Breast CancerPhase 2NCT00290654
Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ
A Phase 2 study testing Tamoxifen, Lumpectomy and brachytherapy in people with Breast Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving internal radiation therapy using a special radiation therapy device may kill any tumor cells that remain after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Tamoxifen, Lumpectomy and brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2002to Mar 2013
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ductal carcinoma in situ (DCIS) confirmed by excisional or needle biopsy
- Size: < 3 cm on mammogram
- Unicentric disease
- Ability to place MammoSite device at time of lumpectomy or within 4 weeks of lumpectomy
- Patient Age: ≥ 18 years, no upper limit
- Life expectancy > 5 years
Who cannot join
- Prior history of cancer other than basal or squamous cell skin cancer or in situ cancer of the cervix
- Pregnant or breast feeding
- Multicentric disease
- Diagnosis of collagen vascular diseases, such as systemic lupus erythematosis, scleroderma, or dermatomyositis
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: Twin Cities Brachytherapy Study for Ductal Carcinoma in Situ A Phase II Trial
RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving internal radiation therapy using a special radiation therapy device may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well internal radiation therapy after lumpectomy works in treating women with ductal carcinoma in situ.
Read the detailed description
OBJECTIVES:
Primary
- Determine the ipsilateral breast tumor recurrence rate in women with ductal carcinoma in situ undergoing lumpectomy followed by brachytherapy using the MammoSite^® Radiation Therapy System.
Secondary
- Determine the early and late complication rates and cosmetic outcome in these patients after treatment.
OUTLINE: Patients undergo lumpectomy. Patients with negative tumor margins* (no ink on tumor) undergo placement of the MammoSite^® Radiation Therapy System at the time of lumpectomy or within 4 weeks after surgery.
NOTE: *If positive margins are present, the surgeon may elect to resect the positive margins and then insert a new MammoSite® device if all other eligibility criteria are met.
Beginning 2-5 days after placement of the MammoSite^®, patients undergo brachytherapy through the MammoSite^® twice daily for 5 days (a total of 10 fractions).
After completion of study treatment, patients are followed periodically for ≥ 5 years.
- Conditions
- Breast Cancer
- Being tested
- Tamoxifen, Lumpectomy, brachytherapy
- Keywords
- ductal breast carcinoma in situ, breast cancer in situ
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating, Breast Carcinoma In Situ
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamoxifenDrug
Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient
LumpectomyProcedure or surgery
A standard lumpectomy will be performed with an attempt to remove at least 1 cm of gross margin around the DCIS.
brachytherapyRadiation
Treatment will be given in 10 fractions of 3.4 Gy per fraction twice a day, with a minimum of 6 hours between fractions. In general, brachytherapy will start between 2 - 5 days of implant. All treatments will be done using a commercially available HDR and 192Ir radioactive sources.
| Study group | Role | What they receive |
|---|---|---|
| Lumpectomy with Brachytherapy | Experimental | Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient. Receives: Drug: Tamoxifen; Procedure: Lumpectomy; Radiation: brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Ipsilateral Breast Tumor Recurrence
Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.
Measured: 1 year after treatment
Number of Patients With Ipsilateral Breast Tumor Recurrence
Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.
Measured: 5 years after treatment
Secondary outcomes (6)
Percentage of Patients Who Experienced Complications
Complications to be measured include: breast tenderness/pain,reddening of the skin, bruising, formation of blood or fluid under the skin, skin ulceration, infection, discoloration of the skin, development of telangiectasia (spider veins), hardening of the breast tissue, and retraction of the breast tissue.
Measured: within 6 months of treatment
Percentage of Patients Who Experienced Complications
Complications to be measured include: breast tenderness/pain,reddening of the skin, bruising, formation of blood or fluid under the skin, skin ulceration, infection, discoloration of the skin, development of telangiectasia (spider veins), hardening of the breast tissue, and retraction of the breast tissue.
Measured: more than 6 months after treatment, for up to 5 years
Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent
The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: "0" representing an excellent result; "1" a good result; "2" a fair result; and "3" a poor result.
Measured: 6 months after treatment
Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent
The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: "0" representing an excellent result; "1" a good result; "2" a fair result; and "3" a poor result.
Measured: 12 months after treatment
Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent
The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: "0" representing an excellent result; "1" a good result; "2" a fair result; and "3" a poor result.
Measured: 6 months after treatment
Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent
The following items will be evaluated by comparing the treated breast with the untreated breast: overall cosmetic result; appearance of the surgical scar; breast size; breast shape; nipple position; and shape of areola. In scoring these items, a 4-point scale will be used, classifying the results into one of the following categories: "0" representing an excellent result; "1" a good result; "2" a fair result; and "3" a poor result.
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2006 (estimated)
- Study startDec 2002
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Unable to recruit further patients.
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.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Todd M. Tuttle, MD, Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00290654
- Sponsor's protocol ID
- 2002LS097
- Other IDs
- UMN-0211M35761
- Status last verified
- Dec 2017
- First submitted
- 9 Feb 2006
- Last updated
- 28 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Twin Cities Brachytherapy Study for Ductal Carcinoma in Situ A Phase II Trial
- ClinicalTrials.gov ID
- NCT00290654
- Acronym / sponsor ID
- 2002LS097
- Conditions
- Breast Cancer
- Keywords
- ductal breast carcinoma in situ, breast cancer in situ
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit further patients.
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Dec 2002
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Feb 2006 (estimated)
- Results
- Posted 15 May 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Internal radiation uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving internal radiation therapy using a special radiation therapy device may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying how well internal radiation therapy after lumpectomy works in treating women with ductal carcinoma in situ.
Detailed description
OBJECTIVES:
Primary
- Determine the ipsilateral breast tumor recurrence rate in women with ductal carcinoma in situ undergoing lumpectomy followed by brachytherapy using the MammoSite^® Radiation Therapy System.
Secondary
- Determine the early and late complication rates and cosmetic outcome in these patients after treatment.
OUTLINE: Patients undergo lumpectomy. Patients with negative tumor margins* (no ink on tumor) undergo placement of the MammoSite^® Radiation Therapy System at the time of lumpectomy or within 4 weeks after surgery.
NOTE: *If positive margins are present, the surgeon may elect to resect the positive margins and then insert a new MammoSite® device if all other eligibility criteria are met.
Beginning 2-5 days after placement of the MammoSite^®, patients undergo brachytherapy through the MammoSite^® twice daily for 5 days (a total of 10 fractions).
After completion of study treatment, patients are followed periodically for ≥ 5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lumpectomy with Brachytherapy | Experimental | Drug: Tamoxifen, Procedure: Lumpectomy, Radiation: brachytherapyPatients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Ductal carcinoma in situ (DCIS) confirmed by excisional or needle biopsy
- Size: < 3 cm on mammogram
- Unicentric disease
- Ability to place MammoSite device at time of lumpectomy or within 4 weeks of lumpectomy
- Patient Age: ≥ 18 years, no upper limit
Key exclusion criteria (4 listed)
- Prior history of cancer other than basal or squamous cell skin cancer or in situ cancer of the cervix
- Pregnant or breast feeding
- Multicentric disease
- Diagnosis of collagen vascular diseases, such as systemic lupus erythematosis, scleroderma, or dermatomyositis
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 |
|---|---|---|
| TamoxifenTamoxifen may be used postoperatively at the discretion of the treating physicians and patient | Drug | Lumpectomy with Brachytherapy |
| LumpectomyA standard lumpectomy will be performed with an attempt to remove at least 1 cm of gross margin around the DCIS. | Procedure or surgery | Lumpectomy with Brachytherapy |
| brachytherapyTreatment will be given in 10 fractions of 3.4 Gy per fraction twice a day, with a minimum of 6 hours between fractions. In general, brachytherapy will start between 2 - 5 days of implant. All treatments will be done using a commercially available HDR and 192Ir radioactive sources. | Radiation | Lumpectomy with Brachytherapy |
Primary outcome
Number of Patients With Ipsilateral Breast Tumor Recurrence
Time frame: 1 year after treatment
Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.
Number of Patients With Ipsilateral Breast Tumor Recurrence
Time frame: 5 years after treatment
Count of patients with early stage breast cancer who developed an ipsilateral breast tumor recurrence (IBTR) and failed after receiving breast-conserving therapy.
6 secondary outcomes
Percentage of Patients Who Experienced Complications
Time frame: within 6 months of treatment
Percentage of Patients Who Experienced Complications
Time frame: more than 6 months after treatment, for up to 5 years
Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent
Time frame: 6 months after treatment
Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent
Time frame: 12 months after treatment
Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent
Time frame: 6 months after treatment
Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent
Time frame: 12 months after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Todd M. Tuttle, MD principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tamoxifen, Lumpectomy and brachytherapy in people with Breast Cancer, run by Masonic Cancer Center, University of Minnesota 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 4 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 28 Dec 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 15 May 2015). 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?
Number of Patients With Ipsilateral Breast Tumor Recurrence (time frame: 1 year after treatment). 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 28 Dec 2017.