Breast CancerPhase 4NCT00872859
The BREASTrial:Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
A Phase 4 study testing Implantation of Dermal Matrix substitute in people with Breast Cancer and Reconstructive Surgery, run by University of Utah at 1 site in United States.
Trial summary
Primary Hypothesis: 1. Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction Secondary hypotheses: 1. The complication rates following staged breast reconstruction using Alloderm or Dermamatrix are higher if the patient requires radiation compared to those who do not… Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Reconstructive Surgery
- What is being tested?
- Implantation of Dermal Matrix substitute
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2008to Feb 2015
- 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 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Plan for immediate temporary breast reconstruction with tissue expander placement and acellular dermal matrix in patients undergoing mastectomy
- Female gender
- Age between 18 and 80
- Consent to participate in the study
Who cannot join
- Patients not undergoing breast reconstruction following mastectomy
- Patients undergoing delayed breast reconstruction following mastectomy
- Patients undergoing immediate definitive breast reconstruction after mastectomy
- Patients requiring definitive reconstruction within 3 months of immediate temporary breast reconstruction
- Medical debility precluding surgical treatment
- Prior breast or chest wall irradiation
- Pregnant patients
- Male gender
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Utah Hospital/ Huntsman Cancer Institute
Salt Lake City, Utah, 84112
About this study
Official title: The BREASTrial: Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
Primary Hypothesis:
- Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction
Read more
Secondary hypotheses:
- The complication rates following staged breast reconstruction using Alloderm or Dermamatrix are higher if the patient requires radiation compared to those who do not require radiation.
- Dermal matrix incorporation is not altered in patients requiring radiation compared to those who do not require radiation.
- Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix
Specific aims:
- Evaluate the complication rates in women undergoing staged breast reconstruction with acellular dermal matrix with or without radiation
- Compare the complication rates between the two types of acellular dermal matrix
- Evaluate the histologic characteristics of the dermal matrix exposed to radiation compared to that not exposed to radiation.
- Compare the rates of incorporation of the dermal substance into surrounding tissues of those patients undergoing radiation to those not undergoing radiation
- Conditions
- Breast Cancer, Reconstructive Surgery
- Being tested
- Implantation of Dermal Matrix substitute
- Keywords
- Breast Cancer, Cancer of Breast, Reconstructive Surgery
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantation of Dermal Matrix substituteProcedure or surgery
Also called Dermamatrix, Alloderm, Dermal Matrix
Dermal Matrix implanted in post mastectomy pts at time of mastectomy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dermamatrix with radiation Receives: Procedure: Implantation of Dermal Matrix substitute |
| 2 | Experimental | Dermamatrix without radiation Receives: Procedure: Implantation of Dermal Matrix substitute |
| 3 | Experimental | Alloderm with radiation Receives: Procedure: Implantation of Dermal Matrix substitute |
| 4 | Experimental | Alloderm without radiation Receives: Procedure: Implantation of Dermal Matrix substitute |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects of radiation on acellular dermal matrix
Measured: four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2009 (estimated)
- Study startOct 2008
- Primary completionMay 2011
- Study completionFeb 2015
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jay Agarwal, University of Utah
- Investigators
- Jayant Agarwal, MD, Principal investigator, University of Utah Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00872859
- Sponsor's protocol ID
- 26658
- Status last verified
- May 2017
- First submitted
- 30 Mar 2009
- Last updated
- 18 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The BREASTrial: Breast Reconstruction Evaluation Using Acellular Dermal Matrix as a Sling Trial
- ClinicalTrials.gov ID
- NCT00872859
- Acronym / sponsor ID
- 26658
- Conditions
- Breast Cancer, Reconstructive Surgery
- Keywords
- Breast Cancer, Cancer of Breast, Reconstructive Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- May 2011 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 31 Mar 2009 (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.
Primary Hypothesis:
- Alloderm and Dermamatrix have comparable complication rates when used for staged breast reconstruction
Secondary hypotheses:
- The complication rates following staged breast reconstruction using Alloderm or Dermamatrix are higher if the patient requires radiation compared to those who do not require radiation.
- Dermal matrix incorporation is not altered in patients requiring radiation compared to those who do not require radiation.
- Dermal matrix incorporation is no different when comparing Alloderm and Dermamatrix
Specific aims:
- Evaluate the complication rates in women undergoing staged breast reconstruction with acellular dermal matrix with or without radiation
- Compare the complication rates between the two types of acellular dermal matrix
- Evaluate the histologic characteristics of the dermal matrix exposed to radiation compared to that not exposed to radiation.
- Compare the rates of incorporation of the dermal substance into surrounding tissues of those patients undergoing radiation to those not undergoing radiation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Implantation of Dermal Matrix substituteDermamatrix with radiation |
| 2 | Experimental | Procedure: Implantation of Dermal Matrix substituteDermamatrix without radiation |
| 3 | Experimental | Procedure: Implantation of Dermal Matrix substituteAlloderm with radiation |
| 4 | Experimental | Procedure: Implantation of Dermal Matrix substituteAlloderm without radiation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Plan for immediate temporary breast reconstruction with tissue expander placement and acellular dermal matrix in patients undergoing mastectomy
- Female gender
- Age between 18 and 80
- Consent to participate in the study
Key exclusion criteria (8 listed)
- Patients not undergoing breast reconstruction following mastectomy
- Patients undergoing delayed breast reconstruction following mastectomy
- Patients undergoing immediate definitive breast reconstruction after mastectomy
- Patients requiring definitive reconstruction within 3 months of immediate temporary breast reconstruction
- Medical debility precluding surgical treatment
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 |
|---|---|---|
| Implantation of Dermal Matrix substituteAlso: Dermamatrix, Alloderm, Dermal MatrixDermal Matrix implanted in post mastectomy pts at time of mastectomy. | Procedure or surgery | 1, 2, 3, 4 |
Primary outcome
Effects of radiation on acellular dermal matrix
Time frame: four years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2017.
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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.
Jayant Agarwal, MD principal investigator
University of Utah Hospital
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 Implantation of Dermal Matrix substitute in people with Breast Cancer and Reconstructive Surgery, run by University of Utah 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 4 inclusion and 8 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 18 May 2017. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Effects of radiation on acellular dermal matrix (time frame: four 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 18 May 2017.