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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
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

Full criteria on ClinicalTrials.gov

Sites (7)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Memorial Sloan Kettering at Basking Ridge
Coordinator of this site? Confirm its status
Basking RidgeUnited StatesUnknown status
Memorial Sloan Kettering Cancer Center @ Suffolk
Coordinator of this site? Confirm its status
CommackUnited StatesUnknown status
Memorial Sloan Kettering Westchester
Coordinator of this site? Confirm its status
HarrisonUnited StatesUnknown status
Memorial Sloan Kettering Monmouth
Coordinator of this site? Confirm its status
MiddletownUnited StatesUnknown status
Memorial Sloan-Kettering Cancer Center
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status
Memorial Sloan Kettering at Mercy Medical Center
Coordinator of this site? Confirm its status
Rockville CentreUnited StatesUnknown status
Memorial Sloan Kettering Nassau (Follow-Up only)
Coordinator of this site? Confirm its status
UniondaleUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.