This study proposes to study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single dose after breast conserving surgery, with or without whole breast radiation as indicated by pathologic risk factors, in women with early stage breast cancer.
Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery
A pragmatic registry trial has been designed and modeled after the original successful, international TARGIT-A protocol, to continue the use of intraoperative radiotherapy for a select population of women, and to follow outcomes with regards to local and regional control, toxicity and morbidity. Within this pragmatic single arm registry trial is a more selective approach that may be employed in some centers for some or all patients. Patients selected for breast conserving surgery who are considered to have a low risk of local recurrence are eligible for the registry trial once given their informed consent.
Malignant Neoplasm of BreastBreast DiseasesDuctal Breast CarcinomaDisease-Free SurvivalFemaleHumansIntraoperative CareMastectomy SegmentalMiddle AgedNeoplasm Recurrence LocalRadiotherapy DosageRadiotherapy Adjuvant
You can join if…
Open to females ages 45 years and up
All patients aged 45 years or older with operable invasive breast cancer, T1 and T2(< 3.5 cm), N0-1, 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. 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.
You CAN'T join if...
Age < 45 years
Axillary lymph node positive breast cancer
Invasive lobular cancer
Tumor size> 3.5 cm
Extensive Intraductal Component (EIC=> 25% of the lumpectomy specimen involved with ductal carcinoma in situ, DCIS) as assessed on surgical pathologic lumpectomy specimen
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.
Inability to assess pathologic margin status
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 intent of reducing tumor size.
No more than 30 days can have elapsed between the last breast cancer surgery (not axillary) and entry into the trial for patients in the post-pathology stratification.
Previous history of malignant disease does not preclude entry if the expectation of relapse-free survival at 10 years is 75% or greater
Any factor included as exclusion criteria in the participating center's Treatment Policy Statement.
UCSF Carol Franc Buck Breast Care Centeraccepting new patients San Francisco, California, 94115, USA
Alta Bates Summit Medical Centernot yet accepting patients Berkeley, California, 94609, USA
John Muir Medical Centeraccepting new patients Walnut Creek, California, 94598, USA
Los Angeles Women's Health Clinic of California Hospital Medical Centeraccepting new patients Los Angeles, California, 90015, USA
University of California, Irvineaccepting new patients Orange, California, 92868, USA