Breast NeoplasmsNCT00321048
Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With ABC
A study testing Active Breathing Coordinator in people with Breast Neoplasms and Carcinoma, Ductal, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms, Carcinoma, Ductal, Adenocarcinoma
- What is being tested?
- Active Breathing Coordinator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2006to Jan 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Patients requiring oxygen
- Sarcoma or Squamous Cell pathology
- Right-sided breast cancers
- Metastatic disease to the breast
Trial locations and contacts
1 site in 1 country.
United States1 site
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21205
About this study
Official title: Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With Active Breathing Coordinator
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.
Read the 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.
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Adenocarcinoma
- Being tested
- Active Breathing Coordinator
- Keywords
- breast cancer, SPECT, ABC device, Invasive adenocarcinoma of the left breast, Ductal Carcinoma In Situ of the left breast
- Medical subject headings
- Breast Neoplasms, Carcinoma, Ductal, Adenocarcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Breathing CoordinatorDevice
A SPECT scan will be used to determine if the active breathing device reduces radiation toxicities.
| Study group | Role | What they receive |
|---|---|---|
| ABC (Active Breathing coordinator) | Experimental | Patients are randomized to ABC arm will receive radiation with ABC. Cardiac perfusion will be assessed at baseline and 6 months after treatment and the difference will be compared to that seen in the No ABC arm. Receives: Device: Active Breathing Coordinator |
| No Active Breathing Coordinator | No intervention | Patients randomized to the No ABC arm will receive radiation without ABC.Cardiac perfusion will be assessed at baseline and 6 months after treatment and the difference will be compared to that seen in the ABC arm. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (pre-radiation) to 6 months (post-radiation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study startJun 2006
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Left breast/chest wall irradiation with or without ABC (active breathing coordinator)
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Responsible party
- Sponsor
- Investigators
- Richard Zellars, M.D., Principal investigator, Sidney Kimmel Comprehensive Cancer Center- Dept. Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321048
- Sponsor's protocol ID
- J0609
- Other IDs
- NA_00002394
- Status last verified
- Feb 2025
- First submitted
- 1 May 2006
- Last updated
- 28 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No
Publications
Zellars R, Bravo PE, Tryggestad E, Hopfer K, Myers L, Tahari A, Asrari F, Ziessman H, Garrett-Mayer E. SPECT analysis of cardiac perfusion changes after whole-breast/chest wall radiation therapy with or without active breathing coordinator: results of a randomized phase 3 trial. Int J Radiat Oncol Biol Phys. 2014 Mar 15;88(4):778-85. doi: 10.1016/j.ijrobp.2013.12.035.
PubMed 24606847
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spect Analysis of Cardiac Perfusion Changes After Whole Breast/Chest Wall Radiation Therapy With Active Breathing Coordinator
- ClinicalTrials.gov ID
- NCT00321048
- Acronym / sponsor ID
- J0609
- Conditions
- Breast Neoplasms, Carcinoma, Ductal, Adenocarcinoma
- Keywords
- breast cancer, SPECT, ABC device, Invasive adenocarcinoma of the left breast, Ductal Carcinoma In Situ of the left breast
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Breast Cancer Research Foundation
- Study start
- Jun 2006
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 3 May 2006 (estimated)
- Results
- Posted 19 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Left breast/chest wall irradiation with or without ABC (active breathing coordinator)
| Arm | Type | Receives |
|---|---|---|
| ABC (Active Breathing coordinator) | Experimental | Device: Active Breathing CoordinatorPatients are randomized to ABC arm will receive radiation with ABC. Cardiac perfusion will be assessed at baseline and 6 months after treatment and the difference will be compared to that seen in the No ABC arm. |
| No Active Breathing Coordinator | No intervention | –Patients randomized to the No ABC arm will receive radiation without ABC.Cardiac perfusion will be assessed at baseline and 6 months after treatment and the difference will be compared to that seen in the ABC arm. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- Patients requiring oxygen
- Sarcoma or Squamous Cell pathology
- Right-sided breast cancers
- Metastatic disease to the breast
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Breathing CoordinatorA SPECT scan will be used to determine if the active breathing device reduces radiation toxicities. | Device | ABC (Active Breathing coordinator) |
Primary outcome
Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24606847Zellars R, Bravo PE, Tryggestad E, Hopfer K, Myers L, Tahari A, Asrari F, Ziessman H, Garrett-Mayer E. SPECT analysis of cardiac perfusion changes after whole-breast/chest wall radiation therapy with or without active breathing coordinator: results of a randomized phase 3 trial. Int J Radiat Oncol Biol Phys. 2014 Mar 15;88(4):778-85. doi: 10.1016/j.ijrobp.2013.12.035.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Zellars, M.D. principal investigator
Sidney Kimmel Comprehensive Cancer Center- Dept. Radiation Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Breathing Coordinator in people with Breast Neoplasms and Carcinoma, Ductal, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of Active Breathing Coordinator (ABC) Device as Determined by the Mean Apical Perfusion Score (time frame: Baseline (pre-radiation) to 6 months (post-radiation)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00321048, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.