CClinicalTrials.gg
Sign In
CompletedNCT01127373Updated Apr 20, 2021Results posted

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

An interventional study of Multi-Beam Intensity-Modulated Radiation Therapy and BreastQ questionnaire- in Breast Cancer, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 7 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-04-20.

Sponsored by Memorial Sloan Kettering Cancer Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
116
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study 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.

02

Conditions studied

  • Breast Cancer

Browse trials for

Keywords

  • Breast
  • Radiation
  • Multi-Beam Intensity-Modulated Radiation
  • post mastectomy
  • post partial mastectomy
  • node-positive breast cancer
  • 10-025
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 116 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,930 studies on the registry; 328 are open to participants now.

Of its 129 completed or terminated interventional studies of FDA-regulated products, 66 (51%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
116 participants (actual)

Study arms

  • 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 · Behavioral: BreastQ questionnaire-

Interventions

  • RadiationMulti-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.

  • BehavioralBreastQ 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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 weeks

Secondary outcomes

  1. Number of Participants Evaluated for Acute and Late Cutaneous Toxicity

    Toxicity evaluated by utilizing the CTCAE version 3.0 grading system.

    Time frame: 5-7 months following the completion of radiation therapy

  2. 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.

    Time frame: 5-7 months following the completion of radiation therapy

  3. Mean FEV1 at Baseline

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

    Time frame: Baseline

  4. 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

    Time frame: Baseline

  5. 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

    Time frame: Baseline

  6. 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.

    Time frame: Baseline

  7. 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

    Time frame: 6 months post radiation therapy

  8. 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.

    Time frame: 6 months post radiation therapy

  9. 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

    Time frame: 6 months post radiation therapy

  10. 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.

    Time frame: 6 months post radiation therapy

  11. Median Follow-up Period

    Median follow-up period of the enrolled cohort

    Time frame: up to 82 months post-radiation therapy

07

Results

Posted Apr 20, 2021

Participant flow

Participant flow — Overall Study
MilestoneRadiation Therapy Via Multi-beam IMRT
Started116
Completed104
Not completed12
Withdrew: Not treated3
Withdrew: Lost to follow-up7
Withdrew: Withdrawal by subject1
Withdrew: Disease progression1

Outcome measures

PrimaryCount 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.

Time frame:
5 weeks
Reported as:
Count of participants · Participants
Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification
ParticipantsRadiation Therapy Via Multi-beam IMRT
Discontinued IMRT due to disease progression1
Completed IMRT111
Ineligible4
SecondaryNumber of Participants Evaluated for Acute and Late Cutaneous Toxicity

Toxicity evaluated by utilizing the CTCAE version 3.0 grading system.

Time frame:
5-7 months following the completion of radiation therapy
Reported as:
Count of participants · Participants
Number of Participants Evaluated for Acute and Late Cutaneous Toxicity
ParticipantsRadiation Therapy Via Multi-beam IMRT
Number of Participants Evaluated for Acute and Late Cutaneous Toxicity116
SecondaryNumber 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.

Time frame:
5-7 months following the completion of radiation therapy
Reported as:
Count of participants · Participants
Number of Participants Evaluated for Late Subcutaneous Fibrosis
ParticipantsRadiation Therapy Via Multi-beam IMRT
Experienced Skin & subcutaneous tissue disorders1
Did not experience skin & subcutaneous tissue diso115
SecondaryMean FEV1 at Baseline

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

Time frame:
Baseline
Reported as:
Mean · liters
Mean FEV1 at Baseline
litersRadiation Therapy Via Multi-beam IMRT
Mean FEV1 at Baseline2.6 (1.2 to 3.9)
SecondarySeverity 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

Time frame:
Baseline
Reported as:
Mean · FEV1 / FVC percentage
Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)
FEV1 / FVC percentageRadiation Therapy Via Multi-beam IMRT
Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)80.1 (57 to 93)
SecondarySeverity 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

Time frame:
Baseline
Reported as:
Mean · mL/min/mmHg
Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg)
mL/min/mmHgRadiation Therapy Via Multi-beam IMRT
Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg)18.5 (10 to 30)
SecondarySeverity 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.

Time frame:
Baseline
Reported as:
Mean · units on a scale
Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score
units on a scaleRadiation Therapy Via Multi-beam IMRT
Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score84.8 (33.8 to 100)
SecondarySeverity 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

Time frame:
6 months post radiation therapy
Reported as:
Mean · 1 sec/FEV1 (Liters)
Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)
1 sec/FEV1 (Liters)Radiation Therapy Via Multi-beam IMRT
Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)2.6 (1.0 to 3.69)
SecondarySeverity 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.

Time frame:
6 months post radiation therapy
Reported as:
Mean · FEV1 / FVC percentage
Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)
FEV1 / FVC percentageRadiation Therapy Via Multi-beam IMRT
Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%)79.6 (64 to 98)
SecondarySeverity 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

Time frame:
6 months post radiation therapy
Reported as:
Mean · mL/min/mmHg
Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg)
mL/min/mmHgRadiation Therapy Via Multi-beam IMRT
Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg)18.8 (5 to 65)
SecondarySeverity 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.

Time frame:
6 months post radiation therapy
Reported as:
Mean · units on a scale
Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score
units on a scaleRadiation Therapy Via Multi-beam IMRT
Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score83.2 (34.4 to 100)
SecondaryMedian Follow-up Period

Median follow-up period of the enrolled cohort

Time frame:
up to 82 months post-radiation therapy
Reported as:
Median · months
Median Follow-up Period
monthsRadiation Therapy Via Multi-beam IMRT
Median Follow-up Period53.4 (0 to 82)

Adverse events

Collected over 5-7 months following the completion of radiation therapy, up to 82 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Radiation Therapy Via Multi-beam IMRT33/116 (28.4%)10/116 (8.6%)3/116 (2.6%)
Most frequent serious events
Showing 10 of 17
Most frequent serious events
EventRadiation Therapy Via Multi-beam IMRT
DyspneaRespiratory, thoracic and mediastinal disorders2/116
Inf norm ANC/gr1/2 neut-Cellulitis(skin)Skin and subcutaneous tissue disorders2/116
SeizureNervous system disorders2/116
Back PainMusculoskeletal and connective tissue disorders1/116
Breast InfectionInfections and infestations1/116
Death not assoc w CTCAE term-Disease prog NOSGeneral disorders1/116
DysarthriaNervous system disorders1/116
Fever (in the absence of neutropenia)General disorders1/116
Muscle weakness - Whole body/generalMusculoskeletal and connective tissue disorders1/116
Nervous system disorders - Other, specifyNervous system disorders1/116
Most frequent other events
Most frequent other events
EventRadiation Therapy Via Multi-beam IMRT
CoughRespiratory, thoracic and mediastinal disorders1/116
PruritisSkin and subcutaneous tissue disorders1/116
Rash: dermatitis assoc w/ rad-Skin and subcutaneous tissue disorders1/116

Baseline characteristics

1 participant is male. A deviation to treat him per protocol was submitted and approved because using multi-beam radiation as part of the study was the best way to treat the study participant's breast cancer.

Age, Continuous
Age, Continuous(years)Radiation Therapy Via Multi-beam IMRT
Median50 (25 to 77)
Sex: Female, Male
Sex: Female, Male(Participants)Radiation Therapy Via Multi-beam IMRT
Female115
Male1
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Radiation Therapy Via Multi-beam IMRT
Hispanic or Latino7
Not Hispanic or Latino109
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Radiation Therapy Via Multi-beam IMRT
American Indian or Alaska Native0
Asian14
Native Hawaiian or Other Pacific Islander0
Black or African American15
White79
More than one race0
Unknown or Not Reported8
Region of Enrollment
Region of Enrollment(Participants)Radiation Therapy Via Multi-beam IMRT
United States116
08

Study locations

7 sites
  • Memorial Sloan Kettering Basking Ridge (Follow Up Only)
    Basking Ridge, New Jersey 07920, United States
  • Memoral Sloan Kettering Monmouth (Follow Up Only)
    Middletown, New Jersey 07748, United States
  • Memorial Sloan Kettering Commack (Follow Up Only)
    Commack, New York 11725, United States
  • Memorial Sloan Kettering Westchester (Follow Up Only)
    Harrison, New York 10604, United States
  • Memorial Sloan Kettering Cancer Center
    New York, New York 10065, United States
  • Memorial Sloan Kettering Rockville Centre (Follow Up Only)
    Rockville Centre, New York, United States
  • Memorial Sloan Kettering Nassau (Follow Up Only)
    Uniondale, New York 11553, United States
09

References and documents

Publications

  • Ho AY, Ballangrud A, Li G, Gupta GP, McCormick B, Gewanter R, Gelblum D, Zinovoy M, Mueller B, Mychalczak B, Dutta P, Borofsky K, Parhar P, Reyngold M, Braunstein LZ, Chawla M, Krause K, Freeman N, Siu CT, Cost Z, Arnold BB, Zhang Z, Powell SN. Long-Term Pulmonary Outcomes of a Feasibility Study of Inverse-Planned, Multibeam Intensity Modulated Radiation Therapy in Node-Positive Breast Cancer Patients Receiving Regional Nodal Irradiation. Int J Radiat Oncol Biol Phys. 2019 Apr 1;103(5):1100-1108. doi: 10.1016/j.ijrobp.2018.11.045. Epub 2018 Nov 30. PubMed 30508620 ↗

Study documents

  • Protocol and statistical analysis plan · Jun 11, 2019

Documents are hosted by the registry — open the source record to download them.

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01127373
Lead sponsor
Memorial Sloan Kettering Cancer Center
Responsible party
Sponsor
First posted
May 20, 2010
Start date
May 11, 2010
Primary completion
Oct 2, 2019
Completion
Oct 2, 2019
Results posted
Apr 20, 2021
Last update
Apr 20, 2021

Study contacts

Simon Powell, MD
principal investigator · Memorial Sloan Kettering Cancer Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Breast Neoplasms→

Other studies from this sponsor

Memorial Sloan Kettering Cancer Center

Start the discussion