Early Stage Breast CancerTARGITNCT02364960
Targeted Intraoperative Therapy Registry at Bethesda North Hospital (TARGIT)
An observational study of Early Stage Breast Cancer and Neoplasm of the Breast, run by TriHealth Inc. at 1 site in United States.
Trial summary
The purpose of this study is to create a registry to evaluate the use of intra-operative radiation therapy (IORT) and to study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery, Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Early Stage Breast Cancer, Neoplasm of the Breast, Breast Tumor
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2015to Jan 2016
- How long will I take part?
- 10 Years
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women, aged 45 and greater who have been diagnosed with early stage invasive breast cancer that is suitable for breast conserving surgery.
Who may be able to join
- Female
- Age 45 or greater
- Diagnosed with operable invasive breast cancer, T1 and T2 (< 3.5 cm), N0, M0, confirmed by cytological or histological examination
- Suited for breast conserving surgery
- Have had an ipsilateral (same side as current cancer) diagnostic mammogram within 12 months of enrollment
Who cannot join
- age 44 or less
- Axillary lymph node positive breast cancer
- Invasive lobular cancer
- Tumor size > 3.5 cm
- Extensive Intraductal Component (EIC= > 25% of the lumpectomy specimen involved with ductal carcinoma in situ, DCIS) as assessed on surgical pathologic lumpectomy specimen
- Multicentric cancer in the same breast not amenable to excision with a single lumpectomy
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- Inability to assess pathologic margin status
- Synchronous bilateral breast cancer at the time of diagnosis.
- Ipsilateral breast had a previous cancer and/or prior in-field radiation.
- Patients known to have BRCA1/2 gene mutations
- Neoadjuvant treatment (hormones or chemotherapy)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mary Jo Cropper Family Center for Breast Care
Cincinnati, Ohio, 45242
About this study
Official title: Implementation of the Target Intraoperative Therapy Registry at Bethesda North TriHealth Hospital (TARGIT)
The purpose of this study is to create a registry to evaluate the use of intra-operative radiation therapy (IORT) and to study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery,
Read the detailed description
A registry trial has been designed and modeled after the original successful TARGIT protocol, to continue the use of IORT for a select population of women, and to follow outcomes with regards to local and regional control, toxicity and morbidity. Patients selected for breast conserving surgery, who are considered to have a low risk of local recurrence, are eligible for this registry trial once their informed consent is obtained. This single arm cohort study allows entry of patients who have been diagnosed with early stage breast cancer and whose clinical stage is suitable for treating conservatively (small tumor and no gross nodal involvement). Tumors should not be more than 3.5 cm in size.
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
In-breast local failure and patterns of in-breast failure
In-breast local failure is defined as recurrence of cancer in the ipsilateral (same side) breast. Following IORT, patients will be monitored every 6 months for 3 years, and then annually in years 4 and 5 to determine if cancer has returned. In years 6 through 10 medical records will be reviewed to obtain information on participants' breast cancer status.
Measured: 6 months after IORT through year 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015
- Study completionJan 2016
Why it stopped: Study site will join the TARGIT-US trial in lieu of this trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage 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
- 16 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- TriHealth Hatton Research Institute, Bethesda North Hospital Foundation
- Responsible party
- Principal investigator, Angela N Fellner PhD CCRP, TriHealth Inc.
- Investigators
- Ching Ho, MD PhD, Principal investigator, Mary Jo Cropper Family Center for Breast Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02364960
- Sponsor's protocol ID
- 14-047
- Acronym
- TARGIT
- Status last verified
- Aug 2018
- First submitted
- 26 Jan 2015
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Target Intraoperative Therapy Registry at Bethesda North TriHealth Hospital (TARGIT)
- ClinicalTrials.gov ID
- NCT02364960
- Acronym / sponsor ID
- TARGIT / 14-047
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study site will join the TARGIT-US trial in lieu of this trial
- Enrolment
- 16 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Collaborators
- TriHealth Hatton Research Institute, Bethesda North Hospital Foundation
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 18 Feb 2015 (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.
The purpose of this study is to create a registry to evaluate the use of intra-operative radiation therapy (IORT) and to study the efficacy and toxicity of breast radiotherapy given intra-operatively as a single fraction after breast conserving surgery,
Detailed description
A registry trial has been designed and modeled after the original successful TARGIT protocol, to continue the use of IORT for a select population of women, and to follow outcomes with regards to local and regional control, toxicity and morbidity. Patients selected for breast conserving surgery, who are considered to have a low risk of local recurrence, are eligible for this registry trial once their informed consent is obtained. This single arm cohort study allows entry of patients who have been diagnosed with early stage breast cancer and whose clinical stage is suitable for treating conservatively (small tumor and no gross nodal involvement). Tumors should not be more than 3.5 cm in size.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women, aged 45 and greater who have been diagnosed with early stage invasive breast cancer that is suitable for breast conserving surgery.
Key inclusion criteria (5 listed)
- Female
- Age 45 or greater
- Diagnosed with operable invasive breast cancer, T1 and T2 (< 3.5 cm), N0, M0, confirmed by cytological or histological examination
- Suited for breast conserving surgery
- Have had an ipsilateral (same side as current cancer) diagnostic mammogram within 12 months of enrollment
Key exclusion criteria (11 listed)
- age 44 or less
- Axillary lymph node positive breast cancer
- Invasive lobular cancer
- Tumor size > 3.5 cm
- Extensive Intraductal Component (EIC= > 25% of the lumpectomy specimen involved with ductal carcinoma in situ, DCIS) as assessed on surgical pathologic lumpectomy specimen
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In-breast local failure and patterns of in-breast failure
Time frame: 6 months after IORT through year 10
In-breast local failure is defined as recurrence of cancer in the ipsilateral (same side) breast. Following IORT, patients will be monitored every 6 months for 3 years, and then annually in years 4 and 5 to determine if cancer has returned. In years 6 through 10 medical records will be reviewed to obtain information on participants' breast cancer status.
Results and safety
The study was stopped early (reason given: Study site will join the TARGIT-US trial in lieu of this trial). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- 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.
Ching Ho, MD PhD principal investigator
Mary Jo Cropper Family Center for Breast Care
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 Early Stage Breast Cancer and Neoplasm of the Breast, run by TriHealth Inc. 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 22 Aug 2018. 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 stopped early (reason given: Study site will join the TARGIT-US trial in lieu of this trial). Results are not available in the source record.
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?
In-breast local failure and patterns of in-breast failure (time frame: 6 months after IORT through year 10). 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 22 Aug 2018.