Breast Cancer
Conditions
Keywords
breast cancer, IORT, brachytherapy
Brief summary
This is a physician sponsored multi-center, non-randomized, prospectively enrolling data collection study of patients with early stage breast cancer treated with electronic brachytherapy at the time of surgical resection of the cancer in the operating room. The radiation therapy treatments will be administered with electronic brachytherapy using the FDA cleared Xoft Axxent System.
Detailed description
Breast Conserving Therapy (BCT) is a standard treatment option for patients with stage I or II breast cancer. Breast conserving therapy consists of surgical removal of the tumor with negative margins, axillary lymph node dissection or sentinel node biopsy and radiation therapy. Several studies have shown BCT to be comparable to mastectomy in terms of overall and disease free survival for patients. The major advantage to BCT over mastectomy is breast preservation and reduced psychological trauma to the patient. The major disadvantage to BCT is prolonged time of treatment. The whole breast radiation portion of BCT can add 7 weeks to the treatment time. This additional treatment time can be a detriment to women who logistically may not be able to meet the demands of daily irradiation for 6-7 weeks. A new form of treatment, breast brachytherapy, was developed to decrease the treatment time required for breast irradiation. This treatment uses the Xoft Axxent system to administer intra-operative breast brachytherapy in one treatment, at the time of lumpectomy in the operating room. This study has been designed to assess local recurrence, serious adverse events, adverse events and their severity, and cosmesis following intra-operative radiation therapy (IORT) using the Xoft Axxent System and balloon applicators. The study device is FDA cleared. The purpose of this clinical study is to compile data on the treatment of patients using the Xoft Axxent System for the delivery of radiation therapy in the intra-operative setting as part of breast conserving therapy in women with resected, early stage breast cancer.
Interventions
All subjects will receive IORT at the time of lumpectomy.
Sponsors
Xoft, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria 1. Age \> 45 years 2. Tumor with Tis, T1, T2 (≤ 3cm), N0, M0 - (AJC Classification) 3. Invasive ductal carcinoma and / or DCIS Intra-operative Inclusion Criteria 1. Negative sentinel node assessment 2. Balloon surface to skin distance of at least 1-cm and adequate conformance via Intra-operative ultrasound Post procedure Inclusion Criteria 1. Negative microscopic surgical margins\*\* \*\*If positive margins patient my undergo re-excision and/or additional radiation at the treating physician's discretion but the patient will be excluded from the protocol data analysis. General
Exclusion criteria
1. Scleroderma, systemic sclerosis and active lupus 2. Participation in an investigational drug or device study 3. Previous ipsilateral radiation to the thorax or breast Intra-operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Local recurrence in patients treated with intra-operative electronic brachytherapy for early stage breast cancer. | 5 Years | Local recurrence will be assessed at one (1) month, six (6) months, one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years post IORT. |
| Occurence of serious adverse events during and following IORT treatment. | 5 Years | Serious adverse events are defined as a serious injury or illness that: 1. is life threatening, even if temporary in nature; 2. results in permanent impairment of a body function or permanent damage to a body structure; or 3. necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmesis | 5 Years | Cosmesis will be evaluated with the Harvard scale at one (1) month, six (6) months, and at one (1) year, two (2) years, three (3) years, four (4) years, and five (5) years post IORT. |
Countries
United States
Outcome results
None listed