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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 belowSelect...
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.
Select...
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
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
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.
Postmastectomy radiotherapy using three different techniques: a retrospective evaluation of the incidental dose distribution in the internal mammary nodes.
Find a Location
Who is running the clinical trial?
Memorial Sloan Kettering Cancer CenterLead Sponsor
1,964 Previous Clinical Trials
596,827 Total Patients Enrolled
206 Trials studying Breast Cancer
83,875 Patients Enrolled for Breast Cancer
Daphna Gelblum, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
89 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast cancer diagnosis was confirmed by MSKCC.I haven't had breast reconstruction before radiation, but may have a tissue expander.I am a woman over 18 and expected to live at least 2 more years.My recommended radiation therapy will target specific areas near my breast.I am fully active or can carry out light work.I have had a mastectomy and my underarm lymph nodes were checked.I have had radiation therapy on the same side of my chest before.I had immediate breast reconstruction with an implant or expander before radiation at MSKCC.
Research Study Groups:
This trial has the following groups:- Group 1: Group 1
- Group 2: Group 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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