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Clinical Trial VICCBRE1298

Title

A Safety and Efficacy Study of Intra-Operative Radiation Therapy (IORT) Using the Xoft? Axxent? eBx System at the Time of Breast Conservation Surgery for Early Stage Breast Cancer

Principal Investigator(s)

Bapsi Chak

Details

  • Protocol No. VICCBRE1298
  • Open Date: 04/19/2013
  • Staging: N/A
  • Age Group: Adults
  • Scope: National
  • Objective: To assess the rate of ipsilateral breast tumor recurrence in subjects treated with the Xoft Axxent Electronic Brachytherapy System when used for single-fraction, intra-operative radiation therapy treatment of early stage breast cancer when compared to a historical control of whole breast irradiation (WBI) at 5 and 10 years of follow-up.
  • Disease Sites: Breast
  • Therapies: Radiotherapy
  • Drugs: None Specified
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01644669
  • Secondary Protocol No: CTPR-0009

Description

The purpose of this study is to compare the effects, good and/or bad, of giving a new form of radiation therapy, called Intra-Operative Radiation Therapy (IORT), after breast conservation surgery (Lumpectomy) for early-stage breast cancer.

Eligibility

Ages Eligible for Study:40 Years and older
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No

Criteria

Inclusion Criteria:
1. Subject must have provided written Informed Consent
2. Subject must have biopsy-proven invasive ductal carcinoma or ductal carcinoma in situ of the breast
3. Subject must be female ≥ 40 years of age
4. Subject's tumor(s) must be < 3.0 cm in greatest diameter by pre-operative assessment
5. Subject's tumor(s) must meet AJCC Tumor Classification: Tis, T1 or T2 (< 3 cm), N0, M0
6. Subject presenting with bilateral breast cancer may be enrolled if BOTH cancers meet all of the inclusion and none of the exclusion criteria
7. Women of child-bearing potential must have a negative pregnancy test within one week of IORT treatment
8. Women of child-bearing potential must agree to use adequate contraceptive precautions (defined as oral contraceptives, intrauterine devices, surgical contraceptives or a combination of condom and spermicide) from the time of negative pregnancy test through completion of the radiation treatment period
Exclusion Criteria:
1. Subject is pregnant or nursing
2. Subject has significant auto-immune disease
3. Subject has a pacemaker present in the field of radiation or quadrant of the breast cancer
4. Subject has biopsy-proven multifocal breast cancer
5. Subject has multi-centric breast cancer
6. Subject has known lympho-vascular invasion
7. Subject has invasive lobular cancer
8. Subject has undergone neo-adjuvant chemotherapy or neo-adjuvant endocrine therapy for current breast cancer
9. Subject has a history of recurrent breast cancer in the ipsilateral breast
10. Subject has had previous radiation exposure of the involved breast
11. Subject has BRCA 1 or 2 mutations. Note: Testing will only be required for Subjects presenting with bilateral breast cancer; testing is not required for unilateral cancers
12. Subject has contraindications for radiation
13. Subject considered by the Investigator to be high-risk for breast conservation surgery and/or intra-operative radiation therapy
14. Subject has participated in any other clinical investigation that is likely to confound study results or affect study outcome either at the time of IORT or for 3 months prior to IORT.