Breast CancerPhase 1/2NCT00977275
Treatment of T1N0 Invasive Breast Carcinoma by Local Excision Implant
A Phase 1/2 study testing Interstitial Implant Brachytherapy in people with Breast Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The purpose of this study is to evaluate radiation therapy directed to a small region of the breast in women who were recently diagnosed with early stage invasive breast cancer. 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?
- Interstitial Implant Brachytherapy
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1997to May 2013
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low risk of multifocal disease within the breast whose tumor location is favorable for brachytherapy catheter placement
- Diagnosis of invasive breast carcinoma (biopsy or fine needle aspiration cytology) and be clinical stage T1N0 (primary tumor < 2cm, clinically negative nodes)
- Location of primary tumor is not immediately adjacent to the nipple of chest wall
- No evidence of two or more separate tumors within the breast
- All histologic types and pathologic grades of primary tumor
- No extensive intraductal component (substantial intraductal carcinoma away from the primary tumor location)
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- No lymphatic or vascular invasion
- Lymph node staging by sentinel node excision or axillary dissection confirms node negative status (If node positive, implant is used to deliver boost to tumor bed)
- Assessment of final surgical margins should be predominantly negative, but a single small region of focal positivity is allowable as it is for whole breast radiation
- 18 years of age or older
Who cannot join
- Tumor is too close to the chest wall to allow placement of catheters
- Contraindications to radiation therapy are present, including a history of scleroderma, systemic lupus or other active connective tissue disease, pregnancy, or prior chest wall radiation
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: The Treatment of T1N0 Invasive Breast Carcinoma by Local Excision and Interstitial Implant
The purpose of this study is to evaluate radiation therapy directed to a small region of the breast in women who were recently diagnosed with early stage invasive breast cancer.
Read the detailed description
- When participants undergo surgery to remove the tumor (lumpectomy), it will be followed by the placement of small flexible tubes throughout the region surrounding the site of operation. These tubes will remain in place for 7-9 days following the surgery.
- The first 2-3 days, the tubes will not contain radioactivity. This time is used to do all the calculations necessary for treatment and to check the findings in the breast tissue that was removed. After 2-3 days, the tubes will be filled with a radioactive wire which will remain in place for the next 5 days. During this period of time, participants will be required to remain within the hospital. At the end of these 5 days, the radioactive wires and tubes will be removed.
- Conditions
- Breast Cancer
- Being tested
- Interstitial Implant Brachytherapy
- Keywords
- early stage invasive breast cancer, Partial breast irradiation, interstitial implant
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interstitial Implant BrachytherapyRadiation
Via tubes placed at the time of wide local excision delivered over 5 days
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if interstitial implant brachytherapy to radical radiation doses is feasible following wide local excision of T1N0 breast carcinoma
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2009 (estimated)
- Study startJun 1997
- Primary completionMay 2006
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alphonse Taghian, MD, PhD, Massachusetts General Hospital
- Investigators
- Alphonse Taghian, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977275
- Sponsor's protocol ID
- 97-585
- Status last verified
- Apr 2017
- First submitted
- 11 Sep 2009
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hattangadi JA, Powell SN, MacDonald SM, Mauceri T, Ancukiewicz M, Freer P, Lawenda B, Alm El-Din MA, Gadd MA, Smith BL, Taghian AG. Accelerated partial breast irradiation with low-dose-rate interstitial implant brachytherapy after wide local excision: 12-year outcomes from a prospective trial. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):791-800. doi: 10.1016/j.ijrobp.2011.09.003. Epub 2011 Nov 16.
PubMed 22099046Lawenda BD, Taghian AG, Kachnic LA, Hamdi H, Smith BL, Gadd MA, Mauceri T, Powell SN. Dose-volume analysis of radiotherapy for T1N0 invasive breast cancer treated by local excision and partial breast irradiation by low-dose-rate interstitial implant. Int J Radiat Oncol Biol Phys. 2003 Jul 1;56(3):671-80. doi: 10.1016/s0360-3016(03)00071-3.
PubMed 12788172
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of T1N0 Invasive Breast Carcinoma by Local Excision and Interstitial Implant
- ClinicalTrials.gov ID
- NCT00977275
- Acronym / sponsor ID
- 97-585
- Conditions
- Breast Cancer
- Keywords
- early stage invasive breast cancer, Partial breast irradiation, interstitial implant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Jun 1997
- Primary completion
- May 2006 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 15 Sep 2009 (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 evaluate radiation therapy directed to a small region of the breast in women who were recently diagnosed with early stage invasive breast cancer.
Detailed description
- When participants undergo surgery to remove the tumor (lumpectomy), it will be followed by the placement of small flexible tubes throughout the region surrounding the site of operation. These tubes will remain in place for 7-9 days following the surgery.
- The first 2-3 days, the tubes will not contain radioactivity. This time is used to do all the calculations necessary for treatment and to check the findings in the breast tissue that was removed. After 2-3 days, the tubes will be filled with a radioactive wire which will remain in place for the next 5 days. During this period of time, participants will be required to remain within the hospital. At the end of these 5 days, the radioactive wires and tubes will be removed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Low risk of multifocal disease within the breast whose tumor location is favorable for brachytherapy catheter placement
- Diagnosis of invasive breast carcinoma (biopsy or fine needle aspiration cytology) and be clinical stage T1N0 (primary tumor < 2cm, clinically negative nodes)
- Location of primary tumor is not immediately adjacent to the nipple of chest wall
- No evidence of two or more separate tumors within the breast
- All histologic types and pathologic grades of primary tumor
Key exclusion criteria (2 listed)
- Tumor is too close to the chest wall to allow placement of catheters
- Contraindications to radiation therapy are present, including a history of scleroderma, systemic lupus or other active connective tissue disease, pregnancy, or prior chest wall radiation
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 |
|---|---|---|
| Interstitial Implant BrachytherapyVia tubes placed at the time of wide local excision delivered over 5 days | Radiation | – |
Primary outcome
To determine if interstitial implant brachytherapy to radical radiation doses is feasible following wide local excision of T1N0 breast carcinoma
Time frame: 3 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 11 Apr 2017.
- Results publication: PubMed 22099046Hattangadi JA, Powell SN, MacDonald SM, Mauceri T, Ancukiewicz M, Freer P, Lawenda B, Alm El-Din MA, Gadd MA, Smith BL, Taghian AG. Accelerated partial breast irradiation with low-dose-rate interstitial implant brachytherapy after wide local excision: 12-year outcomes from a prospective trial. Int J Radiat Oncol Biol Phys. 2012 Jul 1;83(3):791-800. doi: 10.1016/j.ijrobp.2011.09.003. Epub 2011 Nov 16.
- Results publication: PubMed 12788172Lawenda BD, Taghian AG, Kachnic LA, Hamdi H, Smith BL, Gadd MA, Mauceri T, Powell SN. Dose-volume analysis of radiotherapy for T1N0 invasive breast cancer treated by local excision and partial breast irradiation by low-dose-rate interstitial implant. Int J Radiat Oncol Biol Phys. 2003 Jul 1;56(3):671-80. doi: 10.1016/s0360-3016(03)00071-3.
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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.
Alphonse Taghian, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Interstitial Implant Brachytherapy in people with Breast Cancer, run by Massachusetts General Hospital 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 10 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 11 Apr 2017. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To determine if interstitial implant brachytherapy to radical radiation doses is feasible following wide local excision of T1N0 breast carcinoma (time frame: 3 years). 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 NCT00977275, which also lists 2 linked publications.
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 11 Apr 2017.