Clinical trial · Interventional
Intraoperative Radiation Therapy in Treating Patients With Breast Cancer Undergoing Breast-Conserving Surgery
Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Stage IA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intraoperative Radiation Therapy | Radiation | — | UNRESOLVED |
| Laboratory Biomarker Analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (IORT)
- description
- Patients undergo IORT in a single fraction over 15-40 minutes at the time of standard of care lumpectomy.
- interventionNames
- Radiation: Intraoperative Radiation Therapy
- Other: Laboratory Biomarker Analysis
Primary outcomes (5)
- measure
- Incidence of local recurrence
- timeFrame
- Up to 5 years
- description
- Local tumor control is defined as no recurrent tumor in the ipsilateral breast. Patients will be regularly monitored as per the individual center's policy provided this meets the minimum trial criteria for follow-up with physical examination at least every 6 months for 3 years and yearly at 4 and 5 years post-treatment. Confirmation of recurrence will follow clinical examination and cytology or biopsy. The two patient cohorts will not be separated for the analysis regarding local control.
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 45 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available