Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer

Study Overview
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Brief Summary
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This study is being performed to understand the safety of a new radiation treatment called Multi-Beam Intensity Modulated Radiation Therapy ( IMRT). Currently, the standard way of giving radiation is with simplified IMRT, which uses only 2 beams of radiation. Multi-beam IMRT works by using 6-12 small radiation beams to give a more tailored or customized radiation dose to the breast, chest wall, and the lymph nodes. At the same time, multi-beam IMRT may allow the dose to the heart, lungs, and nearby tissue to be lowered, especially when the internal mammary lymph nodes need to be targeted by radiation.

Official Title
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Pilot Study of Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer Patients Requiring Treatment of the Internal Mammary Lymph Nodes

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: Multi-Beam Intensity-Modulated Radiation Therapy
* Behavioral: BreastQ questionnaire-


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female gender Age ≥18 years An invasive primary breast cancer of any histology arising from breast parenchyma Patient must be status post mastectomy or partial mastectomy with an assessment of axillary nodes via sentinel lymph node biopsy and/or axillary lymph node dissection Pathologic confirmation of metastatic disease in at least one regional lymph node. Regional lymph nodes are defined as the ipsilateral axillary lymph nodes, ipsilateral supraclavicular lymph nodes, and ipsilateral internal mammary lymph nodes. Thus, any T stage is allowed as long as the N stage is ≥1 and M stage is 0. Patient signed study-specific consent form. Exclusion Criteria: Patients with distant metastasis. Patients who are pregnant or breastfeeding. Patients with psychiatric or addictive disorders that would preclude obtaining informed consent. Time between initial diagnosis of breast cancer and start of radiation therapy exceeds 13 months. Estimated life expectancy judged to be less than one year by patient's treating radiation oncologist. Prior radiation therapy to the ipsilateral or contralateral breast or thorax. Primary breast cancer is a lymphoma or sarcoma histology. Patients with a history of non-skin malignancy <5 years prior to the diagnosis of breast cancer. Patients requiring radiation to the bilateral breasts.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: radiation therapy via multi-beam IMRT<br>This is a single-arm feasibility study of multi-beam IMRT with daily set-up verification in the treatment of women with node-positive breast cancer who will receive radiation to the breast/chest wall and regional lymph nodes, including the internal mammary lymph nodes. | Radiation: Multi-Beam Intensity-Modulated Radiation Therapy<br>* IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.<br>Behavioral: BreastQ questionnaire-<br>* MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification | The purpose of this pilot study is to assess the feasibility of utilizing multi-beam IMRT in the adjuvant treatment of the breast and regional lymph nodes of women with node-positive breast cancer requiring coverage of the internal mammary lymph nodes. A feasibility rate of at least 90% is required, ie, treatment can be successfully planned and delivered for at least 90% of the patients. | 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Evaluated for Acute and Late Cutaneous Toxicity | Toxicity evaluated by utilizing the CTCAE version 3.0 grading system. | 5-7 months following the completion of radiation therapy | 
| Number of Participants Evaluated for Late Subcutaneous Fibrosis | The radiation oncologist will score late subcutaneous fibrosis at 5-7 months following CoT, utilizing the CTCAE version 3.0 grading system. | 5-7 months following the completion of radiation therapy | 
| Mean FEV1 at Baseline | Participants FEV1 (forced expiratory volume in 1 second) measured at baseline | Baseline | 
| Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%) | Severity of radiation pneumonitis (RP) measured by FEV1 Z (forced expiratory volume in 1 second) and FVC Z (forced vital capacity) for participants at baseline | Baseline | 
| Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg) | Participant Pulmonary Function Test/PFTs and mean Community-Acquired Pneumonia/CAP scores will be taken at baseline and again at 6 months post radiation therapy | Baseline | 
| Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score | Mean Community-Acquired Pneumonia/CAP scores will be taken at baseline and again at 6 months post radiation therapy. The questionnaire focuses on the presence of dyspnea, severity of dyspnea, presence of cough, and general health and generates a CAP score. Low values indicate more severe symptoms. Means will be taken of total scores, from 1-100. | Baseline | 
| Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%) | Participant Pulmonary Function Test/PFTs and mean Community-Acquired Pneumonia/CAP scores will be taken at baseline and again at 6 months post radiation therapy | 6 months post radiation therapy | 
| Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%) | Severity of radiation pneumonitis (RP) measured by FEV1 Z (forced expiratory volume in 1 second) and FVC Z (forced vital capacity) for participants 6 months from baseline. | 6 months post radiation therapy | 
| Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg) | Participant Pulmonary Function Test/PFTs and mean Community-Acquired Pneumonia/CAP scores will be taken at baseline and again at 6 months post radiation therapy | 6 months post radiation therapy | 
| Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score | Mean Community-Acquired Pneumonia/CAP scores will be taken at 6 months post radiation therapy. The questionnaire focuses on the presence of dyspnea, severity of dyspnea, presence of cough, and general health and generates a CAP score. Low values indicate more severe symptoms. Means will be taken of total scores, from 1-100. | 6 months post radiation therapy | 
| Median Follow-up Period | Median follow-up period of the enrolled cohort | up to 82 months post-radiation therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast, Radiation, Multi-Beam Intensity-Modulated Radiation, post mastectomy, post partial mastectomy, node-positive breast cancer, 10-025