Radiation Therapy During Surgery in Treating Older Women With Invasive Breast Cancer

Not Applicable

Completed

Conditions: Breast Cancer

Interventions: Procedure: surgery
Procedure: therapy
Radiation: radiation therapy

Registration Number: NCT00182728

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Brief Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation during surgery may be an effective treatment for breast cancer.

PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for invasive breast cancer.

Detailed Description: OBJECTIVES:

Primary

* Determine the feasibility of intraoperative partial breast radiotherapy prior to surgical resection in older women with low-risk early stage primary invasive ductal carcinoma of the breast. Feasibility will be determined by the rate of good/excellent cosmesis, as measured by the Radiation Therapy Oncology Group (RTOG) cosmetic rating scale, in patients treated with this regimen compared with that of patients treated with partial breast brachytherapy in clinical trial RTOG-9517.

* Determine the incidence of grade 3-4 toxicity of this regimen in these patients.

* Determine the rate of ipsilateral breast recurrence, including recurrence within the tumor bed as compared to elsewhere in the breast, in patients treated with this regimen.

Secondary

* Determine the radiation-induced activation of receptors and signal transduction pathways involved in radiation response in patients treated with this regimen.

OUTLINE: This is a non-randomized study.

Patients undergo intraoperative lymphatic mapping and sentinel lymphadenectomy OR standard level I, II axillary dissection to evaluate the lymph nodes followed by intraoperative breast ultrasonography to define the tumor target volume. Patients then undergo intraoperative single-dose partial breast radiotherapy followed by segmental mastectomy (i.e., lumpectomy) of the tumor. Patients with 1 or 2 tumor-involved surgical margins may undergo repeat segmental mastectomy. Patients with \> 2 tumor-involved surgical margins undergo mastectomy. Patients determined to have a tumor size \> 3 cm or an extensive intraductal component on final pathology evaluation undergo standard external beam radiotherapy after surgery.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 2 to 3 years.

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 89

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraoperative Radiation Arm	therapy	Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
Intraoperative Radiation Arm	radiation therapy	Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.
Intraoperative Radiation Arm	surgery	Intraoperative radiotherapy (radiation therapy) during surgery for tumor excision.

Primary Outcome Measures

Name	Time	Method
Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Physician	1 year follow up visit	Rates of good/excellent cosmesis was evaluated using the following criteria: Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance. Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape.
Ipsilateral Breast Recurrence	5 years	Percentage of participants who experienced a ipsilateral breast event (tumor bed recurrence versus elsewhere in breast).
Rates of Good/Excellent Cosmesis as Measured by the Radiation Therapy Oncology Group (RTOG) Cosmetic Rating Scale - Rated by Patients	1 year follow up visit	Rates of good/excellent cosmesis was evaluated using the following criteria: Excellent - when compared to the untreated breast, there is minimal or no difference in the size, shape, or texture of the treated breast. There may be mild thickening or scar tissue within the breast or skin, but not enough to change the appearance. Good - there is mild asymmetry in the size or shape of the treated breast as compared to the normal breast. The thickening or scar tissue within the breast causes only a mild change in the shape.
Incidence of Grade 3/4 Toxicity	3 months	Skin and subcutaneous toxicity were graded by a radiation oncologist according to the common terminology criteria for adverse events version 3.0. Toxicities directly, probably, or possibly related to the radiation were included. Grade refers to the severity of the AE. The CTCAE v3.0 displays Grades 1 through 5 with unique clinical descriptions of severity for each adverse event (AE) based on this general guideline: Grade 1 Mild Adverse Event Grade 2 Moderate Adverse Event Grade 3 Severe Adverse Event Grade 4 Life-threatening or disabling Adverse Event Grade 5 Death related to Adverse Event

Secondary Outcome Measures

Name	Time	Method
Association of Phosphorylated Epidermal Growth Factor Receptor (EGFR) , Human Epidermal Growth Factor Receptor 2 (HER2), p44/42 Mitogen-activated Protein Kinase (MAPK), and Protein Kinase B (Akt) in Breast Tumors and Normal Tissue Before and After IORT	3 months
Association of Nuclear p53 Expression in Tumor and Normal Tissue Before and After IORT	3 months
Association of Nuclear Factor Kappa-light-chain-enhancer of Activated B Cells (NFkB) Expression in Tumor and Normal Tissue Before and After IORT	3 months