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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT02086578

Run by

Memorial Sloan Kettering Cancer Center

People needed

100

Starts

2014-03-11

Expected to finish

2024-09-13

Last updated by the study team

2026-01-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Memorial Sloan Kettering at Basking Ridge — Basking Ridge, New Jersey, United States
• Memorial Sloan Kettering Monmouth — Middletown, New Jersey, United States
• Memorial Sloan Kettering Cancer Center @ Suffolk — Commack, New York, United States
• Memorial Sloan Kettering Westchester — Harrison, New York, United States
• Memorial Sloan Kettering Cancer Center — New York, New York, 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, United States

Full record on ClinicalTrials.gov

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