Phase 2
N=100
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
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02086578 ↗Enrolled (actual)
100
Serious AEs
18.0%
Results posted
Jan 2026
Primary outcome: Primary: Incidence of Implant Failure — 8; 17; 34; 41 Number of Participants with Implant Fail
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Breast MRI (Device); Breast-Q© questionnaire (Behavioral); Multi-Beam IMRT (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Primary completion
- Sep 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Implant Failure |
8; 17; 34; 41 | — |
| SECONDARY Incidence of Moderate to Severe Capsular Contracture |
26; 36; 16; 11; 0; 11 | — |
| SECONDARY Rates of Minor Revisional Surgeries |
0; 2; 42; 56 | — |
| SECONDARY Evaluate Cosmesis |
84; 64; 70; 59; 76; 69 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02086578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.