Trial · NCT00290654
Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ
NCT00290654, Phase 2, Terminated, Masonic Cancer Center, University of Minnesota; results first posted 2015-05-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ. Trials, record NCT00290654. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00290654
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Internal Radiation Therapy After Lumpectomy in Treating Women With Ductal Carcinoma in Situ
- NCT number
- NCT00290654
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 45 participants, actual
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Conditions
- Breast Cancer
- Interventions
- Tamoxifen, Lumpectomy, brachytherapy
- First posted
- 2006-02-13
- Last updated
- 2017-12-28
- Results first posted
- 2015-05-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Patients With Ipsilateral Breast Tumor Recurrence | 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. |
| Primary | Number of Patients With Ipsilateral Breast Tumor Recurrence | 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. |
| Secondary | Percentage of Patients Who Experienced Complications | within 6 months of treatment | 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. |
| Secondary | Percentage of Patients Who Experienced Complications | more than 6 months after treatment, for up to 5 years | 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. |
| Secondary | Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent | 6 months after treatment | 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. |
| Secondary | Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent | 12 months after treatment | 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. |
| Secondary | Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent | 6 months after treatment | 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. |
| Secondary | Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent | 12 months after treatment | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Patients With Ipsilateral Breast Tumor Recurrence | 1 year after treatment | participants | NUMBER | |
| PRIMARY | Number of Patients With Ipsilateral Breast Tumor Recurrence | 5 years after treatment | participants | NUMBER | |
| SECONDARY | Percentage of Patients Who Experienced Complications | within 6 months of treatment | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Patients Who Experienced Complications | more than 6 months after treatment, for up to 5 years | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent | 6 months after treatment | percentage of physicians | NUMBER | |
| SECONDARY | Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent | 12 months after treatment | percentage of physicians | NUMBER | |
| SECONDARY | Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent | 6 months after treatment | percentage of participants | NUMBER | |
| SECONDARY | Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent | 12 months after treatment | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Patients With Ipsilateral Breast Tumor Recurrence | Evaluable Patients | 0 | participants | ||
| Number of Patients With Ipsilateral Breast Tumor Recurrence | Evaluable Patients | 4 | participants | ||
| Percentage of Patients Who Experienced Complications | Evaluable Patients | 65.8 | percentage of participants | ||
| Percentage of Patients Who Experienced Complications | Evaluable Patients | 24.4 | percentage of participants | ||
| Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent | Evaluable Patients | 100 | percentage of physicians | ||
| Percentage of Physicians Judging the Cosmetic Outcome as Good or Excellent | Evaluable Patients | 86.7 | percentage of physicians | ||
| Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent | Evaluable Patients | 96.8 | percentage of participants | ||
| Percentage of Patients Judging the Cosmetic Outcome as Good or Excellent | Evaluable Patients | 92.3 | percentage of participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MammoSite Treatment Group | 41 | |
| Overall Study | COMPLETED | MammoSite Treatment Group | 41 | |
| Overall Study | NOT COMPLETED | MammoSite Treatment Group | 0 |
Source ClinicalTrials.gov
Adverse events9
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Breast tenderness/pain - early onset | Injury, poisoning and procedural complications | MammoSite Treatment Group | 11 | 41 | |
| other | Breast tenderness/pain - late onset | Injury, poisoning and procedural complications | MammoSite Treatment Group | 4 | 41 | |
| other | Erythema - early onset | Injury, poisoning and procedural complications | MammoSite Treatment Group | 11 | 41 | |
| other | Hematoma/seroma - early onset | Injury, poisoning and procedural complications | MammoSite Treatment Group | 5 | 41 | |
| other | Infection - early onset | Infections and infestations | MammoSite Treatment Group | 4 | 41 | |
| other | Pigmentation - early onset | Skin and subcutaneous tissue disorders | MammoSite Treatment Group | 8 | 41 | |
| other | Telangiectasia - late onset | Skin and subcutaneous tissue disorders | MammoSite Treatment Group | 4 | 41 | |
| other | Induration - early onset | Skin and subcutaneous tissue disorders | MammoSite Treatment Group | 6 | 41 | |
| serious | Skin ulceration | Skin and subcutaneous tissue disorders | MammoSite Treatment Group | 1 | 41 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MammoSite Treatment Group | ||
| Total, other adverse events | MammoSite Treatment Group | 28 | 41 |
| Total, serious adverse events | MammoSite Treatment Group | 1 | 41 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00290654
GET https://conductscience.org/api/trials/v1/NCT00290654/registered