What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as radiation therapy, chemotherapy, and hormonal therapy, have various side effects. Radiation therapy, including advanced techniques like Multi-beam Intensity Modulated Radiation Therapy (IMRT), can cause skin irritation, fatigue, and, less commonly, damage to surrounding tissues such as the heart and lungs. Chemotherapy often leads to side effects like nausea, hair loss, fatigue, and increased risk of infections. Hormonal therapies can result in hot flashes, joint pain, and bone density loss. IMRT specifically aims to reduce radiation exposure to surrounding tissues, potentially lowering the risk of these side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that aim to improve precision and reduce side effects, similar to the goals of Multi-beam Intensity Modulated Radiation Therapy (IMRT). Traditional radiation therapies like 3D conformal radiation therapy have been standard, but newer techniques such as IMRT offer more customized radiation doses to minimize exposure to surrounding tissues and reduce complications, especially in patients with implant reconstructions. Additionally, systemic therapies like trastuzumab and its biosimilars have been approved for HER2-positive breast cancer, enhancing targeted treatment options. These advancements collectively aim to improve patient outcomes and quality of life by reducing treatment-related side effects.

What other types of research exist?

Promising novel alternatives to Multi-beam IMRT for breast cancer patients include: 1) Proton Beam Therapy, which uses protons instead of X-rays to deliver precise radiation doses with minimal exposure to surrounding tissues; 2) Stereotactic Body Radiotherapy (SBRT), which delivers highly focused radiation in fewer sessions with high precision; and 3) Adaptive Radiation Therapy (ART), which adjusts the radiation plan in real-time based on changes in the patient's anatomy or tumor size during treatment. These methods aim to enhance treatment efficacy while reducing side effects.

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Radiation Therapy

IMRT for Breast Cancer with Implants

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

Must not have

Prior radiation therapy to the ipsilateral breast/nodes or thorax.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new radiation treatment called Multi-beam IMRT for women with implants after mastectomy. The treatment uses multiple small beams to target the area more precisely, aiming to reduce side effects and protect healthy tissues.

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.

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.

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.

Select...

My breast cancer diagnosis was confirmed by MSKCC.

Select...

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

Select...

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had radiation therapy on the same side of my chest before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

efficacy of multi-beam IMRT

Secondary study objectives

evaluate cosmesis

incidence of moderate to severe capsular contracture

rates of minor revisional surgeries

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Breast MRI

2014

Completed Phase 2

~130

Breast-Q© questionnaire

2014

Completed Phase 2

~130

Multi-Beam IMRT

2014

Completed Phase 2

~130

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Breast cancer treatments include surgery, chemotherapy, hormone therapy, and radiation therapy. Multi-beam Intensity Modulated Radiation Therapy (IMRT) is a specialized form of radiation therapy that delivers a customized dose of radiation to the tumor using multiple small beams, reducing exposure to surrounding healthy tissues and minimizing side effects, especially important for patients with implants. This precision helps in preserving the quality of life by reducing complications such as damage to the heart and lungs. Surgery removes the tumor, chemotherapy kills rapidly dividing cancer cells, and hormone therapy blocks hormones that fuel cancer growth. These treatments collectively aim to eradicate cancer while minimizing harm to the patient.

Postmastectomy radiotherapy using three different techniques: a retrospective evaluation of the incidental dose distribution in the internal mammary nodes.