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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | 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. |
|
| Group 2 | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Breast MRI | Device |
| ||
| Breast-Q© questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Implant Failure | The multi-beam IMRT 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). | 24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Moderate to Severe Capsular Contracture | Will be examined using number of participants 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. Participants were assigned a Baker Classification score (a standardized 4-point scale, which integrates the texture and appearance of the breast) at baseline and each follow-up interval by the radiation oncologist or plastic surgeon (the higher of the 2 was used if the score was discordant). Significant capsular contracture is measured as Baker grade III or IV. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daphna Gelblum, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge | Basking Ridge | New Jersey | 07920 | United States | ||
| Memorial Sloan Kettering Monmouth |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38570168 | Derived | Khan AJ, Marine CB, Flynn J, Tyagi N, Zhang Z, Thor M, Gelblum D, Mehrara B, McCormick B, Powell SN, Ho AY. A Phase II Study Evaluating the Effect of Intensity Modulated Postmastectomy Radiation Therapy on Implant Failure Rates in Breast Cancer Patients With Immediate, 2-Stage Implant Reconstruction With an MRI Imaging Correlative Substudy. Int J Radiat Oncol Biol Phys. 2024 Oct 1;120(2):482-495. doi: 10.1016/j.ijrobp.2024.03.031. Epub 2024 Apr 2. |
| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | IMRT to Temporary Expander | 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. Breast MRI Breast-Q© questionnaire Multi-Beam IMRT: 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 11, 2019 |
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| Behavioral |
|
| Multi-Beam IMRT | Radiation | 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. |
|
| 24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2 |
| 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. With a focus on the post-operative period, the module will evaluate changes over time in four of the six subthemes identified by Breast-Q: (1) Psychosocial well-being; (2) Physical well-being; (3) Satisfaction with breasts; and (4) Satisfaction with outcome. Each subtheme will be evaluated using one or more scales. Each scale is independently scored into a value that ranges from 0 to 100, with higher score indicating greater satisfaction or better health-related quality of life. | Baseline, Follow-up 1 (Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)), Follow-up 2 (Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)), and Follow-up 3 (Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo)) |
| Middletown |
| New Jersey |
| 07748 |
| United States |
| Memorial Sloan Kettering Cancer Center @ Suffolk | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan Kettering at Mercy Medical Center | Rockville Centre | New York | United States |
| Memorial Sloan Kettering Nassau (Follow-Up only) | Uniondale | New York | 11553 | United States |
| FG001 | IMRT to Permanent Implant | 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 Breast MRI Breast-Q© questionnaire Multi-Beam IMRT: 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
Includes participants who were able to complete study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | IMRT to Temporary Expander | 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. Breast MRI Breast-Q© questionnaire Multi-Beam IMRT: 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. |
| BG001 | IMRT to Permanent Implant | 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 Breast MRI Breast-Q© questionnaire Multi-Beam IMRT: 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Implant Failure | The multi-beam IMRT 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). | Posted | Number | Number of Participants with Implant Fail | 24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2 |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of Moderate to Severe Capsular Contracture | Will be examined using number of participants 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. Participants were assigned a Baker Classification score (a standardized 4-point scale, which integrates the texture and appearance of the breast) at baseline and each follow-up interval by the radiation oncologist or plastic surgeon (the higher of the 2 was used if the score was discordant). Significant capsular contracture is measured as Baker grade III or IV. | Posted | Count of Participants | Participants | 24 months post-IMRT for Group 1, and 30 months post-IMRT for Group 2 |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Count of Participants | Participants | 2 years |
| |||||||||||||||||||||||||||||||||||||||
| Secondary | 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. With a focus on the post-operative period, the module will evaluate changes over time in four of the six subthemes identified by Breast-Q: (1) Psychosocial well-being; (2) Physical well-being; (3) Satisfaction with breasts; and (4) Satisfaction with outcome. Each subtheme will be evaluated using one or more scales. Each scale is independently scored into a value that ranges from 0 to 100, with higher score indicating greater satisfaction or better health-related quality of life. | Posted | Mean | Full Range | scores on a scale | Baseline, Follow-up 1 (Arm 1:12 months (± 2 mo); Arm 2:12-18 months (± 6 mo)), Follow-up 2 (Arm 1:12-18 months (± 6 mo); Arm 2:18 months (± 2 mo)), and Follow-up 3 (Arm 1:24 months (± 2 mo); Arm 2:30 months (± 2 mo)) |
|
2 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IMRT to Temporary Expander | 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. Breast MRI Breast-Q© questionnaire Multi-Beam IMRT: 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. | 0 | 42 | 3 | 42 | 32 | 42 |
| EG001 | IMRT to Permanent Implant | 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 Breast MRI Breast-Q© questionnaire Multi-Beam IMRT: 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. | 8 | 58 | 15 | 58 | 58 | 58 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast infection | Infections and infestations | Systematic Assessment |
| ||
| Breast pain | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Chest pain - cardiac | Cardiac disorders | Systematic Assessment |
| ||
| Chest wall pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dyspnea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Gastrointestinal disorders - Other, specify | Gastrointestinal disorders | Systematic Assessment |
| ||
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Infections and infestations - Other, specify | Infections and infestations | Systematic Assessment |
| ||
| Nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Non-cardiac chest pain | General disorders | Systematic Assessment |
| ||
| Pain in extremity | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Skin infection | Infections and infestations | Systematic Assessment |
| ||
| Wound dehiscence | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Wound infection | Infections and infestations | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine aminotransferase increased | Investigations | Systematic Assessment |
| ||
| Anemia | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| Blood bilirubin increased | Investigations | Systematic Assessment |
| ||
| Hyperglycemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypoalbuminemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypocalcemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypokalemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypomagnesemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hyponatremia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Hypophosphatemia | Metabolism and nutrition disorders | Systematic Assessment |
| ||
| Lymphocyte count decreased | Investigations | Systematic Assessment |
| ||
| Neutrophil count decreased | Investigations | Systematic Assessment |
| ||
| Platelet count decreased | Blood and lymphatic system disorders | Systematic Assessment |
| ||
| White blood cell decreased | Investigations | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Daphna Gelblum, MD | Memorial Sloan Kettering Cancer Center | 914-367-7273 | gelblumd@MSKCC.ORG |
| Aug 26, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | IMRT to Permanent Implant | 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 Breast MRI Breast-Q© questionnaire Multi-Beam IMRT: 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. |
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| OG001 | Arm 2: IMRT to Permanent Implant | 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 Breast MRI Breast-Q© questionnaire Multi-Beam IMRT: 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. |
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