Breast CancerPhase 2NCT01072838
Safety Study for Short-course Accelerated, Hypofractionated Partial Breast Radiotherapy (APBI) in Women With Early Stage Breast Cancer Using the Contura MLB
A Phase 2 study testing APBI (Dose Escalation) and Contura MLB Breast Brachytherapy Catheter in people with Breast Cancer, run by SenoRx, Inc. at 3 sites in United States.
Trial summary
To determine local disease control (recurrence) with shorter course of APBI delivered with a breast brachytherapy applicator. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- APBI (Dose Escalation) and Contura MLB Breast Brachytherapy Catheter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2009to Jun 2013
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Life expectancy > 10 years
- Lumpectomy with clear margins (negative per NSABP criteria)
- DCIS and/or invasive carcinoma
- If invasive, nodes must be negative
- T stage is Tis, T1 or T2<=3 cm max diameter
- ER(+) or ER(-)/PR(+)
Who cannot join
- Pregnant or breast feeding
- Active collagen-vascular disease
- Paget's disease of the breast
- Prior history of breast cancer
- Prior breast or thoracic radiotherapy
- Multicentric carcinoma
Show all 10Show fewer
- Synchronous bilateral breast cancer
- Surgical margins that cannot be assessed or that are positive
- T Stage is T2>3 cm or greater
- ER(-)/PR(-)
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903
Virginia Commonwealth University
Richmond, Virginia, 23298
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
Official title: Safety and Feasibility of Short-Course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial
To determine local disease control (recurrence) with shorter course of APBI delivered with a breast brachytherapy applicator.
- Conditions
- Breast Cancer
- Being tested
- APBI (Dose Escalation), Contura MLB Breast Brachytherapy Catheter
- Keywords
- breast cancer, APBI, brachytherapy, Contura
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APBI (Dose Escalation)Radiation
Accelerated, hypofractionated partial breast radiotherapy.
3 dose schemes followed for 6 months each.
Contura MLB Breast Brachytherapy CatheterDevice
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Other | Not described Receives: Radiation: APBI (Dose Escalation); Device: Contura MLB Breast Brachytherapy Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery of short-course APBI will result in locoregional disease control that is equal to that reported for conventional fractionation schemes for APBI.
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 posted22 Feb 2010 (estimated)
- Study startDec 2009
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- SenoRx, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- C. R. Bard
- Responsible party
- Sponsor
- Investigators
- Atif Khan, MD, Principal investigator, Rutgers Cancer Institute of New JerseyDouglas W. Arthur, MD, Principal investigator, Virginia Commonwealth UniversityMihai Ghilezan, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072838
- Sponsor's protocol ID
- S09-001
- Status last verified
- Jun 2013
- First submitted
- 18 Feb 2010
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
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
- Safety and Feasibility of Short-Course, Accelerated, Hypofractionated Partial Breast Radiotherapy in Women With Early Stage Breast Cancer Using the Contura MLB Breast Brachytherapy Catheter: A Phase II Trial
- ClinicalTrials.gov ID
- NCT01072838
- Acronym / sponsor ID
- S09-001
- Conditions
- Breast Cancer
- Keywords
- breast cancer, APBI, brachytherapy, Contura
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 60 participants (actual)
- Lead sponsor
- SenoRx, Inc.Industry (pharma, biotech, devices)
- Collaborators
- C. R. Bard
- Study start
- Dec 2009
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 22 Feb 2010 (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.
To determine local disease control (recurrence) with shorter course of APBI delivered with a breast brachytherapy applicator.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Other | Radiation: APBI (Dose Escalation), Device: Contura MLB Breast Brachytherapy Catheter |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Life expectancy > 10 years
- Lumpectomy with clear margins (negative per NSABP criteria)
- DCIS and/or invasive carcinoma
- If invasive, nodes must be negative
- T stage is Tis, T1 or T2<=3 cm max diameter
Key exclusion criteria (10 listed)
- Pregnant or breast feeding
- Active collagen-vascular disease
- Paget's disease of the breast
- Prior history of breast cancer
- Prior breast or thoracic radiotherapy
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 |
|---|---|---|
| APBI (Dose Escalation)Accelerated, hypofractionated partial breast radiotherapy. 3 dose schemes followed for 6 months each. | Radiation | Dose Escalation |
| Contura MLB Breast Brachytherapy Catheter | Device | Dose Escalation |
Primary outcome
Delivery of short-course APBI will result in locoregional disease control that is equal to that reported for conventional fractionation schemes for APBI.
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.
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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.
Atif Khan, MD principal investigator
Rutgers Cancer Institute of New Jersey
Douglas W. Arthur, MD principal investigator
Virginia Commonwealth University
Mihai Ghilezan, MD principal investigator
Corewell Health East
3 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 APBI (Dose Escalation) and Contura MLB Breast Brachytherapy Catheter in people with Breast Cancer, run by SenoRx, Inc. at 3 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 6 inclusion and 10 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 3 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?
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?
Delivery of short-course APBI will result in locoregional disease control that is equal to that reported for conventional fractionation schemes for APBI. (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 17 Jun 2013.