Adenocarcinoma, Breast Neoplasms, Carcinoma, Ductal
Conditions
Keywords
breast cancer, SPECT, ABC device, Invasive adenocarcinoma of the left breast, Ductal Carcinoma In Situ of the left breast
Brief summary
Cardiac perfusion changes have been seen after whole breast / chest wall irradiation for breast cancer. The Active Breathing Coordinator (ABC) device theoretically decreases radiation exposure to the heart during radiation for breast cancer. In this trial cardiac perfusion changes or lack thereof will be quantified in women treated with radiation for breast cancer while using the ABC device. The control group of the study will consist of patients randomized to radiation therapy without the ABC device.
Detailed description
50 left sided breast cancer patients will be randomized to receive breast/chest wall irradiation with or without ABC. Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday. After the completion of radiation therapy, patients will be seen on the following schedule: A follow up examination will take place every 3-6 months for the first two years, then every 4-6 months for years for the next 3 years. After 5 years follow-up evaluations will occur annually. A SPECT scan will be obtained at 6 months post therapy. Patients must be 18 and older and must have histologically confirmed (by routine H&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast. Patients must have also undergone a segmental mastectomy (SM) or Mastectomy. Patients must not have received prior radiation therapy to the breast at any time for any reason. Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen.
Interventions
DEVICEActive Breathing Coordinator
A SPECT scan will be used to determine if the active breathing device reduces radiation toxicities.
Sponsors
Breast Cancer Research Foundation
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Left breast/chest wall irradiation with or without ABC (active breathing coordinator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient must be 18 and older * Patients must have histologically confirmed (by routine H&E staining) invasive adenocarcinoma or Ductal Carcinoma In Situ of the left breast. * Patients must have undergone a segmental mastectomy (SM) or Mastectomy * Patients must not have received prior radiation therapy to the breast at any time for any reason. * Any patient with active local-regional disease prior to registration is not eligible. * Patients must not be pregnant due to the potential for fetal harm as a result of this treatment regimen. Women of child-bearing age will be given a serum pregnancy test prior to study entry to ensure they are not pregnant. Women of child-bearing potential must use effective non-hormonal contraception while undergoing radiation therapy. * Patients must not have a serious medical or psychiatric illness which prevents informed consent or compliance with treatment. * All patients must be informed of the investigational nature of this study and give written informed consent in accordance with institutional and federal guidelines.
Exclusion criteria
* Patients requiring oxygen * Sarcoma or Squamous Cell pathology * Right-sided breast cancers * Metastatic disease to the breast
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score | Baseline (pre-radiation) to 6 months (post-radiation) | Efficacy of the ABC device in protecting the heart from radiation (XRT) damage in patients with L breast cancer is determined by the change in cardiac perfusion (mean apical perfusion score) as measured by SPECT between baseline and 6 month follow up. A score of 1 represents an equivocal or mild reduction in perfusion, 2 represents moderately reduced perfusion, 3 represents severely reduced perfusion, and 4 indicates absent perfusion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active Breathing Coordination Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday.
Patients in this group were treated with Active Breathing Coordinator:
A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion | 22 |
| No Active Breathing Coordination Patients will receive radiation therapy at a dose of 180-200 cGy per fraction for 23-27 fractions to a total dose of 4600 - 4860 cGy. Additional radiation to the lumpectomy bed or mastectomy scar is at the discretion of the treating physician. The total dose to the tumor bed or mastectomy scar cannot exceed 6600cGy. Treatments will be given Monday through Friday.
(Patient ARE NOT treated with ABC) A SPECT scan will be obtained at baseline and at 6 months follow to determine changes in cardiac perfusion | 21 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 6 | 8 |
Baseline characteristics
| Characteristic | Active Breathing Coordination | No Active Breathing Coordination | Total |
|---|---|---|---|
| Age, Continuous | 52.8 years | 58.7 years | 55.8 years |
| Region of Enrollment United States | 22 Participants | 21 Participants | 43 Participants |
| Sex: Female, Male Female | 22 Participants | 21 Participants | 43 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 22 | 1 / 21 |
| other Total, other adverse events | 0 / 22 | 0 / 21 |
| serious Total, serious adverse events | 0 / 22 | 0 / 21 |
Outcome results
Primary
Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score
Efficacy of the ABC device in protecting the heart from radiation (XRT) damage in patients with L breast cancer is determined by the change in cardiac perfusion (mean apical perfusion score) as measured by SPECT between baseline and 6 month follow up. A score of 1 represents an equivocal or mild reduction in perfusion, 2 represents moderately reduced perfusion, 3 represents severely reduced perfusion, and 4 indicates absent perfusion.
Time frame: Baseline (pre-radiation) to 6 months (post-radiation)
Population: We understand the reporting score on a scale however, in this case the Mean Perfusion Score was utilized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Active Breathing Coordination | Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score | Mean Apical Perfusion Pre XRT | 1.2 Mean Perfusion Score | Standard Deviation 0.9 |
| Active Breathing Coordination | Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score | Mean Apical Perfusion Post XRT | 2.1 Mean Perfusion Score | Standard Deviation 1.5 |
| No Active Breathing Coordination | Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score | Mean Apical Perfusion Pre XRT | 2.0 Mean Perfusion Score | Standard Deviation 1.5 |
| No Active Breathing Coordination | Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score | Mean Apical Perfusion Post XRT | 2.5 Mean Perfusion Score | Standard Deviation 1.6 |