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

• Sponsor: Memorial Sloan Kettering Cancer Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01127373
• Collaborator: (none)
• Enrollment: 116
• Locations: 7
• Arm: 1
• Actual Duration (Months): 112.7
• Patients Per Site: 16.6
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Radiation: Multi-Beam Intensity-Modulated Radiation Therapy; Behavioral: BreastQ questionnaire-	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 116 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Study of Multi-Beam Intensity-Modulated Radiation Therapy for Node-Positive Breast Cancer Patients Requiring Treatment of the Internal Mammary Lymph Nodes
• Actual Study Start Date: May 11, 2010
• Actual Primary Completion Date: Oct 2, 2019
• Actual Study Completion Date: Oct 2, 2019

Arms and Interventions

Arm

Intervention/Treatment

Experimental: radiation therapy via multi-beam IMRT 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; 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.; Behavioral: BreastQ questionnaire-; 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.

Outcome Measures

Primary Outcome Measures

1. Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification [5 weeks]

   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.

Secondary Outcome Measures

1. Number of Participants Evaluated for Acute and Late Cutaneous Toxicity [5-7 months following the completion of radiation therapy]

   Toxicity evaluated by utilizing the CTCAE version 3.0 grading system.

2. Number of Participants Evaluated for Late Subcutaneous Fibrosis [5-7 months following the completion of radiation therapy]

   The radiation oncologist will score late subcutaneous fibrosis at 5-7 months following CoT, utilizing the CTCAE version 3.0 grading system.

3. Mean FEV1 at Baseline [Baseline]

   Participants FEV1 (forced expiratory volume in 1 second) measured at baseline

4. Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%) [Baseline]

   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

5. Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg) [Baseline]

   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. Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score [Baseline]

   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.

7. Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%) [6 months post radiation therapy]

   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

8. Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%) [6 months post radiation therapy]

   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.

9. Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg) [6 months post radiation therapy]

   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

10. Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score [6 months post radiation therapy]

    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.

11. Median Follow-up Period [up to 82 months post-radiation therapy]

    Median follow-up period of the enrolled cohort

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memorial Sloan Kettering Basking Ridge (Follow Up Only)	Basking Ridge	New Jersey	United States	07920
2	Memoral Sloan Kettering Monmouth (Follow Up Only)	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Commack (Follow Up Only)	Commack	New York	United States	11725
4	Memorial Sloan Kettering Westchester (Follow Up Only)	Harrison	New York	United States	10604
5	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
6	Memorial Sloan Kettering Rockville Centre (Follow Up Only)	Rockville Centre	New York	United States
7	Memorial Sloan Kettering Nassau (Follow Up Only)	Uniondale	New York	United States	11553

Sponsors and Collaborators

• Memorial Sloan Kettering Cancer Center

Investigators

• Principal Investigator: Simon Powell, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 11, 2019

More Information

Additional Information:

• Memorial Sloan-Kettering Cancer Center

Publications

None provided.

• Responsible Party: Memorial Sloan Kettering Cancer Center
• ClinicalTrials.gov Identifier: NCT01127373
• Other Study ID Numbers: 10-025
• First Posted: May 20, 2010
• Last Update Posted: Apr 20, 2021
• Last Verified: Oct 1, 2019

• Keywords provided by Memorial Sloan Kettering Cancer Center: Breast; Radiation; Multi-Beam Intensity-Modulated Radiation; post mastectomy; post partial mastectomy; node-positive breast cancer; 10-025
• Additional relevant MeSH terms: Breast Neoplasms

Study Results

Participant Flow

Arm/Group Title	Radiation Therapy Via Multi-beam IMRT
Arm/Group Description	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. Multi-Beam Intensity-Modulated Radiation Therapy: 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. BreastQ questionnaire-: 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.
Period Title: Overall Study
STARTED	116
COMPLETED	104
NOT COMPLETED	12

Baseline Characteristics

Arm/Group Title	Radiation Therapy Via Multi-beam IMRT
Arm/Group Description	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. Multi-Beam Intensity-Modulated Radiation Therapy: 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. BreastQ questionnaire-: 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.
Overall Participants	116
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	50
Sex: Female, Male (Count of Participants)
Female	115 99.1%
Male	1 0.9%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	7 6%
Not Hispanic or Latino	109 94%
Unknown or Not Reported	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	14 12.1%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	15 12.9%
White	79 68.1%
More than one race	0 0%
Unknown or Not Reported	8 6.9%
Region of Enrollment (Count of Participants)
United States	116 100%

Outcome Measures

1. Primary Outcome

Title	Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification
Description	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.
Time Frame	5 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation Therapy Via Multi-beam IMRT
Arm/Group Description	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. Multi-Beam Intensity-Modulated Radiation Therapy: 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. BreastQ questionnaire-: 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.
Measure Participants	116
Discontinued IMRT due to disease progression	1 0.9%
Completed IMRT	111 95.7%
Ineligible	4 3.4%

2. Secondary Outcome

Title	Number of Participants Evaluated for Acute and Late Cutaneous Toxicity
Description	Toxicity evaluated by utilizing the CTCAE version 3.0 grading system.
Time Frame	5-7 months following the completion of radiation therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation Therapy Via Multi-beam IMRT
Arm/Group Description	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. Multi-Beam Intensity-Modulated Radiation Therapy: 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. BreastQ questionnaire-: 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.
Measure Participants	116
Count of Participants [Participants]	116 100%

3. Secondary Outcome

Title	Number of Participants Evaluated for Late Subcutaneous Fibrosis
Description	The radiation oncologist will score late subcutaneous fibrosis at 5-7 months following CoT, utilizing the CTCAE version 3.0 grading system.
Time Frame	5-7 months following the completion of radiation therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation Therapy Via Multi-beam IMRT
Arm/Group Description	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. Multi-Beam Intensity-Modulated Radiation Therapy: 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. BreastQ questionnaire-: 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.
Measure Participants	116
Experienced Skin & subcutaneous tissue disorders	1 0.9%
Did not experience skin & subcutaneous tissue diso	115 99.1%

4. Secondary Outcome

Title	Mean FEV1 at Baseline
Description	Participants FEV1 (forced expiratory volume in 1 second) measured at baseline
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation Therapy Via Multi-beam IMRT
Arm/Group Description	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. Multi-Beam Intensity-Modulated Radiation Therapy: 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. BreastQ questionnaire-: 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.
Measure Participants	116
Mean (Full Range) [liters]	2.6

5. Secondary Outcome

Title	Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)
Description	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
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation Therapy Via Multi-beam IMRT
Arm/Group Description	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. Multi-Beam Intensity-Modulated Radiation Therapy: 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. BreastQ questionnaire-: 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.
Measure Participants	116
Mean (Full Range) [FEV1 / FVC percentage]	80.1

6. Secondary Outcome

Title	Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg)
Description	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
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation Therapy Via Multi-beam IMRT
Arm/Group Description	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. Multi-Beam Intensity-Modulated Radiation Therapy: 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. BreastQ questionnaire-: 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.
Measure Participants	116
Mean (Full Range) [mL/min/mmHg]	18.5

7. Secondary Outcome

Title	Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score
Description	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.
Time Frame	Baseline

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation Therapy Via Multi-beam IMRT
Arm/Group Description	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. Multi-Beam Intensity-Modulated Radiation Therapy: 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. BreastQ questionnaire-: 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.
Measure Participants	116
Mean (Full Range) [units on a scale]	84.8

8. Secondary Outcome

Title	Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)
Description	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
Time Frame	6 months post radiation therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation Therapy Via Multi-beam IMRT
Arm/Group Description	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. Multi-Beam Intensity-Modulated Radiation Therapy: 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. BreastQ questionnaire-: 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.
Measure Participants	116
Mean (Full Range) [1 sec/FEV1 (Liters)]	2.6

9. Secondary Outcome

Title	Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)
Description	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.
Time Frame	6 months post radiation therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation Therapy Via Multi-beam IMRT
Arm/Group Description	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. Multi-Beam Intensity-Modulated Radiation Therapy: 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. BreastQ questionnaire-: 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.
Measure Participants	116
Mean (Full Range) [FEV1 / FVC percentage]	79.6

10. Secondary Outcome

Title	Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg)
Description	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
Time Frame	6 months post radiation therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation Therapy Via Multi-beam IMRT
Arm/Group Description	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. Multi-Beam Intensity-Modulated Radiation Therapy: 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. BreastQ questionnaire-: 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.
Measure Participants	116
Mean (Full Range) [mL/min/mmHg]	18.8

11. Secondary Outcome

Title	Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score
Description	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.
Time Frame	6 months post radiation therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation Therapy Via Multi-beam IMRT
Arm/Group Description	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. Multi-Beam Intensity-Modulated Radiation Therapy: 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. BreastQ questionnaire-: 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.
Measure Participants	116
Mean (Full Range) [units on a scale]	83.2

12. Secondary Outcome

Title	Median Follow-up Period
Description	Median follow-up period of the enrolled cohort
Time Frame	up to 82 months post-radiation therapy

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Radiation Therapy Via Multi-beam IMRT
Arm/Group Description	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. Multi-Beam Intensity-Modulated Radiation Therapy: 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. BreastQ questionnaire-: 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.
Measure Participants	116
Median (Full Range) [months]	53.4

Adverse Events

Time Frame	5-7 months following the completion of radiation therapy, up to 82 months
Arm/Group Title	Radiation Therapy Via Multi-beam IMRT
Arm/Group Description	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. Multi-Beam Intensity-Modulated Radiation Therapy: 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. BreastQ questionnaire-: 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.
All Cause Mortality
	Radiation Therapy Via Multi-beam IMRT
	Affected / at Risk (%)	# Events
Total	33/116 (28.4%)
Serious Adverse Events
	Radiation Therapy Via Multi-beam IMRT
	Affected / at Risk (%)	# Events
Total	10/116 (8.6%)
General disorders
Death not assoc w CTCAE term-Disease prog NOS	1/116 (0.9%)
Fever (in the absence of neutropenia)	1/116 (0.9%)
Pain - Chest/thorax NOS	1/116 (0.9%)
Infections and infestations
Breast Infection	1/116 (0.9%)
Musculoskeletal and connective tissue disorders
Back Pain	1/116 (0.9%)
Muscle weakness - Whole body/general	1/116 (0.9%)
Pain - Back	1/116 (0.9%)
Nervous system disorders
Dysarthria	1/116 (0.9%)
Nervous system disorders - Other, specify	1/116 (0.9%)
Seizure	2/116 (1.7%)
Respiratory, thoracic and mediastinal disorders
Dyspnea	2/116 (1.7%)
Productive cough	1/116 (0.9%)
Wheezing	1/116 (0.9%)
Skin and subcutaneous tissue disorders
Inf norm ANC/gr1/2 neut-Cellulitis(skin)	2/116 (1.7%)
Rash: erythema multiforme	1/116 (0.9%)
Skin & subcutaneous tissue disorders Other, spec	1/116 (0.9%)
Vascular disorders
Thrombosis/thrombus/embolism	1/116 (0.9%)
Other (Not Including Serious) Adverse Events
	Radiation Therapy Via Multi-beam IMRT
	Affected / at Risk (%)	# Events
Total	3/116 (2.6%)
Respiratory, thoracic and mediastinal disorders
Cough	1/116 (0.9%)
Skin and subcutaneous tissue disorders
Pruritis	1/116 (0.9%)
Rash: dermatitis assoc w/ rad-	1/116 (0.9%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.