Cosmetic Result/Toxicity in Post-Mastectomy Immediate Reconstruction Expander+RT

Study Overview
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Brief Summary
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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
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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).

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Radiation: post-mastectomy radiation therapy (PMRT)
* Device: tissue expander (TE)
* Device: acellular dermal matrix (ADM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TE-ADM with PMRT<br>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. | Radiation: post-mastectomy radiation therapy (PMRT)<br> <br> Device: tissue expander (TE)<br> <br> Device: acellular dermal matrix (ADM)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Dose-Volume | Lung dose-volumes were assessed as a percentage of the ipsilateral lung irradiated via dose-volume histograms. | 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. | 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. | 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. | 2 Years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tissue expander, acellular dermal matrix