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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Radiation: Multi-Beam Intensity-Modulated Radiation Therapy; Behavioral: BreastQ questionnaire-

• Study Type: Interventional
• Enrollment (Actual): 116
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center

Publications and helpful links

General 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.

Helpful Links

• Memorial Sloan-Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 11, 2010
• Primary Completion (ACTUAL): October 2, 2019
• Study Completion (ACTUAL): October 2, 2019

Study Registration Dates

• First Submitted: May 19, 2010
• First Submitted That Met QC Criteria: May 19, 2010
• First Posted (ESTIMATE): May 20, 2010

Study Record Updates

• Last Update Posted (ACTUAL): April 20, 2021
• Last Update Submitted That Met QC Criteria: March 25, 2021
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: Breast; Radiation; node-positive breast cancer; Multi-Beam Intensity-Modulated Radiation; post mastectomy; post partial mastectomy; 10-025
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 10-025