NCT02086578CompletedPhase 2
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
Source: ClinicalTrials.gov · Last updated 20 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 11 Mar 2014
- Start date
- 11 Mar 2014
- Primary completion date
- 13 Sept 2024
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Diseases
- Metastatic breast cancer
- NCT number
- NCT02086578
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 100
- From 11 Mar 2014 to the primary completion date, 13 Sept 2024
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Absence of a breast reconstruction prior to RT (placement of tissue expander is sufficient for group 2)
- Prior radiation therapy to the ipsilateral breast/nodes or thorax.
Other illness
- Psychiatric or addictive disorders that would preclude obtaining informed consent or filling out Breast-Q© questionnaires.
- 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
Other
- Pregnant or breastfeeding.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Memorial Sloan Kettering at Basking Ridge Coordinator of this site? Confirm its status | Basking Ridge | United States | Unknown status |
| Memorial Sloan Kettering Cancer Center @ Suffolk Coordinator of this site? Confirm its status | Commack | United States | Unknown status |
| Memorial Sloan Kettering Westchester Coordinator of this site? Confirm its status | Harrison | United States | Unknown status |
| Memorial Sloan Kettering Monmouth Coordinator of this site? Confirm its status | Middletown | United States | Unknown status |
| Memorial Sloan-Kettering Cancer Center Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Memorial Sloan Kettering at Mercy Medical Center Coordinator of this site? Confirm its status | Rockville Centre | United States | Unknown status |
| Memorial Sloan Kettering Nassau (Follow-Up only) Coordinator of this site? Confirm its status | Uniondale | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.