DCISPhase 2DCISNCT00586326
MammoSite as Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ
A Phase 2 study testing MammoSite Radiation Therapy System in people with DCIS, run by Hologic, Inc. at 12 sites in United States.
Trial summary
This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS. Read more about this study
- Who is it for?
- Ages 45 years and older, women only
- Conditions the study is for
- DCIS
- What is being tested?
- MammoSite Radiation Therapy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 12 sitesUnited States
- Study dates
- Aug 2003to Apr 2011
- 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 45 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-Surgery:
- Unicentric pure DCIS
- Lesions should have a greatest dimension of 3 cm or less as determined by pre-surgery mammography and MRI
- Post-Surgery:
- Negative histological margins confirmed prior to beginning radiation therapy.
- Margins are positive if there is tumor at the inked margin.
- Classified as low (NG1), intermediate (NG2) or high (NG3) nuclear grade DCIS, using the Philadelphia Consensus Conference Guidelines are eligible
- Clinically node negative
Who cannot join
- Distance from the balloon surface to the surface of the skin < 5mm as determined by CT imaging.
- Distant metastases.
- Invasive or in-situ lobular carcinoma (post-surgery assessment).
- Nonepithelial breast malignancies such as sarcoma or lymphoma.
- DCIS that is multicentric in the ipsilateral breast.
- Pregnant or lactating.
Show all 14Show fewer
- Prior non-hormonal therapy for the present breast cancer, including radiation therapy and/or chemotherapy.
- Collagen vascular diseases
- Coexisting medical conditions with life expectancy < 2 years.
- Serious psychiatric or addictive disorder
- Previously treated contralateral breast carcinoma
- Synchronous bilateral breast carcinoma.
- Other malignancy, except non-melanoma skin cancer, < 5 years prior to participation in the study; the disease free interval from any prior carcinoma must be continuous.
- Patients with diffuse disease
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites
St. Agnes Hospital
Baltimore, Maryland, 21229
MD Anderson Cancer Clinic
Houston, Texas, 77030
Daniel Freeman Hospital
Inglewood, California, 90301
University of Southern California
Los Angeles, California, 90033
Cedars Medical Center
Miami Beach, Florida, 33136
NY Presbyterian
New York, New York, 10065
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Arizona Oncology Services
Phoenix, Arizona, 85032
Rhode Island Hospital
Providence, Rhode Island, 02903
Virginia Commonwealth University
Richmond, Virginia, 23298
William Beaumont Hospital
Royal Oak, Michigan, 48073
Swedish Cancer Institute
Seattle, Washington, 98104
About this study
Official title: MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)
This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.
Read the detailed description
Data relevant to the evaluation of the efficacy and safety of the MammoSite RTS system in providing radiation therapy to patients with DCIS will be collected. The MammoSite is a radionuclide applicator designed to deliver internal radiation therapy (brachytherapy) in patients with breast tumors following breast tumor resection surgery (lumpectomy).
- Conditions
- DCIS
- Being tested
- MammoSite Radiation Therapy System
- Keywords
- MammoSite, DCIS
- Medical subject headings
- Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MammoSite Radiation Therapy SystemDevice
The MammoSite is a balloon catheter that is designed to position a radioactive source inside the lumpectomy cavity. The MammoSite applicator is inserted into the cavity created by the tumor removal surgery. The MammoSite applicator is then inflated and expands to fill the cavity.
| Study group | Role | What they receive |
|---|---|---|
| Women with DCIS | Experimental | Women with DCIS Receives: Device: MammoSite Radiation Therapy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Local Control Rate for Follow-up Period of 5 Years.
Failure of local control was defined as a histologically confirmed recurrence (invasive or non-invasive) within the prescription isodose volume. All recurrences were to have histological evaluation per the protocol; however, the case report forms did not provide space for this data to be captured. Ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrence or distant metastases were not considered treatment failures unless accompanied by ipsilateral breast failure.
Measured: Data collected at the time of implant, radiation therapy, and at the patient's 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year follow-up visits.
Secondary outcomes (4)
Overall Survival
Measured: At 5 Years
Cause Specific Survival
Measured: At 5 Years
Disease Free Survival
Measured: At 5 Years
Cosmetic Evaluations Over Time
As assessed using the four category Harvard Scale for subjects with an evaluation at the 5 year timepoint
Measured: At 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startAug 2003
- Primary completionJan 2006
- Study completionApr 2011
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 DCISStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Southern California
- Responsible party
- Sponsor
- Investigators
- Oscar Streeter, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586326
- Sponsor's protocol ID
- MS-700
- Acronym
- DCIS
- Status last verified
- Nov 2012
- First submitted
- 21 Dec 2007
- Last updated
- 6 Nov 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MammoSite Radiation Therapy System (RTS) as the Sole Radiation Therapy Technique for Ductal Carcinoma In-Situ (DCIS)
- ClinicalTrials.gov ID
- NCT00586326
- Acronym / sponsor ID
- DCIS / MS-700
- Conditions
- DCIS
- Keywords
- MammoSite, DCIS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Southern California
- Study start
- Aug 2003
- Primary completion
- Jan 2006 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 4 Jan 2008 (estimated)
- Results
- Posted 22 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study has been designed to compile information on the efficacy of the MammoSite RTS providing sole radiation therapy for patients with pure DCIS.
Detailed description
Data relevant to the evaluation of the efficacy and safety of the MammoSite RTS system in providing radiation therapy to patients with DCIS will be collected. The MammoSite is a radionuclide applicator designed to deliver internal radiation therapy (brachytherapy) in patients with breast tumors following breast tumor resection surgery (lumpectomy).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with DCIS | Experimental | Device: MammoSite Radiation Therapy SystemWomen with DCIS |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pre-Surgery:
- Post-Surgery:
Key exclusion criteria (14 listed)
- Distance from the balloon surface to the surface of the skin < 5mm as determined by CT imaging.
- Distant metastases.
- Invasive or in-situ lobular carcinoma (post-surgery assessment).
- Nonepithelial breast malignancies such as sarcoma or lymphoma.
- DCIS that is multicentric in the ipsilateral breast.
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 Radiation Therapy SystemThe MammoSite is a balloon catheter that is designed to position a radioactive source inside the lumpectomy cavity. The MammoSite applicator is inserted into the cavity created by the tumor removal surgery. The MammoSite applicator is then inflated and expands to fill the cavity. | Device | Women with DCIS |
Primary outcome
Local Control Rate for Follow-up Period of 5 Years.
Time frame: Data collected at the time of implant, radiation therapy, and at the patient's 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year follow-up visits.
Failure of local control was defined as a histologically confirmed recurrence (invasive or non-invasive) within the prescription isodose volume. All recurrences were to have histological evaluation per the protocol; however, the case report forms did not provide space for this data to be captured. Ipsilateral axillary, infraclavicular, internal mammary, or supraclavicular recurrence or distant metastases were not considered treatment failures unless accompanied by ipsilateral breast failure.
4 secondary outcomes
Overall Survival
Time frame: At 5 Years
Cause Specific Survival
Time frame: At 5 Years
Disease Free Survival
Time frame: At 5 Years
Cosmetic Evaluations Over Time
Time frame: At 5 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2012.
- 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.
Oscar Streeter, MD principal investigator
University of Southern California
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MammoSite Radiation Therapy System in people with DCIS, run by Hologic, Inc. at 12 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 8 inclusion and 14 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 6 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 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.
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 22 Oct 2012). 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?
Local Control Rate for Follow-up Period of 5 Years. (time frame: Data collected at the time of implant, radiation therapy, and at the patient's 3 month, 6 month, 1 year, 2 year, 3 year, 4 year and 5 year follow-up visits.). 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 6 Nov 2012.