Breast CancerNCT01664091
Cosmetic Result/Toxicity in Post-Mastectomy Immediate Reconstruction Expander+RT
A study testing post-mastectomy radiation therapy (PMRT), tissue expander (TE) and acellular dermal matrix (ADM) in people with Breast Cancer, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
This research study is being done to carefully evaluate the effect of giving radiation therapy after temporary breast reconstruction. The investigators want to see if this type of reconstruction combined with radiation will look better (once the final reconstruction has been completed) and will reduce the risk that… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- post-mastectomy radiation therapy (PMRT), tissue expander (TE) and acellular dermal matrix (ADM)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Sep 2015
- Phase
- Interventional
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have newly diagnosed, clinical Stage I-III breast cancer with T1-T3 invasive tumors recently treated with mastectomy
- Patients must have had immediate reconstruction with a TE and ADM
- Participants must be candidates for postmastectomy radiation therapy (RT). Postmastectomy RT routinely is indicated for patients with pathologically-staged T3N1 (or higher stage) tumors, T1-T2 tumors with 4 or more positive nodes, some T1-T2 tumors with 1-3 positive nodes, and, infrequently, for some N0 tumors
- Axillary nodes may be positive or negative
- Microscopically positive margins are permitted
- Systemic therapy as recommended by a medical oncologist, pre-or post-mastectomy, is permitted
- Patients must agree to return for scheduled follow-up visits with their radiation oncologist 6, 12, 18 and 24 months after RT (+/- 1 month)
- 18 years of age or older
Who cannot join
- Participants with T4 tumors
- Participants with recurrent breast cancer or a history of prior breast RT
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study
- Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
- HIV-positive individuals on combination antiretroviral therapy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
About this study
Official title: An Evaluation of Cosmetic Results and Toxicity in the Use of Post-Mastectomy Immediate Reconstruction With a Tissue Expander and Acellular Dermal Matrix Followed by Radiation Therapy
This research study is being done to carefully evaluate the effect of giving radiation therapy after temporary breast reconstruction. The investigators want to see if this type of reconstruction combined with radiation will look better (once the final reconstruction has been completed) and will reduce the risk that the participant will develop complications that sometimes occur with other kinds of reconstruction procedures. The investigators also want to know if it is easier to give the radiation with this type of reconstruction than with other kinds of reconstruction procedures. The reconstruction procedure involves the temporary use of a tissue expander and an acellular dermal matrix (ADM).
Read the detailed description
- ADMs have been used in combination with a tissue expander and radiotherapy but have not been studied formally in terms of their ability to avoid complications sometimes seen with other methods of reconstruction and improve the delivery of the radiation. The only difference between being on the study and not being on the study is that the research team will analyze the records of those who participate to see how easy it was to give the radiation, how good the cosmetic outcome of the reconstruction is and what, if any, complications occured.
- A minimum of 6 weeks between the surgery and the start of radiation therapy is required to allow for adequate healing. Often this interval will be longer, as many patients will receive chemotherapy in the interim. There is no maximum time from surgery to radiation.
- Around the time of radiation planning, the radiation oncologist and plastic surgeon will agree upon how much deflation of the tissue expander will be required to permit simulation of the radiation therapy.
- Radiation therapy to the chest wall (with or without adjacent lymph nodes) will be given once daily Monday through Friday over 5-7 weeks.
- After the completion of the radiation therapy, the tissue expander will be re-expanded and eventually replaced by the permanent implant or flap reconstruction at the discretion of the plastic surgeon.
- Participants will be expected to return to the Radiation Oncology Clinic for follow-up visits 6, 12, 18 and 24 months after the end of the radiation therapy. Evaluation of cosmetic results and complications will be done at these visits using a recognized scoring system and photographs taken at each time point and scored for specific items (necrosis, telangiectasia, etc).
- Conditions
- Breast Cancer
- Being tested
- post-mastectomy radiation therapy (PMRT), tissue expander (TE), acellular dermal matrix (ADM)
- Keywords
- tissue expander, acellular dermal matrix
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
post-mastectomy radiation therapy (PMRT)Radiation
tissue expander (TE)Device
acellular dermal matrix (ADM)Device
| Study group | Role | What they receive |
|---|---|---|
| TE-ADM with PMRT | Experimental | Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 5 months after completion of PMRT. Receives: Radiation: post-mastectomy radiation therapy (PMRT); Device: tissue expander (TE); Device: acellular dermal matrix (ADM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate
Success rate was defined as the percentage of participants experiencing all of the following: 1) completion of PMRT and placement of the permanent implant and/or flap reconstruction; 2) no major complications (infection requiring hospitalization, major revisions, early/severe capsular contracture, or pain requiring implant removal); and 3) a physician-reported 'excellent' or 'good' cosmetic result (not 'fair' or 'poor') at 2 years following PMRT (requiring a stable reconstruction with good symmetry and contour relative to the contralateral breast).
Measured: 2 years
Secondary outcomes (4)
Lung Dose-Volume
Lung dose-volumes were assessed as a percentage of the ipsilateral lung irradiated via dose-volume histograms.
Measured: Lung dose-volume was measured at the end of radiation therapy which was up to 11 weeks from enrollment in this study cohort.
Cosmetic Score
Cosmesis was measured by means of strict photographic analysis using five views (frontal, right and left lateral, and right and left quarter views) and independent assessment of the results by a plastic surgeon or radiation oncologist who has not treated the patient. Cosmetic score was defined in 4 categories: Excellent = treated breast looks essentially the same as the opposite breast; Good = minimal but identifiable result of treatment; Fair = significant effects of radiation therapy noted; Poor = severe normal tissue sequelae.
Measured: 2 years
Baker Classification Peak Score
An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention.
Measured: Assessed up to 2 years post PMRT
Baker Classification 2-Year Score
An independent assessment of contracture was conducted by a plastic surgeon or radiation oncologist who had not treated the participant. Photographic analysis incorporated five views (frontal, right and left lateral, and right and left quarter views). Baker classification was used to score the extent of contracture: Class IA-absolutely natural, cannot tell breast was reconstructed; Class IB-soft, but the implant is detectable by physical examination or inspection because of mastectomy; Class II-mildly firm reconstructed breast with an implant that may be visible and detectable by physical examination; Class III-moderately firm reconstructed breast with readily detectable implant, but the result may still be acceptable; or Class IV-severe capsular contracture with an unacceptable aesthetic outcome and/or significant patient symptoms requiring surgical intervention.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2012 (estimated)
- Study startSep 2009
- Primary completionSep 2015
- Study completionSep 2015
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.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Julia S. Wong, MD, Dana-Farber Cancer Institute
- Investigators
- Julia Wong, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01664091
- Sponsor's protocol ID
- 09-254
- Status last verified
- Aug 2019
- First submitted
- 22 Jun 2011
- Last updated
- 26 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Evaluation of Cosmetic Results and Toxicity in the Use of Post-Mastectomy Immediate Reconstruction With a Tissue Expander and Acellular Dermal Matrix Followed by Radiation Therapy
- ClinicalTrials.gov ID
- NCT01664091
- Acronym / sponsor ID
- 09-254
- Conditions
- Breast Cancer
- Keywords
- tissue expander, acellular dermal matrix
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- Sep 2009 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 14 Aug 2012 (estimated)
- Results
- Posted 26 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being done to carefully evaluate the effect of giving radiation therapy after temporary breast reconstruction. The investigators want to see if this type of reconstruction combined with radiation will look better (once the final reconstruction has been completed) and will reduce the risk that the participant will develop complications that sometimes occur with other kinds of reconstruction procedures. The investigators also want to know if it is easier to give the radiation with this type of reconstruction than with other kinds of reconstruction procedures. The reconstruction procedure involves the temporary use of a tissue expander and an acellular dermal matrix (ADM).
Detailed description
- ADMs have been used in combination with a tissue expander and radiotherapy but have not been studied formally in terms of their ability to avoid complications sometimes seen with other methods of reconstruction and improve the delivery of the radiation. The only difference between being on the study and not being on the study is that the research team will analyze the records of those who participate to see how easy it was to give the radiation, how good the cosmetic outcome of the reconstruction is and what, if any, complications occured.
- A minimum of 6 weeks between the surgery and the start of radiation therapy is required to allow for adequate healing. Often this interval will be longer, as many patients will receive chemotherapy in the interim. There is no maximum time from surgery to radiation.
- Around the time of radiation planning, the radiation oncologist and plastic surgeon will agree upon how much deflation of the tissue expander will be required to permit simulation of the radiation therapy.
- Radiation therapy to the chest wall (with or without adjacent lymph nodes) will be given once daily Monday through Friday over 5-7 weeks.
- After the completion of the radiation therapy, the tissue expander will be re-expanded and eventually replaced by the permanent implant or flap reconstruction at the discretion of the plastic surgeon.
- Participants will be expected to return to the Radiation Oncology Clinic for follow-up visits 6, 12, 18 and 24 months after the end of the radiation therapy. Evaluation of cosmetic results and complications will be done at these visits using a recognized scoring system and photographs taken at each time point and scored for specific items (necrosis, telangiectasia, etc).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TE-ADM with PMRT | Experimental | Radiation: post-mastectomy radiation therapy (PMRT), Device: tissue expander (TE), Device: acellular dermal matrix (ADM)Participants received immediate breast reconstruction using a sub-muscular tissue expander (TE) and acellular dermal matrix (ADM) sling placed during the same surgery. This was followed by post-mastectomy radiation therapy (PMRT) no sooner than a minimum of 6 weeks and optimally 6 months, if adjuvant chemotherapy was required. The prescribed chest-wall dose was 50 -50.4 gray (Gy) in 25-28 fractions given once daily over 5-7 weeks with a 0.5-centimeter (cm) bolus to the scar every other day. Permanent reconstruction was performed at least 5 months after completion of PMRT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have newly diagnosed, clinical Stage I-III breast cancer with T1-T3 invasive tumors recently treated with mastectomy
- Patients must have had immediate reconstruction with a TE and ADM
- Participants must be candidates for postmastectomy radiation therapy (RT). Postmastectomy RT routinely is indicated for patients with pathologically-staged T3N1 (or higher stage) tumors, T1-T2 tumors with 4 or more positive nodes, some T1-T2 tumors with 1-3 positive nodes, and, infrequently, for some N0 tumors
- Axillary nodes may be positive or negative
- Microscopically positive margins are permitted
Key exclusion criteria (6 listed)
- Participants with T4 tumors
- Participants with recurrent breast cancer or a history of prior breast RT
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Pregnant women are excluded from this study
- Individuals with a history of a different malignancy are ineligible except for the following circumstances. Individuals with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence of that malignancy. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin
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 |
|---|---|---|
| post-mastectomy radiation therapy (PMRT) | Radiation | TE-ADM with PMRT |
| tissue expander (TE) | Device | TE-ADM with PMRT |
| acellular dermal matrix (ADM) | Device | TE-ADM with PMRT |
Primary outcome
Success Rate
Time frame: 2 years
Success rate was defined as the percentage of participants experiencing all of the following: 1) completion of PMRT and placement of the permanent implant and/or flap reconstruction; 2) no major complications (infection requiring hospitalization, major revisions, early/severe capsular contracture, or pain requiring implant removal); and 3) a physician-reported 'excellent' or 'good' cosmetic result (not 'fair' or 'poor') at 2 years following PMRT (requiring a stable reconstruction with good symmetry and contour relative to the contralateral breast).
4 secondary outcomes
Lung Dose-Volume
Time frame: Lung dose-volume was measured at the end of radiation therapy which was up to 11 weeks from enrollment in this study cohort.
Cosmetic Score
Time frame: 2 years
Baker Classification Peak Score
Time frame: Assessed up to 2 years post PMRT
Baker Classification 2-Year Score
Time frame: 2 Years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Julia Wong, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing post-mastectomy radiation therapy (PMRT), tissue expander (TE) and acellular dermal matrix (ADM) in people with Breast Cancer, run by Dana-Farber Cancer Institute at 2 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 8 inclusion and 6 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 26 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Aug 2019). 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?
Success Rate (time frame: 2 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 26 Aug 2019.