer, Stage IIA Breast Cancer

In brief

This phase IV trial studies the side effects of intraoperative radiation therapy and how well it works in treating patients with breast cancer undergoing breast-conserving surgery. Delivering radiation one time to the area where the tumor was removed while the patient is still in the operating room may kill any residual tumor cells and may be as effective as standard radiation therapy in patients with early stage breast cancer.

Key facts

Study ID

NCT01570998

Run by

University of California, San Francisco

People needed

1259

Starts

2012-05-18

Expected to finish

2028-12-31

Last updated by the study team

2026-03-18

Who can join

Age: 45 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Suitable for breast conserving surgery
• T1 and T2 (< 3.5 cm), N0, M0

You may not qualify if…

• Axillary lymph node positive breast cancer
• Tumor size > 3.5 cm
• Extensive intraductal component (EIC >= 25% of the lumpectomy specimen involved with ductal carcinoma in situ), as assessed on surgical pathologic lumpectomy specimen
• Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound; magnetic resonance imaging (MRI) or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy
• Inability to assess pathologic margin status
• Synchronous bilateral breast cancer at the time of diagnosis
• Ipsilateral breast had a previous cancer and/or prior in-field radiation
• Patients known to have BRCA1/2 gene mutations (testing for gene mutations is not required)
• Patients undergoing primary systemic treatment (hormones or chemotherapy) as initial treatment with neoadjuvant reducing tumor size
• Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years or greater
• Any factor included as exclusion criteria in the participating center's treatment policy statement
• Additional exclusion criteria for University of California San Francisco (UCSF) (as laid out in the Treatment Policy):
• Patients under the age of 50
• Estrogen receptor negative (as defined in Treatment Policy under "Pathology")
• Human epidermal growth factor receptor 2 (HER2) positive (as defined in Treatment Policy under "HER2")
• Lymphovascular invasion
• High grade
• Tumors > 3 cm
• Node positive patients
• Prior chemotherapy or hormone therapy

Where it is running

• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• University of California, Irvine — Irvine, California, United States
• Dignity Health - California Hospital Medical Center — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• John Muir Medical Center-Walnut Creek — Walnut Creek, California, United States
• Greenwich Hospital — Greenwich, Connecticut, United States
• MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
• MedStar Washington Hospital Center — Washington D.C., District of Columbia, United States
• Cleveland Clinic — Fort Lauderdale, Florida, United States
• Holy Cross Hospital — Fort Lauderdale, Florida, United States
• Memorial Health University Medical Center — Savannah, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• Loyola University Medical Center — Maywood, Illinois, United States
• Community Cancer Center South — Indianapolis, Indiana, United States
• Mercy Medical Center — Baltimore, Maryland, United States
• Lahey Hospital and Medical Center — Burlington, Massachusetts, United States
• Marie Yeager Cancer Center, Spectrum Health Lakeland — Saint Joseph, Michigan, United States
• Community Hospital at Dobbs Ferry — Dobbs Ferry, New York, United States
• Cornell University — Ithaca, New York, United States
• Columbia University/Herbert Irving Cancer Center — New York, New York, United States
• Vassar Brothers Medical Center — Poughkeepsie, New York, United States
• Saint Luke's Hospital-Anderson Campus — Easton, Pennsylvania, United States
• Inova Fairfax Hospital Cancer Center — Fairfax, Virginia, United States
• Sentara Port Warwick — Newport News, Virginia, United States
• Aurora BayCare Medical Center — Green Bay, Wisconsin, United States

Full record on ClinicalTrials.gov

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