Breast CancerNCT01256528
Delayed-Delayed Breast Reconstruction
A study testing Delayed Breast Reconstruction in people with Breast Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this clinical research study is to learn if delayed-delayed breast reconstruction in women who require post-mastectomy radiation therapy will improve cosmetic outcomes and result in fewer complications compared to the standard approach (reconstruction that is not started until radiation treatment is… 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?
- Delayed Breast Reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Sep 2015
- Phase
- Interventional
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with invasive breast carcinoma that are scheduled for a mastectomy with planned postmastectomy XRT. This includes, but is not limited to, clinical stage II, III, and IV.
- Patient must desire breast reconstruction.
- Patients must sign the informed consent form and must be deemed by operative surgeon not to have medical contraindications for delayed-delayed approach.
- Patients must be 18 years of age or older.
Who cannot join
- Patients in whom it is not known preoperatively to need postmastectomy radiation therapy.
- Patients with inflammatory breast cancer.
- Patients in whom the breast skin can not be spared because of involvement with breast cancer.
- Any patient deemed by the radiation oncologist during preoperative consultation to be an inappropriate patient for this protocol.
- Patients that can not commit to receiving postmastectomy radiation treatment in addition to breast reconstructive procedures at MD Anderson Cancer Center or satellite affiliates.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: A Multidisciplinary Protocol for Planned Skin-Preserving Delayed Breast Reconstruction for Patients With Locally Advanced Breast Cancer Requiring Postmastectomy Radiation Therapy
The goal of this clinical research study is to learn if delayed-delayed breast reconstruction in women who require post-mastectomy radiation therapy will improve cosmetic outcomes and result in fewer complications compared to the standard approach (reconstruction that is not started until radiation treatment is completed).
Read the detailed description
Study Visits and Surgeries:
You will be hospitalized 2-4 times for 1-5 days depending on your condition. If you agree to take part in this study, you will be scheduled for a skin-sparing mastectomy. The following tests and procedures will be performed:
Pre-Operative Visit:
- Your complete medical history will be updated.
- The doctor will determine what type of reconstructive surgery can be done.
- You will have photos taken of your breasts. Your face, hair, or jewelry will not be photographed. These photos will be kept in a password-protected computer accessible only by the principle investigator and people directly involved in this study.
- You will complete a quality of life questionnaire. The questionnaire asks about how satisfied you are with your appearance. The questionnaire will be sent by email, US postal service mail, or in person when you come for your follow up visits. The questionnaire should take about 20 minutes to complete. If sent by US postal service, you will be given a postage-paid envelope to return the questionnaire.
At your Mastectomy Surgery:
- Your complete medical history will be updated.
- You will have photos taken of your breasts.
- During the surgery, a tissue expander will be placed in your breast. Sterile salt water will be added to inflate the expander and a small skin sample (about the size of a pencil eraser) from the breast will be taken to study stretching and scarring of the skin. The tissue will be securely maintained at MD Anderson.
- You will be monitored for any problems.
Post-Operative Visit - 7 to 10 Days after Mastectomy Surgery:
- The study staff will look at the results of your surgery.
- Your complete medical history will be updated.
- You will complete the quality of life questionnaire.
- You will be asked about any problems you may be having.
Deflation Visit - Week 5:
- Your complete medical history will be updated.
- You will have photos taken of your breasts.
- The sterile salt water in the expander will be let out, causing the breast to go flat. This is done by inserting a needle into a special port and withdrawing the fluid with a syringe.
Radiation Visit - Week 8:
- You must have radiation either at M. D. Anderson or an M. D. Anderson-affiliated site.
- Extra fluid may be added to the tissue expander before radiation.
- The study staff will look at the results of your surgery.
- You will be asked about any problems you may be having.
- You will receive radiation, typically 5 days a week for 6 weeks.
Post-Radiation Visits - About Week 13 and every 2 to 4 Weeks after:
- Your complete medical history will be updated.
- The study staff will look at the results of your surgery.
- You will be asked about any problems you may be having.
- You will complete the quality of life questionnaire.
- Your expander will be re-inflated.
Delayed-delayed Reconstruction Surgery - At about Week 23:
- Your complete medical history will be updated.
- You will have photos taken of your breasts.
- During surgery, you will be monitored for any problems. A tissue sample will be collected to study stretching and scarring of the skin from the mastectomy incision and the tissue that is used to form the new breast. The tissue will be securely maintained at MD Anderson.
- During surgery, you will have tissue moved from your lower abdomen, back, or buttock to be used for reconstruction. A silicone or saline breast implant may or may not be used to help construct the breast. The amount of tissue used for building the breast will depend on your body size and donation site. Your reconstructive surgeon will discuss this with you before surgery.
- During surgery, the expander will be removed and reconstruction of your breast will occur.
Follow-Up Surgery - At about Week 47:
- Your complete medical history will be updated.
- You will have photos taken of your breasts.
- You will complete the quality of life questionnaire.
- During surgery, you will be monitored for any problems and a tissue sample will be collected.
- During this surgery, procedures will be done to improve the appearance of the breast.
Long-Term Follow-Up Visits - At 6, 12, 24, and 36 Months:
- Your complete medical history will be updated.
- You will have photos taken of your breasts.
- You will be asked about any problems you may be having.
- At Months 12 and 24, you will complete the quality of life questionnaire.
This is an investigational study. The implants in this study have been FDA approved for skin expansion as a method of breast reconstruction. The use of the implants is investigational in this study.
Up to 200 women will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Breast Cancer
- Being tested
- Delayed Breast Reconstruction
- Keywords
- Invasive breast carcinoma, Breast reconstruction, Mastectomy, Breast cancer, Delayed-delayed breast reconstruction, Post-mastectomy radiation therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delayed Breast ReconstructionProcedure or surgery
Approximately 3 months after postmastectomy radiation therapy, the preserved, irradiated, and re-inflated breast skin will be used to perform the delayed breast reconstruction. During the stage 2 reconstruction, the implant or expander will be removed and the definitive reconstruction will be performed with the preserved breast skin utilizing a preference for autologous tissue or autologous tissue with an implant due to the potential for complications with implant-based reconstructions after radiation therapy (XRT).
| Study group | Role | What they receive |
|---|---|---|
| Delayed Breast Reconstruction | Experimental | Approximately 3 months after postmastectomy radiation therapy, the preserved, irradiated, and re-inflated breast skin will be used to perform the delayed breast reconstruction. During the stage 2 reconstruction, the implant or expander will be removed and the definitive reconstruction will be performed with the preserved breast skin utilizing a preference for autologous tissue or autologous tissue with an implant due to the potential for complications with implant-based reconstructions after radiation therapy (XRT). Receives: Procedure: Delayed Breast Reconstruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Complication Rate
Overall complication defined as any of the following complications post breast reconstruction surgery: seroma, hematoma, wound dehiscence, partial flap loss, total flap loss, infection, flap microvascular thrombosis (arterial or venous), venous congestion of flap, flap fat necrosis, mastectomy skin flap necrosis, exposure breast implant, capsular contracture, and delayed wound healing.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionSep 2015
- Study completionSep 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.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven J. Kronowitz, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01256528
- Sponsor's protocol ID
- 2010-0053
- Other IDs
- NCI-2011-00270
- Status last verified
- Jul 2016
- First submitted
- 7 Dec 2010
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multidisciplinary Protocol for Planned Skin-Preserving Delayed Breast Reconstruction for Patients With Locally Advanced Breast Cancer Requiring Postmastectomy Radiation Therapy
- ClinicalTrials.gov ID
- NCT01256528
- Acronym / sponsor ID
- 2010-0053
- Conditions
- Breast Cancer
- Keywords
- Invasive breast carcinoma, Breast reconstruction, Mastectomy, Breast cancer, Delayed-delayed breast reconstruction, Post-mastectomy radiation therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 8 Dec 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.
The goal of this clinical research study is to learn if delayed-delayed breast reconstruction in women who require post-mastectomy radiation therapy will improve cosmetic outcomes and result in fewer complications compared to the standard approach (reconstruction that is not started until radiation treatment is completed).
Detailed description
Study Visits and Surgeries:
You will be hospitalized 2-4 times for 1-5 days depending on your condition. If you agree to take part in this study, you will be scheduled for a skin-sparing mastectomy. The following tests and procedures will be performed:
Pre-Operative Visit:
- Your complete medical history will be updated.
- The doctor will determine what type of reconstructive surgery can be done.
- You will have photos taken of your breasts. Your face, hair, or jewelry will not be photographed. These photos will be kept in a password-protected computer accessible only by the principle investigator and people directly involved in this study.
- You will complete a quality of life questionnaire. The questionnaire asks about how satisfied you are with your appearance. The questionnaire will be sent by email, US postal service mail, or in person when you come for your follow up visits. The questionnaire should take about 20 minutes to complete. If sent by US postal service, you will be given a postage-paid envelope to return the questionnaire.
At your Mastectomy Surgery:
- Your complete medical history will be updated.
- You will have photos taken of your breasts.
- During the surgery, a tissue expander will be placed in your breast. Sterile salt water will be added to inflate the expander and a small skin sample (about the size of a pencil eraser) from the breast will be taken to study stretching and scarring of the skin. The tissue will be securely maintained at MD Anderson.
- You will be monitored for any problems.
Post-Operative Visit - 7 to 10 Days after Mastectomy Surgery:
- The study staff will look at the results of your surgery.
- Your complete medical history will be updated.
- You will complete the quality of life questionnaire.
- You will be asked about any problems you may be having.
Deflation Visit - Week 5:
- Your complete medical history will be updated.
- You will have photos taken of your breasts.
- The sterile salt water in the expander will be let out, causing the breast to go flat. This is done by inserting a needle into a special port and withdrawing the fluid with a syringe.
Radiation Visit - Week 8:
- You must have radiation either at M. D. Anderson or an M. D. Anderson-affiliated site.
- Extra fluid may be added to the tissue expander before radiation.
- The study staff will look at the results of your surgery.
- You will be asked about any problems you may be having.
- You will receive radiation, typically 5 days a week for 6 weeks.
Post-Radiation Visits - About Week 13 and every 2 to 4 Weeks after:
- Your complete medical history will be updated.
- The study staff will look at the results of your surgery.
- You will be asked about any problems you may be having.
- You will complete the quality of life questionnaire.
- Your expander will be re-inflated.
Delayed-delayed Reconstruction Surgery - At about Week 23:
- Your complete medical history will be updated.
- You will have photos taken of your breasts.
- During surgery, you will be monitored for any problems. A tissue sample will be collected to study stretching and scarring of the skin from the mastectomy incision and the tissue that is used to form the new breast. The tissue will be securely maintained at MD Anderson.
- During surgery, you will have tissue moved from your lower abdomen, back, or buttock to be used for reconstruction. A silicone or saline breast implant may or may not be used to help construct the breast. The amount of tissue used for building the breast will depend on your body size and donation site. Your reconstructive surgeon will discuss this with you before surgery.
- During surgery, the expander will be removed and reconstruction of your breast will occur.
Follow-Up Surgery - At about Week 47:
- Your complete medical history will be updated.
- You will have photos taken of your breasts.
- You will complete the quality of life questionnaire.
- During surgery, you will be monitored for any problems and a tissue sample will be collected.
- During this surgery, procedures will be done to improve the appearance of the breast.
Long-Term Follow-Up Visits - At 6, 12, 24, and 36 Months:
- Your complete medical history will be updated.
- You will have photos taken of your breasts.
- You will be asked about any problems you may be having.
- At Months 12 and 24, you will complete the quality of life questionnaire.
This is an investigational study. The implants in this study have been FDA approved for skin expansion as a method of breast reconstruction. The use of the implants is investigational in this study.
Up to 200 women will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Delayed Breast Reconstruction | Experimental | Procedure: Delayed Breast ReconstructionApproximately 3 months after postmastectomy radiation therapy, the preserved, irradiated, and re-inflated breast skin will be used to perform the delayed breast reconstruction. During the stage 2 reconstruction, the implant or expander will be removed and the definitive reconstruction will be performed with the preserved breast skin utilizing a preference for autologous tissue or autologous tissue with an implant due to the potential for complications with implant-based reconstructions after radiation therapy (XRT). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with invasive breast carcinoma that are scheduled for a mastectomy with planned postmastectomy XRT. This includes, but is not limited to, clinical stage II, III, and IV.
- Patient must desire breast reconstruction.
- Patients must sign the informed consent form and must be deemed by operative surgeon not to have medical contraindications for delayed-delayed approach.
- Patients must be 18 years of age or older.
Key exclusion criteria (5 listed)
- Patients in whom it is not known preoperatively to need postmastectomy radiation therapy.
- Patients with inflammatory breast cancer.
- Patients in whom the breast skin can not be spared because of involvement with breast cancer.
- Any patient deemed by the radiation oncologist during preoperative consultation to be an inappropriate patient for this protocol.
- Patients that can not commit to receiving postmastectomy radiation treatment in addition to breast reconstructive procedures at MD Anderson Cancer Center or satellite affiliates.
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 |
|---|---|---|
| Delayed Breast ReconstructionApproximately 3 months after postmastectomy radiation therapy, the preserved, irradiated, and re-inflated breast skin will be used to perform the delayed breast reconstruction. During the stage 2 reconstruction, the implant or expander will be removed and the definitive reconstruction will be performed with the preserved breast skin utilizing a preference for autologous tissue or autologous tissue with an implant due to the potential for complications with implant-based reconstructions after radiation therapy (XRT). | Procedure or surgery | Delayed Breast Reconstruction |
Primary outcome
Overall Complication Rate
Time frame: 6 months
Overall complication defined as any of the following complications post breast reconstruction surgery: seroma, hematoma, wound dehiscence, partial flap loss, total flap loss, infection, flap microvascular thrombosis (arterial or venous), venous congestion of flap, flap fat necrosis, mastectomy skin flap necrosis, exposure breast implant, capsular contracture, and delayed wound healing.
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 15 Jul 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Steven J. Kronowitz, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Delayed Breast Reconstruction in people with Breast Cancer, run by M.D. Anderson Cancer Center 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 5 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 15 Jul 2016. 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.
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?
Overall Complication Rate (time frame: 6 months). 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 15 Jul 2016.