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New radiation technique aims to save implants in breast cancer patients

NCT ID NCT02086578

Symptom relief Sponsor: Memorial Sloan Kettering Cancer Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a radiation method called multi-beam IMRT in 100 women with breast cancer who had implant reconstructions after mastectomy. The goal was to see if using 8-12 small radiation beams instead of the standard 2-5 could reduce implant failure and side effects. Results focused on lowering complications like capsular contracture and implant loss within 2-2.5 years after treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

100 people

The number who actually took part.

Started

Mar 2014

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Cancer Center @ Suffolk

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau (Follow-Up only)

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    Harrison, New York, 10604, United States

  • Memorial Sloan Kettering at Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering at Mercy Medical Center

    Rockville Centre, New York, United States

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