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Eligibility
for females ages 45 years and up
Location
at San Francisco, California and other locations
Dates
study started
Principal Investigator

Description

Summary

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.

Official Title

Targeted Intraoperative Radiotherapy United States (TARGIT-US) Phase IV Registry Trial: A Registry Trial of Targeted Intraoperative Radiation Therapy Following Breast-conserving Surgery

Details

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.

Keywords

Malignant Neoplasm of Breast Breast Diseases Ductal Breast Carcinoma Disease-Free Survival Female Humans Intraoperative Care Mastectomy Segmental Middle Aged Neoplasm Recurrence Local Radiotherapy Dosage Radiotherapy Adjuvant

Eligibility

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.

Locations

  • Alta Bates Summit Medical Center not yet accepting patients
    Berkeley, California, 94609, USA
  • John Muir Medical Center accepting new patients
    Walnut Creek, California, 94598, USA
  • Los Angeles Women's Health Clinic of California Hospital Medical Center accepting new patients
    Los Angeles, California, 90015, USA
  • University of California, Irvine accepting new patients
    Orange, California, 92868, USA

Details

Status
accepting new patients
Start Date
Sponsor
University of California, San Francisco
ID
NCT01570998
Phase
Phase 4
Lead Scientist
Michael Alvarado
Study Type
Interventional
Last Updated
December 2016
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