Breast CancerPhase 2NCT00214149
Multi-catheter High Dose Rate (HDR) Breast Brachytherapy
A Phase 2 study testing brachytherapy in people with Breast Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ (DCIS). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- brachytherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Oct 2010
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invasive breast cancer or DCIS, tumor stage of Tis, T1, T2 if lesion is < 3 cm, N0 or N1 if 1-3 + nodes with no extracapsular extension
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792
About this study
Official title: A UW Phase II Trial of Multi-catheter HDR Brachytherapy Following Lumpectomy for Early Stage Breast Breast Cancer
Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ (DCIS). Despite superior cosmetic outcome, BCT is more complex and requires a protracted treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole breast. The purpose of this study is to determine if an acceptable outcome can be achieved with radiation delivered only to the region of the tumor bed. If this is true, partial breast irradiation may lend itself to much shorter treatment times (one week) and the toxicities to adjacent normal structures (heart, lung, chest wall) will be greatly reduced.
- Conditions
- Breast Cancer
- Being tested
- 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.
brachytherapyRadiation
breast brachytherapy to 34 Gy
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | breast brachytherapy to a dose of 34 Gy Receives: Radiation: brachytherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
To Determine if Brachytherapy Will Produce Non-inferior Local Regional Control at 5 Years Post Treatment When Compared to Historical Results of Conventional XRT
Measured: 5 years
Secondary outcomes (1)
To Determine if Brachytherapy Will Produce Non-inferior Toxicity to XRT at 3 Years
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startOct 2004
- Primary completionApr 2008
- Study completionOct 2010
Why it stopped: lost funding
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rakesh Patel, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00214149
- Sponsor's protocol ID
- RO04102
- Other IDs
- 2004-0268
- Status last verified
- Oct 2018
- First submitted
- 13 Sep 2005
- Last updated
- 5 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
McHaffie DR, Patel RR, Adkison JB, Das RK, Geye HM, Cannon GM. Outcomes after accelerated partial breast irradiation in patients with ASTRO consensus statement cautionary features. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):46-51. doi: 10.1016/j.ijrobp.2010.05.011. Epub 2010 Aug 21.
PubMed 20732760
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A UW Phase II Trial of Multi-catheter HDR Brachytherapy Following Lumpectomy for Early Stage Breast Breast Cancer
- ClinicalTrials.gov ID
- NCT00214149
- Acronym / sponsor ID
- RO04102
- Conditions
- Breast Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: lost funding
- Enrolment
- 127 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Apr 2008 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 21 Sep 2005 (estimated)
- Results
- Posted 5 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Breast conservation therapy (BCT) is now widely accepted as a treatment option for most women with Stage I and II invasive breast cancer and most patients with ductal carcinoma in situ (DCIS). Despite superior cosmetic outcome, BCT is more complex and requires a protracted treatment regimen comprised of 6 weeks of daily external beam radiation therapy to the whole breast. The purpose of this study is to determine if an acceptable outcome can be achieved with radiation delivered only to the region of the tumor bed. If this is true, partial breast irradiation may lend itself to much shorter treatment times (one week) and the toxicities to adjacent normal structures (heart, lung, chest wall) will be greatly reduced.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Radiation: brachytherapybreast brachytherapy to a dose of 34 Gy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Invasive breast cancer or DCIS, tumor stage of Tis, T1, T2 if lesion is < 3 cm, N0 or N1 if 1-3 + nodes with no extracapsular extension
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| brachytherapybreast brachytherapy to 34 Gy | Radiation | 1 |
Primary outcome
To Determine if Brachytherapy Will Produce Non-inferior Local Regional Control at 5 Years Post Treatment When Compared to Historical Results of Conventional XRT
Time frame: 5 years
1 secondary outcome
To Determine if Brachytherapy Will Produce Non-inferior Toxicity to XRT at 3 Years
Time frame: 3 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20732760McHaffie DR, Patel RR, Adkison JB, Das RK, Geye HM, Cannon GM. Outcomes after accelerated partial breast irradiation in patients with ASTRO consensus statement cautionary features. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):46-51. doi: 10.1016/j.ijrobp.2010.05.011. Epub 2010 Aug 21.
Related trials for Breast Cancer
Not yet recruiting
Effect of a Health Belief Model Based Digital Nudge Intervention on Breast Cancer Screening
Breast Cancer Screening, Breast Cancer Awareness
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Not yet recruitingPhase 2
Low-Dose Apatinib Plus Chemotherapy in ADC-Pretreated HER2-Positive and HER2-Low Advanced Breast Cancer
Breast Neoplasms, Advanced Breast Cancer
RecruitingPhase 3
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
Breast Neoplasms
Active, not recruitingPhase 2
Phase II Study of Dato-DXd in Triple-negative Breast Cancer Patients With Newly Diagnosed or Progressing Brain Metastases
Breast Cancer Stage IV
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.
Rakesh Patel, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing brachytherapy in people with Breast Cancer, run by University of Wisconsin, Madison 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 1 inclusion and 0 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 5 Nov 2018. 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 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 5 Nov 2018). 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?
To Determine if Brachytherapy Will Produce Non-inferior Local Regional Control at 5 Years Post Treatment When Compared to Historical Results of Conventional XRT (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 NCT00214149, 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 5 Nov 2018.