Breast CancerPBINCT02272400
Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation
A study testing IGRT for prone partial breast irradiation (PBI) in people with Breast Cancer, run by NYU Langone Health at 1 site in United States.
Trial summary
Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation.[1] No type I or II evidence is currently available to demonstrate equivalence to standard whole breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and RTOG (NSABP B-39 and RTOG 0413) is currently… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- IGRT for prone partial breast irradiation (PBI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2007to 29 Oct 2014
- Phase
- Interventional
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post-menopausal women defined as either:
- at least 2 years without menstrual period or
- patients older than 50 with serological evidence of post-menopausal status or
- hysterectomized patients of any age with FSH confirmation of post-menopausal status
- pT1 breast cancer, excised with negative margins
- pN0 or sentinel node negative or N0 clinically if the tumor is < 1 cm in size
Who cannot join
- Previous radiation therapy to the ipsilateral breast
- Presence of a proportion of DCIS in the core biopsy specimen which is compatible with extensive intraductal component (EIC)
Trial locations and contacts
1 site in 1 country.
United States1 site
Laura and Isaac Perlmutter Cancer Center at NYU
New York, New York, 10016
About this study
Official title: Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation (PBI)
Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation.[1] No type I or II evidence is currently available to demonstrate equivalence to standard whole breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and RTOG (NSABP B-39 and RTOG 0413) is currently accruing patients, comparing whole breast radiotherapy to PBI, either by brachytherapy or external beam techniques (EB). Until the results of this or similar trials are available, PBI remains a research domain, and it should be offered to patients only in the context of a clinical experimental protocol.
Read the detailed description
Despite the fact that less extensive experience than that of brachytherapy is available, PBI delivery through an external-beam has many advantages. First of all, it is likely to be more acceptable to the patient since it is non-invasive and it does not require a surgical procedure or anesthesia. Moreover, since it is delivered after surgery, the pathological analysis of the segmental mastectomy specimen is available to inform the selection of the best candidates. In addition, EB-PBI is likely to become more widely reproducible, since it does not rely on the experience and skills of the radiation oncologist performing the brachytherapy implant. Besides, once the technique is established, it can be widely applied at any facility provided with a linear accelerator, without the risk presented by some brachytherapy approaches that can not be completed because of the unfavorable interplay of patient's anatomy with the technical limitations of the applicator. Finally, in terms of health care economics, an external beam approach spares the costs of an extra surgical procedure and that of several days of hospitalization (in the case of LDR brachytherapy).
- Conditions
- Breast Cancer
- Being tested
- IGRT for prone partial breast irradiation (PBI)
- Keywords
- image guided radiation therapy, partial breast irradiation, breast cancer, breast, cancer, breast preservation, IGRT, PBI
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGRT for prone partial breast irradiation (PBI)Other
Also called IGRT, PBI
IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy. Simulation and treatment will be started within 50 days from surgery in order to maximize the chances of optimal lumpectomy cavity visualization on the planning and cone beam CT scans. All patients will be followed monthly for the first 90 days then q3 months for the first year, then yearly for the next 10 years.
| Study group | Role | What they receive |
|---|---|---|
| IGRT of prone partial breast | Experimental | IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy. Receives: Other: IGRT for prone partial breast irradiation (PBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the outcome of applying IGRT to PBI
Apply IGRT to PBI as part of breast preservation in post-menopausal women with T1 breast cancers and acquire preliminary data on the role of this tool to assure correct targeting.
Measure local recurrence within the field of conformal radiation as well as local recurrence outside the field
Measured: 10 years
Secondary outcomes (2)
Feasibility of accelerated dose fractionation
Assess the feasibility of an accelerated dose fractionation (600 cGy x 5) when given over five consecutive day by measuring the acute and late radiation toxicity
Measured: 1 - 10 years
Genetic pre-disposition of patient to post-treatment radiation fibrosis
Prospectively determine if genetic factors can be identified which may predispose a patient to the development of post-treatment radiation fibrosis
Measured: 1 - 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study start7 Aug 2007
- Primary completion29 Oct 2014
- Study completion29 Oct 2014
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.
- More trials run by NYU Langone HealthThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Perez, M.D., Principal investigator, NYU Langone Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272400
- Sponsor's protocol ID
- 07-582
- Acronym
- PBI
- Status last verified
- Jan 2021
- First submitted
- 8 Oct 2014
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation (PBI)
- ClinicalTrials.gov ID
- NCT02272400
- Acronym / sponsor ID
- PBI / 07-582
- Conditions
- Breast Cancer
- Keywords
- image guided radiation therapy, partial breast irradiation, breast cancer, breast, cancer, breast preservation, IGRT, PBI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 7 Aug 2007 (actual)
- Primary completion
- 29 Oct 2014 (actual)
- Study completion
- 29 Oct 2014 (actual)
- First posted
- 23 Oct 2014 (estimated)
- 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.
Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation.[1] No type I or II evidence is currently available to demonstrate equivalence to standard whole breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and RTOG (NSABP B-39 and RTOG 0413) is currently accruing patients, comparing whole breast radiotherapy to PBI, either by brachytherapy or external beam techniques (EB). Until the results of this or similar trials are available, PBI remains a research domain, and it should be offered to patients only in the context of a clinical experimental protocol.
Detailed description
Despite the fact that less extensive experience than that of brachytherapy is available, PBI delivery through an external-beam has many advantages. First of all, it is likely to be more acceptable to the patient since it is non-invasive and it does not require a surgical procedure or anesthesia. Moreover, since it is delivered after surgery, the pathological analysis of the segmental mastectomy specimen is available to inform the selection of the best candidates. In addition, EB-PBI is likely to become more widely reproducible, since it does not rely on the experience and skills of the radiation oncologist performing the brachytherapy implant. Besides, once the technique is established, it can be widely applied at any facility provided with a linear accelerator, without the risk presented by some brachytherapy approaches that can not be completed because of the unfavorable interplay of patient's anatomy with the technical limitations of the applicator. Finally, in terms of health care economics, an external beam approach spares the costs of an extra surgical procedure and that of several days of hospitalization (in the case of LDR brachytherapy).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IGRT of prone partial breast | Experimental | Other: IGRT for prone partial breast irradiation (PBI)IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Post-menopausal women defined as either:
- pT1 breast cancer, excised with negative margins
- pN0 or sentinel node negative or N0 clinically if the tumor is < 1 cm in size
Key exclusion criteria (2 listed)
- Previous radiation therapy to the ipsilateral breast
- Presence of a proportion of DCIS in the core biopsy specimen which is compatible with extensive intraductal component (EIC)
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 |
|---|---|---|
| IGRT for prone partial breast irradiation (PBI)Also: IGRT, PBIIGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy. Simulation and treatment will be started within 50 days from surgery in order to maximize the chances of optimal lumpectomy cavity visualization on the planning and cone beam CT scans. All patients will be followed monthly for the first 90 days then q3 months for the first year, then yearly for the next 10 years. | Other | IGRT of prone partial breast |
Primary outcome
Measure the outcome of applying IGRT to PBI
Time frame: 10 years
Apply IGRT to PBI as part of breast preservation in post-menopausal women with T1 breast cancers and acquire preliminary data on the role of this tool to assure correct targeting. Measure local recurrence within the field of conformal radiation as well as local recurrence outside the field
2 secondary outcomes
Feasibility of accelerated dose fractionation
Time frame: 1 - 10 years
Genetic pre-disposition of patient to post-treatment radiation fibrosis
Time frame: 1 - 10 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
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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.
Carmen Perez, M.D. principal investigator
NYU Langone Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IGRT for prone partial breast irradiation (PBI) in people with Breast Cancer, run by NYU Langone Health 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 6 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 14 Jan 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Measure the outcome of applying IGRT to PBI (time frame: 10 years). 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 14 Jan 2021.