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Radiation Therapy

IMRT for Breast Cancer with Implants

Q: Does the Breast-Q© questionnaire present any risks to participants?

<p>The observed safety of the <a href="https://www.withpower.com/clinical-trials/breast">Breast</a>-Q© questionnaire has been assessed as a 2, since data supports its security but there is no empirical evidence for efficacy.</p>

Phase 2

Waitlist Available

Led By Daphna Gelblum, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study Summary

This trial is testing a new way to give radiation that may help reduce side effects related to your implant.

Who is the study for?

This trial is for women over 18 with invasive breast cancer who've had a mastectomy and implant reconstruction, and are recommended post-mastectomy radiation therapy including to lymph nodes. They should be in good health with a life expectancy of at least 2 years. Not eligible if pregnant, breastfeeding, unable to consent or complete questionnaires due to psychiatric disorders, without prior reconstruction, or previous radiation on the same area.Check my eligibility

What is being tested?

The study tests Multi-Beam Intensity Modulated Radiation Therapy (IMRT) versus standard 3D radiation in reducing side effects on implants after breast cancer surgery. IMRT uses more beams for tailored dosing that may protect the heart and lungs better while treating the breast, chest wall, and lymph nodes.See study design

What are the potential side effects?

Potential side effects include those typical of radiation therapy such as skin irritation around the treated area, fatigue, swelling or pain in the irradiated region. The goal is to see if IMRT reduces these compared to conventional methods.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a woman over 18 and expected to live at least 2 more years.

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My breast cancer diagnosis was confirmed by MSKCC.

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I have had a mastectomy and my underarm lymph nodes were checked.

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I had immediate breast reconstruction with an implant or expander before radiation at MSKCC.

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I am fully active or can carry out light work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

efficacy of multi-beam IMRT

Secondary outcome measures

evaluate cosmesis

incidence of moderate to severe capsular contracture

rates of minor revisional surgeries

Trial Design

2Treatment groups

Experimental Treatment

Group I: Group 2Experimental Treatment3 Interventions

Physical examination by MD, optional Breast MRI, Breast-Q © at baseline (after permanent implant exchange and after IMRT), 18 ± 2 months and 30 ± 2 months post-IMRT, as these patients will undergo exchange of the temporary expander for the permanent implant approximately 4-8 months following the completion of radiation (at the discretion of the treating plastic surgeon). Total length of the follow-up time will be 30 ± 2 months post-IMRT

Group II: Group 1Experimental Treatment3 Interventions

Physical examination by MD, optional Breast MRI, Breast-Q© at baseline (after permanent implant exchange, physical exam and Breast-Q© may be done after the initiation of IMRT), 12 ± 2 months and 24 ± 2 months post- IMRT. Total length of the follow-up time will be 24 ± 2 months post-IMRT. A subset of 10 left-sided patients will receive 13N-NH3 PET scans within the radiation simulation session. A CT for coronary calcium scoring and a low-dose CT for attenuation correction will also be obtained at this time. Myocardial blood flow will be measured during rest and at peak stress with 13N-NH3 as a perfusion tracer. A follow-up 13N-NH3 PET study with low-dose CT for attenuation correction will be obtained 12-18 months (± 6 months) post-IMRT.

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,933 Previous Clinical Trials

585,498 Total Patients Enrolled

202 Trials studying Breast Cancer

81,013 Patients Enrolled for Breast Cancer

Daphna Gelblum, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

48 Total Patients Enrolled

Media Library

Multi-Beam IMRT (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02086578 — Phase 2

Breast Cancer Research Study Groups: Group 1, Group 2

Breast Cancer Clinical Trial 2023: Multi-Beam IMRT Highlights & Side Effects. Trial Name: NCT02086578 — Phase 2

Multi-Beam IMRT (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02086578 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any sites in North America currently engaged with this clinical research?

"This clinical trial is being administered at 7 different medical sites, including Memorial Sloan Kettering's Mercy Medical Center in Rockville Centre and Uniondale (follow-up only) as well as the Harrison location of Memorial Sloan Kettering Westchester. There are also other four additional locations."

Answered by AI

Is this experiment currently accepting applicants?

"This medical study, which was initially posted on March 11th 2014 and last updated April 1st 2022 is not seeking any new patients at present. However, other trials hosted on clinicaltrials.gov are actively recruiting with a combined total of 2596 studies looking for volunteers."

Answered by AI

"The observed safety of the Breast-Q© questionnaire has been assessed as a 2, since data supports its security but there is no empirical evidence for efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2014. "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". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02086578.