An interventional study of Mammosite ML and Mammosite ML in Breast Cancer and Ductal Carcinoma in Situ, sponsored by Mercy Research. Completed at 2 sites in United States. Open to female participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2021-07-15.
Sponsored by Mercy Research · Not applicable, Interventional, and Treatment
Among 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States — 31 open to participants now, 51 under way, 6 of them phase 3. Carcinoma, Intraductal, Noninfiltrating · United States.
Among the 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States, this one is the 133rd largest by enrollment of the 171 interventional ones, is one of 16 that started in 2009, is one of 65 with no phase, and was the 94th registered.
285 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 54 are open to participants now.
This study's enrollment of 20 is below the median of 66 across 207 interventional studies indexed under Carcinoma, Intraductal, Noninfiltrating.
Browse Carcinoma, Intraductal, Noninfiltrating studies →31 of the 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States are open now, in 3 countries. Each count lists the studies.
Of the 42 Carcinoma, Intraductal, Noninfiltrating studies recruiting now, 33 (79%) set no upper age limit and 5 (12%) stop at 75 or younger; 1 take children under 18; 4 take healthy volunteers.
This study: 45 Years and older · female · no healthy volunteers.
The full table on the hub →210 studies; the count open now beside each. This study's row is marked.
First in 1991; this study’s year is marked. 16 started in 2009.
Median enrollment 51 across the 171 interventional studies, 109 across the 38 observational. Of the 140 that completed or were terminated, 59 (42%) have results posted.
13 of 210 have an industry lead sponsor. The 10 most frequent:
Mercy Research is the lead sponsor of 17 studies on the registry; none are open to participants now.
Mercy Research has 1 study filed under Carcinoma, Intraductal, Noninfiltrating — fewer than ten, so there is no comparison to draw.
16 of the studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04722692Phase 3Uppsala UniversityDelayed Sentinel Lymph Node Biopsy in Ductal Cancer in Situ | 2026-12-30 |
| NCT05218044Glendale Adventist Medical Center d/b/a Adventist Health GlendaleCryoablation as a Minimally Invasive Alternative to Surgery for Managing Ductal Carcinoma In Situ | 2026-11-01 |
| NCT03546972M.D. Anderson Cancer CenterDiabetes Prevention Program With or Without Hunger Training in Helping to Lower Breast Cancer Risk in Obese Participants | 2026-11-30 |
| NCT03909282Stanford UniversitySurgical Excision vs Neoadjuvant Radiotherapy+Delayed Surgical Excision of Ductal Carcinoma | 2026-12 |
| NCT03448926PreludeDxThe PREDICT Registry: | 2026-12 |
Among the 210 studies in Carcinoma, Intraductal, Noninfiltrating with a site in United States, from their registry updates:
This study will evaluate the local control rate, cosmetic results, and complication rates of breast brachytherapy delivered using the MammoSite-ML® when used as the sole method of radiation therapy or as a boost technique for patients with stage I-II carcinoma of the breast (\< 3 cm), (non-lobular histology) treated with lumpectomy with histologically negative surgical margins by at least 2 mm, negative axillary lymph nodes, and DCIS.
Hypotheses:
285 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 54 are open to participants now.
This study's enrollment of 20 is below the median of 66 across 207 interventional studies indexed under Carcinoma, Intraductal, Noninfiltrating.
Browse Carcinoma, Intraductal, Noninfiltrating studies →Mercy Research is the lead sponsor of 17 studies on the registry; none are open to participants now.
Compared within Carcinoma, Intraductal, Noninfiltrating, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Breast Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS
Device: Mammosite ML
patients will be treated with HDR brachytherapy using Mammosite ML as a boost technique prior to standard external beam radiation after lumpectomy for breast cancer or DCIS
Device: Mammosite ML
34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days
Also known as: HDR Brachytherapy
5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx)
Also known as: HDR Brachytherapy
Ipsilateral Recurrence Rate
* Local recurrence is defined as either invasive or non-invasive breast cancer recurrence within the target volume. * Elsewhere recurrence is defined as either invasive or non-invasive breast cancer recurrence outside of the target volume. * Local control rate will be evaluated by imaging techniques, physical exam and biopsy, if applicable. Measured as a count of participants experiencing recurrence, i.e. each subject experiencing ipsilateral tumor recurrence within 5 years = 1, and each subject with no ipsilateral tumor recurrence within 5 years = 0
Time frame: 5 years
Cosmetic Results
Evaluation of cosmetic results as judged by the patient, surgeon, and radiation oncologist at stated follow up intervals. Serial photographs will be obtained. The cosmetic results will be assessed using the four category Harvard Scale definitions: Excellent - The treated breast looks essentially the same as the opposite breast Good - Minimal but identifiable effects of radiation on the treated breast Fair - Significant effects of radiation on the treated breast Poor - Severe normal tissue sequelae secondary to irradiation
Time frame: 6 months after treatment, then annually for 5 years
Toxicity Measured Through Adverse Event Incidence
The incidence of serious adverse events will be calculated. Adverse events reviewed for device harm/toxicity include skin redness, breast pain, infections, breast swelling, and rib fractures.
Time frame: during therapy, 6 weeks after completion of therapy, and additionally as needed
| Milestone | Sole Method | Boost |
|---|---|---|
| Started | 20 | 0 |
| Completed | 20 | 0 |
| Not completed | 0 | 0 |
* Local recurrence is defined as either invasive or non-invasive breast cancer recurrence within the target volume. * Elsewhere recurrence is defined as either invasive or non-invasive breast cancer recurrence outside of the target volume. * Local control rate will be evaluated by imaging techniques, physical exam and biopsy, if applicable. Measured as a count of participants experiencing recurrence, i.e. each subject experiencing ipsilateral tumor recurrence within 5 years = 1, and each subject with no ipsilateral tumor recurrence within 5 years = 0
| participants | Sole Method | Boost |
|---|---|---|
| Ipsilateral Recurrence Rate | 0 | — |
Evaluation of cosmetic results as judged by the patient, surgeon, and radiation oncologist at stated follow up intervals. Serial photographs will be obtained. The cosmetic results will be assessed using the four category Harvard Scale definitions: Excellent - The treated breast looks essentially the same as the opposite breast Good - Minimal but identifiable effects of radiation on the treated breast Fair - Significant effects of radiation on the treated breast Poor - Severe normal tissue sequelae secondary to irradiation
| Participants | Sole Method | Boost |
|---|---|---|
| Number of pts with "excellent" cosmetic results, 1 year post treatment | 4 | 0 |
| Number of pts with "good" cosmetic results, 1 year post treatment | 14 | 0 |
| Number of pts with "fair" cosmetic results, 1 year post treatment | 0 | 0 |
| Number of pts with "poor" cosmetic results, 1 year post treatment | 0 | 0 |
| Number of pts with "excellent" cosmetic results, 2 years post treatment | 4 | 0 |
| Number of pts with "good" cosmetic results, 2 years post treatment | 12 | 0 |
| Number of pts with "fair" cosmetic results, 2 years post treatment | 0 | 0 |
| Number of pts with "poor" cosmetic results, 2 years post treatment | 0 | 0 |
| Number of pts with "excellent" cosmetic results, 3 years post treatment | 4 | 0 |
| Number of pts with "good" cosmetic results, 3 years post treatment | 10 | 0 |
| Number of pts with "fair" cosmetic results, 3 years post treatment | 0 | 0 |
| Number of pts with "poor" cosmetic results, 3 years post treatment | 0 | 0 |
| Number of pts with "excellent" cosmetic results, 4 years post treatment | 4 | 0 |
| Number of pts with "good" cosmetic results, 4 years post treatment | 8 | 0 |
| Number of pts with "fair" cosmetic results, 4 years post treatment | 0 | 0 |
| Number of pts with "poor" cosmetic results, 4 years post treatment | 0 | 0 |
| Number of pts with "excellent" cosmetic results, 5 years post treatment | 3 | 0 |
| Number of pts with "good" cosmetic results, 5 years post treatment | 6 | 0 |
| Number of pts with "fair" cosmetic results, 5 years post treatment | 0 | 0 |
| Number of pts with "poor" cosmetic results, 5 years post treatment | 0 | 0 |
The incidence of serious adverse events will be calculated. Adverse events reviewed for device harm/toxicity include skin redness, breast pain, infections, breast swelling, and rib fractures.
| Participants | Sole Method | Boost |
|---|---|---|
| Toxicity Measured Through Adverse Event Incidence | 0 | 0 |
Collected over Adverse events will be collected during follow-up visits non-systematically over the course of 5 years beginning from procedure.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Sole Method | 0/20 (0%) | 0/20 (0%) | 1/20 (5%) |
| Boost | — | — | — |
| Event | Sole Method | Boost |
|---|---|---|
| CellulitisSkin and subcutaneous tissue disorders | 1/20 | — |
20 patients were enrolled within sole method arm, no patients were enrolled in boost method arm
| Age, Categorical(Participants) | Sole Method | Boost | Total |
|---|---|---|---|
| <=18 years | 0 | — | 0 |
| Between 18 and 65 years | 6 | — | 6 |
| >=65 years | 14 | — | 14 |
| Sex: Female, Male(Participants) | Sole Method | Boost | Total |
|---|---|---|---|
| Female | 20 | — | 20 |
| Male | 0 | — | 0 |
The record gives a start of Dec 2009, a primary completion of Dec 2015 and a completion of Apr 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2021, 5 years 7 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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Carcinoma, Intraductal, Noninfiltrating →
Mercy Research