Breast CancerMammosite MLNCT01448447
Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml®
A study testing Mammosite ML in people with Breast Cancer and Ductal Carcinoma in Situ, run by Mercy Research at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- Breast Cancer, Ductal Carcinoma in Situ
- What is being tested?
- Mammosite ML
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2009to Apr 2016
- Phase
- Interventional
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women,age of at least 45 years
- Zubrod performance status of 0-2
- AJCC Stage I-II (T1-T2, N0 M0) breast cancer
- Maximum tumor dimension < 3 cm
- Invasive ductal, medullary, papillary, tubular, colloid (mucinous) histologies
- Unifocal breast cancer
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- Unilateral breast cancer (no synchronous or previous contralateral breast cancer)
- Lumpectomy with negative surgical margins by at least 2 mm or re-excision specimen with negative surgical margins by at least 2 mm
- Ductal Carcinoma In-Situ
- Negative axillary lymph nodes for invasive breast cancer (sentinel node biopsy or standard level I-II dissection with > 6 nodes removed)
- Time interval from final breast surgery to brachytherapy loading less than 8 weeks
- At least 2 mm of breast tissue between the skin and the MammoSite® balloon surface(prefer > 5 mm)
- If chemotherapy is planned, it must begin no earlier that 2 weeks following completion of radiation therapy. If chemotherapy is first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation therapy.
- Signed study-specific consent form
Who cannot join
- Invasive lobular histology
- Non-epithelial breast malignancies such as sarcoma or lymphoma
- Multifocal or multicentric invasive carcinoma
- Extensive intraductal component (EIC)
- Paget's disease of the nipple
- Skin involvement by tumor, regardless of tumor size
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- Positive axillary lymph nodes
- Distant metastases
- Collagen vascular disease (scleroderma)
- Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females (negative pregnancy test for women of child-bearing age)
- Any previously treated or synchronous contralateral breast carcinoma
- Patients with psychiatric or addictive disorder that would preclude obtaining informed Consent
- Men
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mercy Clinic St. Louis Cancer and Breast Institute
St Louis, Missouri, 63011
Mercy Hospital St. Louis
St Louis, Missouri, 63141
About this study
Official title: Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml® Radiation Therapy Delivery System as the Sole Method of Radiation Therapy or as a Boost for Early Stage Breast Cancer and Ductal Carcinoma In Situ of the Breast
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:
- For selected patients with stage I breast carcinoma and Ductal Carcinoma In Situ (DCIS), radiation therapy delivered with brachytherapy alone using the MammoSite-ML® is technically feasible and reproducible with acceptable complication rates.
- Cosmetic results after brachytherapy will be similar to that obtained after traditional whole breast external beam radiation therapy.
- Local tumor control rate in the breast after brachytherapy will be similar to that of conventional external beam radiation therapy, with less inconvenience and potentially less cost to the patient, given the selection criteria which minimize the risk of clinically significant multicentric or extensive residual carcinoma following lumpectomy.
- Conditions
- Breast Cancer, Ductal Carcinoma in Situ
- Being tested
- Mammosite ML
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mammosite MLDevice
Also called HDR Brachytherapy
34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days
Mammosite MLDevice
Also called 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)
| Study group | Role | What they receive |
|---|---|---|
| Sole method | Experimental | patients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS Receives: Device: Mammosite ML |
| Boost | Experimental | 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 Receives: Device: Mammosite ML |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 5 years
Secondary outcomes (2)
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
Measured: 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.
Measured: during therapy, 6 weeks after completion of therapy, and additionally as needed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2011 (estimated)
- Study startDec 2009
- Primary completionDec 2015
- Study completionApr 2016
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mercy Research
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Frazier, MD, Mercy Research
- Investigators
- Bethany G Sleckman, MD, Principal investigator, Mercy Hospital St. Louis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01448447
- Sponsor's protocol ID
- Mammosite ML
- Acronym
- Mammosite ML
- Status last verified
- Jun 2021
- First submitted
- 30 Sep 2011
- Last updated
- 15 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Trial to Evaluate Breast Brachytherapy Using the Mammosite-Ml® Radiation Therapy Delivery System as the Sole Method of Radiation Therapy or as a Boost for Early Stage Breast Cancer and Ductal Carcinoma In Situ of the Breast
- ClinicalTrials.gov ID
- NCT01448447
- Acronym / sponsor ID
- Mammosite ML / Mammosite ML
- Conditions
- Breast Cancer, Ductal Carcinoma in Situ
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Mercy ResearchUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 7 Oct 2011 (estimated)
- Results
- Posted 15 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- For selected patients with stage I breast carcinoma and Ductal Carcinoma In Situ (DCIS), radiation therapy delivered with brachytherapy alone using the MammoSite-ML® is technically feasible and reproducible with acceptable complication rates.
- Cosmetic results after brachytherapy will be similar to that obtained after traditional whole breast external beam radiation therapy.
- Local tumor control rate in the breast after brachytherapy will be similar to that of conventional external beam radiation therapy, with less inconvenience and potentially less cost to the patient, given the selection criteria which minimize the risk of clinically significant multicentric or extensive residual carcinoma following lumpectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sole method | Experimental | Device: Mammosite MLpatients will be treated with HDR brachytherapy using Mammosite ML as the sole method for radiation delivery after lumpectomy for breast cancer or DCIS |
| Boost | Experimental | Device: Mammosite MLpatients 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 |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Women,age of at least 45 years
- Zubrod performance status of 0-2
- AJCC Stage I-II (T1-T2, N0 M0) breast cancer
- Maximum tumor dimension < 3 cm
- Invasive ductal, medullary, papillary, tubular, colloid (mucinous) histologies
Key exclusion criteria (13 listed)
- Invasive lobular histology
- Non-epithelial breast malignancies such as sarcoma or lymphoma
- Multifocal or multicentric invasive carcinoma
- Extensive intraductal component (EIC)
- Paget's disease of the nipple
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 |
|---|---|---|
| Mammosite MLAlso: HDR Brachytherapy34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days | Device | Sole method |
| Mammosite MLAlso: HDR Brachytherapy5-10.2 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) | Device | Boost |
Primary outcome
Ipsilateral Recurrence Rate
Time frame: 5 years
* 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
2 secondary outcomes
Cosmetic Results
Time frame: 6 months after treatment, then annually for 5 years
Toxicity Measured Through Adverse Event Incidence
Time frame: during therapy, 6 weeks after completion of therapy, and additionally as needed
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- 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.
Bethany G Sleckman, MD principal investigator
Mercy Hospital St. Louis
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mammosite ML in people with Breast Cancer and Ductal Carcinoma in Situ, run by Mercy Research at 2 sites 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 14 inclusion and 13 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 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 15 Jul 2021). 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?
Ipsilateral Recurrence Rate (time frame: 5 years). 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 15 Jul 2021.