Breast CancerNCT04917640
Registry for Accelerated Partial Breast Irradiation With (SBRT) or (IMRT)
An observational study of Breast Cancer, run by GenesisCare USA at 1 site in United States.
Trial summary
This is a registry study that will be used to evaluate external beam radiation therapy methods for the accelerated treatment of breast cancer. Patients are being asked to take part in this registry because they have breast cancer and desire treatment with accelerated partial breast irradiation to be delivered by… Read more about this study
- Who is it for?
- Ages 50 to 100 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2021to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 50 to 100 years
- Women only
- Adult, Older adult
Study population: Women with greater than or equal to 50 years old and who have been diagnosed with Low to intermediate DCIS
Who may be able to join
- Greater than or equal to 50 years old Low to intermediate DCIS Tumor size < or = to 2cm
Who cannot join
- BRCA positive Lobular histology Angiolymphatic invasion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accelerated Partial Breast Irradiation (PBI) With Stereotactic Body Radiation Therapy (SBRT) or Intensity Modulated Radiation Therapy (IMRT)
This is a registry study that will be used to evaluate external beam radiation therapy methods for the accelerated treatment of breast cancer. Patients are being asked to take part in this registry because they have breast cancer and desire treatment with accelerated partial breast irradiation to be delivered by external beam methods.
- Conditions
- Breast Cancer
- Being tested
- Radiation Therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation TherapyRadiation
Either SBRT or IMRT radiation therapy
| Study group | Role | What they receive |
|---|---|---|
| SBRT | Patients treated with Stereotactic Body Radiation Therapy (SBRT) Receives: Radiation: Radiation Therapy | |
| IMRT | Patients treated with Intensity Modulated Radiation Therapy (IMRT) Receives: Radiation: Radiation Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment and toxicity-related adverse events as assessed by CTCAE v4.0".
Toxicity will be assessed using the CTCAEv4.0 and recorded.
Measured: Through study completion, an average of 12 months
Secondary outcomes (1)
Number of participants with ipsilateral breast recurrence
Number of participants with pathologically confirmed ipsilateral breast recurrence.
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study startJun 2021 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionDec 2024 (estimated)
Why it stopped: A revised study has been listed here for us.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- GenesisCare USA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sharon Salenius, MPH, Study director, Fundacion GenesisCare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04917640
- Sponsor's protocol ID
- APBI Registry
- Status last verified
- Jun 2021
- First submitted
- 24 May 2021
- Last updated
- 8 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accelerated Partial Breast Irradiation (PBI) With Stereotactic Body Radiation Therapy (SBRT) or Intensity Modulated Radiation Therapy (IMRT)
- ClinicalTrials.gov ID
- NCT04917640
- Acronym / sponsor ID
- APBI Registry
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: A revised study has been listed here for us.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- GenesisCare USAUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a registry study that will be used to evaluate external beam radiation therapy methods for the accelerated treatment of breast cancer. Patients are being asked to take part in this registry because they have breast cancer and desire treatment with accelerated partial breast irradiation to be delivered by external beam methods.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SBRT | – | Radiation: Radiation TherapyPatients treated with Stereotactic Body Radiation Therapy (SBRT) |
| IMRT | – | Radiation: Radiation TherapyPatients treated with Intensity Modulated Radiation Therapy (IMRT) |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women with greater than or equal to 50 years old and who have been diagnosed with Low to intermediate DCIS
Key inclusion criteria (1 listed)
- Greater than or equal to 50 years old Low to intermediate DCIS Tumor size < or = to 2cm
Key exclusion criteria (1 listed)
- BRCA positive Lobular histology Angiolymphatic invasion
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 |
|---|---|---|
| Radiation TherapyEither SBRT or IMRT radiation therapy | Radiation | IMRT, SBRT |
Primary outcome
Number of participants with treatment and toxicity-related adverse events as assessed by CTCAE v4.0".
Time frame: Through study completion, an average of 12 months
Toxicity will be assessed using the CTCAEv4.0 and recorded.
1 secondary outcome
Number of participants with ipsilateral breast recurrence
Time frame: Through study completion, an average of 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2021.
- 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.
Sharon Salenius, MPH study director
Fundacion GenesisCare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by GenesisCare USA 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 8 Sep 2021. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Number of participants with treatment and toxicity-related adverse events as assessed by CTCAE v4.0". (time frame: Through study completion, an average of 12 months). 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 8 Sep 2021.