Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions

Study Overview
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Brief Summary
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The purpose of this study is to determine if a radiation treatment called Multi-beam Intensity Modulated Radiation Therapy(IMRT) can reduce side effects related to your implant if they are a candidate for radiation therapy. Currently, the standard method of giving radiation is with 3D radiation, which only uses 2-5 beams of radiation. Multi-beam IMRT works by using 8-12 small radiation beams to give a more tailored or customized radiation dose to the implant, breast, chest wall and lymph nodes. At the same time, multi-beam IMRT may lower the radiation dose to the heart, lung and nearby tissues. The goal of the study is to reduce complications after irradiation to the implants. The study doctors have recently completed a trial using this technique and are now specifically looking at its impact on women with implant reconstructions who are undergoing post-mastectomy radiation therapy. By delivering a more customized dose of radiation to the implant, the intent is to reduce side effects of radiation on the implant.

Detailed Description
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Patients will undergo mastectomy and axillary dissection with immediate tissue expander placement. As is the current practice at MSKCC, patients receiving adjuvant chemotherapy will undergo expansion during chemotherapy, with exchange for a permanent implant to be performed approximately one month after chemotherapy and radiation to begin approximately one month after exchange. Patients who receive neoadjuvant chemotherapy will undergo rapid expansion of the expander and begin radiation at least 4 weeks following surgery, although it may be performed sooner if the patient has recovered from surgery and the treating physician deems it safe to proceed with treatment. In these patients, exchange for the permanent implant will occur at the discretion of the treating plastic surgeon (approximately 5-8 months after the end of radiation).

Official Title
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Phase II Study Assessing the Potential for Reduced Rates of Implant Failure Using Multi-Beam Intensity-Modulated Radiation Therapy for Locally Advanced Breast Cancer Patients With Implant Reconstructions

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Breast MRI
* Behavioral: Breast-Q© questionnaire
* Radiation: Multi-Beam IMRT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Females who are age ≥ 18 years of age with a life expectancy estimated to be at least 2 years Histologically-confirmed invasive breast cancer by MSKCC Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Status post mastectomy with surgical assessment of axillary nodes Immediate reconstruction with tissue expander (Group 2) or permanent implant (Group 1) prior to RT performed at MSKCC If PMRT is recommended, the treatment fields will include the axillary, supraclavicular, and internal mammary nodes. Exclusion Criteria: Absence of a breast reconstruction prior to RT (placement of tissue expander is sufficient for group 2) Pregnant or breastfeeding. Psychiatric or addictive disorders that would preclude obtaining informed consent or filling out Breast-Q© questionnaires. Prior radiation therapy to the ipsilateral breast/nodes or thorax. The criterias outlined above apply to the patients enrolled to meet the primary objective of the study. Additional criteria for patients in the cardiac substudy portion of the protocol are outlined in the protocol

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

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
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT. Total length of the follow-up time will be 24 ± 2 months post-IMRT. A subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session. A CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time. Myocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer. A follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT. | Device: Breast MRI<br> <br> Behavioral: Breast-Q© questionnaire<br> <br> Radiation: Multi-Beam IMRT<br>* The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.<br>|
| Experimental: Group 2<br>Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon). Total length of the follow-up time will be 30 ± 2 months post-IMRT | Device: Breast MRI<br> <br> Behavioral: Breast-Q© questionnaire<br> <br> Radiation: Multi-Beam IMRT<br>* The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy of multi-beam IMRT | The treatment would be considered efficacious if the incidence of implant failure is reduced by at least a relative 30% by the end of the study period (24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2). | 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of moderate to severe capsular contracture | will be examined using proportions of patients who developed Baker's grade <2 and ≥2 capsular contracture, respectively, at 12 or 18 months and 24 or 30 months after IMRT was administered. | 30 months | 
| rates of minor revisional surgeries | Incidence of minor revisional surgeries by plastic surgeon will be evaluated by proportions too. Again, the rates (proportions) will be compared across the two groups. | 2 years | 
| evaluate cosmesis | To evaluate cosmesis, the Breast-Q© will be utilized in these assessments and will be presented descriptively, giving summary statistics for changes in the Breast-Q© scores over time. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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multi-beam Intensity-Modulated Radiation Therapy (IMRT), 14-028