Breast Cancer
Conditions
Keywords
Breast, Radiation, Multi-Beam Intensity-Modulated Radiation, post mastectomy, post partial mastectomy, node-positive breast cancer, 10-025
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.
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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Mean FEV1 at Baseline | Baseline | Participants FEV1 (forced expiratory volume in 1 second) measured at baseline |
| 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 |
| 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. |
| 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. |
| Median Follow-up Period | up to 82 months post-radiation therapy | Median follow-up period of the enrolled cohort |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 116 |
| Total | 116 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Disease progression | 1 |
| Overall Study | Lost to Follow-up | 7 |
| Overall Study | Not Treated | 3 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Radiation Therapy Via Multi-beam IMRT |
|---|---|
| Age, Continuous | 50 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 109 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 14 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 8 Participants |
| Race (NIH/OMB) White | 79 Participants |
| Region of Enrollment United States | 116 Participants |
| Sex: Female, Male Female | 115 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 33 / 116 |
| other Total, other adverse events | 3 / 116 |
| serious Total, serious adverse events | 10 / 116 |
Outcome results
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Radiation Therapy Via Multi-beam IMRT | Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification | Discontinued IMRT due to disease progression | 1 Participants |
| Radiation Therapy Via Multi-beam IMRT | Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification | Completed IMRT | 111 Participants |
| Radiation Therapy Via Multi-beam IMRT | Count of Participants Receiving Adjuvant Radiation Therapy Via Multi-beam IMRT Using Daily 3D Position Verification | Ineligible | 4 Participants |
Secondary
Mean FEV1 at Baseline
Participants FEV1 (forced expiratory volume in 1 second) measured at baseline
Time frame: Baseline
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Radiation Therapy Via Multi-beam IMRT | Mean FEV1 at Baseline | 2.6 liters |
Secondary
Median Follow-up Period
Median follow-up period of the enrolled cohort
Time frame: up to 82 months post-radiation therapy
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Radiation Therapy Via Multi-beam IMRT | Median Follow-up Period | 53.4 months |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Radiation Therapy Via Multi-beam IMRT | Number of Participants Evaluated for Acute and Late Cutaneous Toxicity | 116 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Radiation Therapy Via Multi-beam IMRT | Number of Participants Evaluated for Late Subcutaneous Fibrosis | Experienced Skin & subcutaneous tissue disorders | 1 Participants |
| Radiation Therapy Via Multi-beam IMRT | Number of Participants Evaluated for Late Subcutaneous Fibrosis | Did not experience skin & subcutaneous tissue diso | 115 Participants |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Radiation Therapy Via Multi-beam IMRT | Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg) | 18.8 mL/min/mmHg |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Radiation Therapy Via Multi-beam IMRT | Severity of Radiation Pneumonitis (RP) Measured by DLCO/Diffuse Capacity of Lung for CO2(mL/Min/mmHg) | 18.5 mL/min/mmHg |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Radiation Therapy Via Multi-beam IMRT | Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%) | 79.6 FEV1 / FVC percentage |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Radiation Therapy Via Multi-beam IMRT | Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%) | 2.6 1 sec/FEV1 (Liters) |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Radiation Therapy Via Multi-beam IMRT | Severity of Radiation Pneumonitis (RP) Measured by FEV1/FVC (Forced Vital Capacity) (%) | 80.1 FEV1 / FVC percentage |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Radiation Therapy Via Multi-beam IMRT | Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score | 83.2 units on a scale |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Radiation Therapy Via Multi-beam IMRT | Severity of Radiation Pneumonitis (RP) Measured by the Mean of Total Community-Acquired Pneumonia (CAP) Score | 84.8 units on a scale |