Breast CancerNCT00328783
Using the Active Breathing Control Device to Reduce Radiation Side Effects to Critical Structures in Breast Cancer
A study testing Active Breathing Coordinator (ABC) and Radiation Therapy in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of a device that helps coordinate the breathing cycle in the radiation treatment of the breast in order to minimize the radiation dose to the normal structures around the breast. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Active Breathing Coordinator (ABC) and Radiation Therapy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Jul 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Requiring adjuvant or post mastectomy radiation therapy with tangential fields or 3-fields
- Adequate pulmonary function
- Presence of 5 cc of the heart or liver with the simulation fields
- Karnofsky Performance Status (KPS) equal to or greater than 70
Who cannot join
- Pregnant women
- Patients who have had previous ipsilateral breast or thoracic radiation therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19017
About this study
Official title: A Pilot Study Investigating Active Breathing Coordinator (ABC) to Reduce Radiation Dose to Normal Structures in Breast Cancer Patients
The purpose of this study is to evaluate the use of a device that helps coordinate the breathing cycle in the radiation treatment of the breast in order to minimize the radiation dose to the normal structures around the breast.
Read the detailed description
The Active Breathing Coordinator (ABC) allows for temporary and reproducible immobilization of internal thoracic structures by monitoring the patient's breathing cycle and implementing a breath hold at a predefined lung volume level. While ABC is FDA approved and commercially available, only preliminary dosimetric data is available on a small number of patients with breast cancer. There is some data using ABC for intrathoracic malignancies, which shows that it is feasible and safe to use. ABC can be used to optimize the distance between chest wall, heart and liver. This allows adequate treatment of the breast and underlying chest wall while minimizing irradiated cardiac and liver volume.
- Conditions
- Breast Cancer
- Being tested
- Active Breathing Coordinator (ABC), Radiation Therapy
- Keywords
- Breast cancer, Active Breathing Control, Active Breathing Coordinator, ABC
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Breathing Coordinator (ABC)Device
Also called ABC
The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms.
Radiation TherapyRadiation
| Study group | Role | What they receive |
|---|---|---|
| Active Breathing Coordinator | Experimental | Patients breathe through the ABC device Receives: Device: Active Breathing Coordinator (ABC); Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues
To evaluate the magnitude of reduction in irradiated normal tissues (heart and lung) when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing.
The generated dose distributions from the free-breathing vs. ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. Specifically, for the heart, the volume receiving 55 and 40 Gy will be evaluated; for the liver the volume receiving 50 and 36 Gy, and for the lung, the volume receiving 20 Gy. For the contralateral breast the volume receiving 20 Gy, 30 Gy and 50 Gy will be evaluated. Patients will be treated with the ABC device if there is at least 5 % relative reduction in the volume of a normal tissue irradiated to prescription dose.
Measured: At time of radiation
Proportion of Patients With Reduction in Radiation
Measured: 30 days
Secondary outcomes (3)
Toxicity Evaluation
Number of participants that experienced grade three toxicity or higher as a result of treatment.
Measured: 30 days post-treatment
Change in Organs at Risk (OAR) Dosimetric Paramaters
To evaluate the magnitude of change in Mean Heart Dose (MHD) and Left lung dose when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing.
Measured: 30 days post-treatment
Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device.
To monitor the toxicity of treatment of adjuvant radiotherapy for breast cancer with the ABC device.
Measured: 30 days post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startOct 2002
- Primary completionJul 2011
- Study completionJul 2011
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.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pramila Rani Anne, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328783
- Sponsor's protocol ID
- 02U.282
- Other IDs
- 2002-31, JT 1005
- Status last verified
- Apr 2025
- First submitted
- 19 May 2006
- Last updated
- 30 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Investigating Active Breathing Coordinator (ABC) to Reduce Radiation Dose to Normal Structures in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT00328783
- Acronym / sponsor ID
- 02U.282
- Conditions
- Breast Cancer
- Keywords
- Breast cancer, Active Breathing Control, Active Breathing Coordinator, ABC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 22 May 2006 (estimated)
- Results
- Posted 30 Apr 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the use of a device that helps coordinate the breathing cycle in the radiation treatment of the breast in order to minimize the radiation dose to the normal structures around the breast.
Detailed description
The Active Breathing Coordinator (ABC) allows for temporary and reproducible immobilization of internal thoracic structures by monitoring the patient's breathing cycle and implementing a breath hold at a predefined lung volume level. While ABC is FDA approved and commercially available, only preliminary dosimetric data is available on a small number of patients with breast cancer. There is some data using ABC for intrathoracic malignancies, which shows that it is feasible and safe to use. ABC can be used to optimize the distance between chest wall, heart and liver. This allows adequate treatment of the breast and underlying chest wall while minimizing irradiated cardiac and liver volume.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active Breathing Coordinator | Experimental | Device: Active Breathing Coordinator (ABC), Radiation: Radiation TherapyPatients breathe through the ABC device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Requiring adjuvant or post mastectomy radiation therapy with tangential fields or 3-fields
- Adequate pulmonary function
- Presence of 5 cc of the heart or liver with the simulation fields
- Karnofsky Performance Status (KPS) equal to or greater than 70
Key exclusion criteria (2 listed)
- Pregnant women
- Patients who have had previous ipsilateral breast or thoracic radiation therapy
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 Coordinator (ABC)Also: ABCThe generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. | Device | Active Breathing Coordinator |
| Radiation Therapy | Radiation | Active Breathing Coordinator |
Primary outcome
Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues
Time frame: At time of radiation
To evaluate the magnitude of reduction in irradiated normal tissues (heart and lung) when using the Active Breathing Coordinator (ABC) in breast patients, as compared to standard, free-breathing. The generated dose distributions from the free-breathing vs. ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms. Specifically, for the heart, the volume receiving 55 and 40 Gy will be evaluated; for the liver the volume receiving 50 and 36 Gy, and for the lung, the volume receiving 20 Gy. For the contralateral breast the volume receiving 20 Gy, 30 Gy and 50 Gy will be evaluated. Patients will be treated with the ABC device if there is at least 5 % relative reduction in the volume of a normal tissue irradiated to prescription dose.
Proportion of Patients With Reduction in Radiation
Time frame: 30 days
3 secondary outcomes
Toxicity Evaluation
Time frame: 30 days post-treatment
Change in Organs at Risk (OAR) Dosimetric Paramaters
Time frame: 30 days post-treatment
Number of Participants With Toxicity of Treatment of Adjuvant Radiotherapy for Breast Cancer With the ABC Device.
Time frame: 30 days post-treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalsLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruitingPhase 2
Tamoxifen Citrate or Z-Endoxifen Hydrochloride in Treating Patients With Locally Advanced or Metastatic, Estrogen Receptor-Positive, HER2-Negative Breast Cancer
Recurrent Breast Carcinoma, Stage III Breast Cancer AJCC v7
RecruitingPhase 1/2
A Study to Evaluate the Effect of GDC-4198 Alone and in Combination With Giredestrant Versus Abemaciclib and Giredestrant in Participants With Locally Advanced or Metastatic Estrogen Receptor-Positive (ER+), Human Epidermal Growth Factor Receptor-Negative (HER2-) Breast Cancer
Breast Cancer
Not yet recruiting
Podcast-Based Psychosocial Support for Women Newly Diagnosed With Breast Cancer
Breast Cancer
Recruiting
A Study of Skipping Radiation Therapy in People With Breast Cancer
HER2-positive Breast Cancer, Breast Cancer
Active, not recruiting
Dance Study for Post-surgical Pain in Breast Cancer Survivors
Breast Cancer, Survivorship
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.
Pramila Rani Anne, MD principal investigator
Thomas Jefferson University
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 (ABC) and Radiation Therapy in people with Breast Cancer, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University 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 4 inclusion and 2 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 30 Apr 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 30 Apr 2014). 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?
Dosimetric Evaluation Magnitude of Reduction in Irradiated Normal Tissues (time frame: At time of radiation). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2025.