Breast CancerPhase 4NCT00699101
Using the Conture® Multi-Lumen Balloon to Deliver Accelerated Partial Breast Brachytherapy
A Phase 4 study testing Conture Multi-Lumen Balloon in people with Breast Cancer, run by SenoRx, Inc. at 1 site in United States.
Trial summary
This multiple site, prospective, non-randomized study has been designed to compile information on the efficacy of the Contura™ MLB in delivering APBI in appropriately selected patients through evaluation of dosimetric success as compared with a single central lumen balloon device and through treatment outcomes. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Conture Multi-Lumen Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 342 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Jun 2013
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Able and willing to sign informed consent
- Age 50 or older at diagnosis
- Life expectancy greater than 10 years (excluding diagnosis of breast cancer).
- Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (negative surgical margins per NSABP criteria).
- On histologic examination, the tumor must be DCIS or invasive breast carcinoma. For patients with invasive breast cancer, an axillary staging procedure must be performed. Either:
- sentinel node biopsy (SNB) alone if sentinel node(s) is/are negative; or
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- axillary dissection (minimum of six axillary nodes removed); and
- the axillary node(s) must be pathologically negative.
- The T stage must be Tis, T1, or T2. If T2, the tumor must be ≤ 3.0 cm in maximum diameter.
- Estrogen receptor positive tumor
Who cannot join
- Age < 50 at diagnosis (regardless of histology)
- Pregnant or breast-feeding (if appropriate, patient must use birth control during the study)
- Active collagen-vascular disease
- Paget's disease of the breast
- History of DCIS or invasive breast cancer
- Prior breast or thoracic RT for any condition
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- Multicentric carcinoma (DCIS or invasive)
- Synchronous bilateral invasive or non-invasive breast cancer
- Surgical margins that cannot be microscopically assessed or that are positive or close
- Positive axillary node(s)
- T stage of T2 with the tumor > 3 cm in maximum diameter or a T stage > 3
- Estrogen receptor negative tumor
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298-0058
About this study
Official title: A Multi-site Prospective, Non Randomized Study Utilizing the Conture® Multi-Lumen Balloon (MLB) Breast Brachytherapy Applicator to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetric Success, Local Tumor Control, Cosmetic Outcome, Acute and Chronic Toxicity, and Clinical Scenarios for Optimal Use
This multiple site, prospective, non-randomized study has been designed to compile information on the efficacy of the Contura™ MLB in delivering APBI in appropriately selected patients through evaluation of dosimetric success as compared with a single central lumen balloon device and through treatment outcomes.
Read the detailed description
Data collected during this study will include baseline patient demographics, information related to the time of implant, radiation therapy details, and removal of the device as well as recurrence data, cosmetic outcomes and toxicities. The patient's follow-up data will be collected during the patient's standard follow-up visits.
- Conditions
- Breast Cancer
- Being tested
- Conture Multi-Lumen Balloon
- Keywords
- Breast Cancer, Conture®, Brachytherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conture Multi-Lumen BalloonDevice
Placement of the balloon in a separate procedure using ultrasound guidance after surgery for breast cancer.
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Conture Multi-Lumen Balloon Receives: Device: Conture Multi-Lumen Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device.
Measured: 5 years
Secondary outcomes (1)
Quantify the dosimetric improvement of multi-lumen use over single lumen use through dosimetric comparison.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionMar 2011
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 342 participants (actual)
Sponsor and investigators
- Lead sponsor
- SenoRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- C. R. Bard
- Responsible party
- Sponsor
- Investigators
- Douglas W. Arthur, MD, Study chair, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00699101
- Sponsor's protocol ID
- SENORX-S07-002
- Status last verified
- Jun 2013
- First submitted
- 12 Jun 2008
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cuttino LW, Arthur DW, Vicini F, Todor D, Julian T, Mukhopadhyay N. Long-term results from the Contura multilumen balloon breast brachytherapy catheter phase 4 registry trial. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1025-9. doi: 10.1016/j.ijrobp.2014.08.341. Epub 2014 Oct 13.
PubMed 25442036
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-site Prospective, Non Randomized Study Utilizing the Conture® Multi-Lumen Balloon (MLB) Breast Brachytherapy Applicator to Deliver Accelerated Partial Breast Irradiation: Analysis of Dosimetric Success, Local Tumor Control, Cosmetic Outcome, Acute and Chronic Toxicity, and Clinical Scenarios for Optimal Use
- ClinicalTrials.gov ID
- NCT00699101
- Acronym / sponsor ID
- SENORX-S07-002
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Conture®, Brachytherapy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 342 participants (actual)
- Lead sponsor
- SenoRx, Inc.Industry (pharma, biotech, devices)
- Collaborators
- C. R. Bard
- Study start
- Jun 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 17 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This multiple site, prospective, non-randomized study has been designed to compile information on the efficacy of the Contura™ MLB in delivering APBI in appropriately selected patients through evaluation of dosimetric success as compared with a single central lumen balloon device and through treatment outcomes.
Detailed description
Data collected during this study will include baseline patient demographics, information related to the time of implant, radiation therapy details, and removal of the device as well as recurrence data, cosmetic outcomes and toxicities. The patient's follow-up data will be collected during the patient's standard follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Device: Conture Multi-Lumen BalloonConture Multi-Lumen Balloon |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able and willing to sign informed consent
- Age 50 or older at diagnosis
- Life expectancy greater than 10 years (excluding diagnosis of breast cancer).
- Surgical treatment of the breast must have been lumpectomy. The margins of the resected specimen must be histologically free of tumor (negative surgical margins per NSABP criteria).
- On histologic examination, the tumor must be DCIS or invasive breast carcinoma. For patients with invasive breast cancer, an axillary staging procedure must be performed. Either:
Key exclusion criteria (12 listed)
- Age < 50 at diagnosis (regardless of histology)
- Pregnant or breast-feeding (if appropriate, patient must use birth control during the study)
- Active collagen-vascular disease
- Paget's disease of the breast
- History of DCIS or invasive breast cancer
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 |
|---|---|---|
| Conture Multi-Lumen BalloonPlacement of the balloon in a separate procedure using ultrasound guidance after surgery for breast cancer. | Device | A |
Primary outcome
Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device.
Time frame: 5 years
1 secondary outcome
Quantify the dosimetric improvement of multi-lumen use over single lumen use through dosimetric comparison.
Time frame: 5 years
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
- Derived from this study: PubMed 25442036Cuttino LW, Arthur DW, Vicini F, Todor D, Julian T, Mukhopadhyay N. Long-term results from the Contura multilumen balloon breast brachytherapy catheter phase 4 registry trial. Int J Radiat Oncol Biol Phys. 2014 Dec 1;90(5):1025-9. doi: 10.1016/j.ijrobp.2014.08.341. Epub 2014 Oct 13.
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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.
Douglas W. Arthur, MD study chair
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Conture Multi-Lumen Balloon in people with Breast Cancer, run by SenoRx, Inc. 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 10 inclusion and 12 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 17 Jun 2013. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
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?
Dosimetric efficacy of the Contura™ MLB with the historical efficacy rate of a single central lumen balloon device. (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00699101, which also lists 1 linked publication.
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 17 Jun 2013.