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External Beam Radiation
Preoperative APBI for Breast Cancer
N/A
Waitlist Available
Led By Adam Currey, MD
Research Sponsored by Medical College of Wisconsin
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically proven diagnosis of invasive breast cancer, clinically stage I-II
Female
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
Study Summary
This trial is studying if it's feasible to give accelerated partial breast irradiation (APBI) before a lumpectomy. APBI is when a smaller volume of breast tissue is exposed to radiation. The trial is using 3D conformal external beam irradiation, which uses an X-ray beam to deliver the radiation dose. MRI will be used to plan the treatment instead of CT imaging.
Who is the study for?
This trial is for women over 40 with early-stage breast cancer (stage I-II), who have not been treated yet. They must be estrogen receptor positive, and can have either her2 positive or negative tumors. Participants should not be pregnant, willing to use contraception during radiation therapy, and without a history of certain other cancers or severe health conditions.Check my eligibility
What is being tested?
The study tests if giving accelerated partial breast irradiation (APBI) using MRI before lumpectomy surgery is feasible. This could mean less breast tissue gets exposed to radiation compared to traditional methods where APBI follows the surgery.See study design
What are the potential side effects?
Potential side effects may include skin changes like redness and irritation at the treatment site, fatigue, discomfort in the breast area, and rare risks associated with MRI such as allergic reactions to contrast material used during imaging.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is confirmed and is in the early stages (I or II).
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I am female.
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My cancer is estrogen receptor positive.
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My condition involves only one area or organ.
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I was diagnosed with invasive ductal carcinoma through a biopsy.
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My lymph nodes are normal on exams and ultrasound, with any suspicious ones biopsied.
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I can take care of myself and am up more than 50% of my waking hours.
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I've had a full check-up, breast exams, mammograms, and lymph node checks for breast cancer with no signs of it spreading far.
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I am 40 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Postoperative Complications Following
Secondary outcome measures
Overall Survival
Re-excision of Tumor.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Radiation Therapy followed by LumpectomyExperimental Treatment1 Intervention
Phase II-Preoperative MRI-BasedRadiation followed by Lumpectomy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Phase II - Preoperative Radiation followed by Lumpectomy.
2009
N/A
~40
Find a Location
Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
609 Previous Clinical Trials
1,162,544 Total Patients Enrolled
13 Trials studying Breast Cancer
409,304 Patients Enrolled for Breast Cancer
Adam Currey, MDPrincipal InvestigatorMedical College of Wisconsin
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your doctor thinks you have 10 years or less to live.My cancer is not driven by estrogen.Signs of cancer spreading through the lymph or blood vessels were found in the biopsy.You cannot have an MRI if you have a severe allergy to the contrast used, or if your kidney function is too low to handle the contrast. If you have a mild allergy to the contrast, you might still be able to join the study if you follow a specific treatment plan.My recent blood test shows I have enough neutrophils, platelets, and hemoglobin.I've been cancer-free from previous cancers, except skin, cervical, or opposite breast cancer, for over 5 years.I had cancer in my other breast but finished all treatments over five years ago.My breast cancer is at an advanced stage (IIB, III, or IV).My breast cancer is non-invasive.My breast cancer is not the common type but rather a rare form like sarcoma or lymphoma.I have had breast augmentation or implants.I have breast cancer in more than one location.My breast cancer is aggressive (grade 3).I've had radiation therapy in the same chest area before.I am receiving or planning to receive chemotherapy before or with surgery, but not due to a high Oncotype score.I have a known BRCA gene mutation.I do not have severe health issues like recent heart problems, serious infections, or liver problems.I was diagnosed with invasive ductal carcinoma through a biopsy.My lymph nodes are normal on exams and ultrasound, with any suspicious ones biopsied.I can take care of myself and am up more than 50% of my waking hours.I was diagnosed with breast cancer less than 120 days ago.My cancer's hormone receptor status and HER2 status have been tested according to ASCO/CAP guidelines.I've had a full check-up, breast exams, mammograms, and lymph node checks for breast cancer with no signs of it spreading far.My breast cancer is confirmed and is in the early stages (I or II).My cancer is estrogen receptor positive.My cancer can be HER2 positive or negative.My condition involves only one area or organ.I am female.I haven't been treated for cancer (except some skin, cervical, or opposite breast cancers) in the last 5 years.I am willing to meet with an oncologist and consider chemotherapy if my Oncotype test suggests it.I have a connective tissue disorder like lupus.I have Paget's disease of the nipple.My breast cancer is invasive lobular carcinoma.I need considerable assistance and frequent medical care.I am a male diagnosed with breast cancer.I am 40 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Radiation Therapy followed by Lumpectomy
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings for those wishing to participate in this medical experiment?
"The records on clinicaltrials.gov demonstrate that this study is not presently enrolling any new participants. The original posting date was July 29th 2016 and the most recent amendments were made August 1st 2022, however over two thousand six hundred other trials are currently looking for volunteers at this moment in time."
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