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Title Phase IV: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery

IRB TARGIT-US

CC 14-599

Hospital Main Campus

Phase Phase 4

Disease Breast

Description

To study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery, with or without whole breast radiation as indicated by pathologic risk factors, in women with early stage breast cancer.

• In-breast local failure and patterns of in-breast failure
• Ipsilateral regional nodal failure
• Toxicity and morbidity
• Relapse-free survival
• Overall survival

Inclusion Criteria

• All female patients aged 45 years or older with operable invasive breast cancer, T1 and T2 (< 3.5 cm), N0, M0, confirmed by cytological or histological examination, who are suitable for breast conserving surgery are eligible as long as they have had an ipsilateral diagnostic mammogram within 12 months of enrollment. Those with previously diagnosed and treated contralateral breast cancer may be entered. It is recommended that patients meet an ECOG performance status of 0-3, however, grade 4 patients can be treated at the discretion of the participating center.
• Individual centers may wish to restrict entry to a more exactly defined subset of patients in which case only patients with these characteristics may be entered by the particular center. For example, centers may decide at outset to recruit only women over the age of 50 or possibly only postmenopausal women. Such policies must be predefined in writing on the Treatment Policy Statement form, submitted and approved by the Steering Committee, and followed for all patients enrolled at that center. See section 6.1.
• Before entering any patient into the trial, the local investigator should confirm that the patient would be available for regular follow-up for at least 5 years.

Exclusion Criteria

1. Age < 45 years
2. Axillary lymph node positive breast cancer
3. Invasive lobular cancer
4. Tumor size > 3.5 cm
5. Extensive Intraductal Component (EIC ≥ 25% of the lumpectomy specimen involved with ductal carcinoma in situ, DCIS) as assessed on surgical pathologic lumpectomy specimen
6. Multicentric cancer in the same breast as diagnosed by clinical examination, mammography, ultrasound. MRI or pathologic assessment, not amenable to excision with negative margins with a single lumpectomy.
7. Inability to assess pathologic margin status
8. Synchronous bilateral breast cancer at the time of diagnosis.
9. Ipsilateral breast had a previous cancer and/or prior in-field radiation.
10. Patients known to have BRCA1/2 gene mutations (testing for gene mutations is not required).
11. Patients undergoing primary systemic treatment (hormones or chemotherapy) as initial treatment with neoadjuvant intent of reducing tumor size.
12. Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 75% or greater
13. Any factor included as exclusion criteria in the participating center's Treatment Policy Statement.