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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Breast MRI; Behavioral: Breast-Q© questionnaire; Radiation: Multi-Beam IMRT

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Memorial Sloan Kettering at Basking Ridge
    • Middletown, New Jersey, United States, 07748
      • Memorial Sloan Kettering Monmouth
  • New York
    • Commack, New York, United States, 11725
      • Memorial Sloan Kettering Cancer Center @ Suffolk
    • Harrison, New York, United States, 10604
      • Memorial Sloan Kettering Westchester
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center
    • Rockville Centre, New York, United States
      • Memorial Sloan Kettering at Mercy Medical Center
    • Uniondale, New York, United States, 11553
      • Memorial Sloan Kettering Nassau (Follow-Up only)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; 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; Behavioral: Breast-Q© questionnaire; Radiation: 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.
Experimental: Group 2; 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; Behavioral: Breast-Q© questionnaire; Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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))

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Daphna Gelblum, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2014
• Primary Completion (Actual): September 13, 2024
• Study Completion (Actual): September 13, 2024

Study Registration Dates

• First Submitted: March 11, 2014
• First Submitted That Met QC Criteria: March 11, 2014
• First Posted (Estimated): March 13, 2014

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: December 30, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: multi-beam Intensity-Modulated Radiation Therapy (IMRT); 14-028
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: 14-028