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

• Register: ClinicalTrials.gov
• Last refreshed on: 26 June 2023
• Main ID: NCT01570998
• Date of registration: 02/03/2012
• Prospective Registration: Yes
• Primary sponsor: University of California, San Francisco
• Public title: Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery
• Scientific title: Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery
• Date of first enrolment: May 18, 2012
• Target sample size: 1500
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT01570998
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United States

Contacts

• Name: Michael Alvarado, MD
• Affiliation: University of California, San Francisco

• Name: Catherine Dugan

Key inclusion & exclusion criteria

Inclusion Criteria:

- Suitable for breast conserving surgery

- T1 and T2 (< 3.5 cm), N0, M0

Exclusion Criteria:

- 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



Age minimum: 45 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Stage IA Breast Cancer

Stage IIA Breast Cancer

Intervention(s)

Radiation: Intraoperative Radiation Therapy

Other: Laboratory Biomarker Analysis

Primary Outcome(s)

Median Overall Survival [Time Frame: Up to 5 years]

Incidence of local recurrence [Time Frame: Up to 5 years]

Frequency of site of relapse within the breast [Time Frame: Up to 5 years]

Median Relapse-free survival [Time Frame: Up to 5 years]

Percentage of participants with treatment-related adverse events [Time Frame: Up to 5 years]

Secondary ID(s)

NCI-2017-00461

117515

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Carl Zeiss Meditec AG