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Radiation Omission for Breast Cancer
N/A
Waitlist Available
Led By Shane Stecklein, MD, PhD
Research Sponsored by University of Kansas Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 year post-op
Awards & highlights
Study Summary
This trial is testing how well lumpectomy and chemotherapy work in treating HER2-positive early stage breast cancer.
Eligible Conditions
- HER2-positive Breast Cancer
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 year post-op
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 year post-op
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Local Control Rate
Secondary outcome measures
Cosmetic (Breast) Outcomes
Distance Metastasis
Lymphedema Rate
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm AExperimental Treatment1 Intervention
Patient is required to have lumpectomy with sentinel lymph node biopsy shows pCR and will complete 1 year of trastuzumab +/- pertuzumab treatment. No radiation, or an omission of radiation, will be given on this arm, including external beam, brachytherapy or intraoperative radiation. Patients will be required to follow up with a medical, surgical, or radiation oncologist every 3 months for 5 years. At these follow up visits, a physical exam will be performed to assess for any disease recurrence. Screening mammogram or MRI is recommended every 6 months for patients on this arm.
Group II: Arm BActive Control1 Intervention
Patient is required to have her-2 positive breast cancer, clinically node negative from exam. Patient will complete neoadjuvant chemotherapy per Medical Oncologist. This arm will undergo lumpectomy with sentinel lymph node biopsy shows pCR. The patient will proceed with radiation as standard of care. This arm includes a review of outcomes in the patient's medical chart as well as a collection of biospecimens such as blood and urine, for correlative studies.
Group III: Arm CActive Control1 Intervention
Patient is required to have her-2 positive breast cancer, clinically node negative from exam. patient will complete neoadjuvant chemotherapy per Medical Oncologist. This arm will not undergo lumpectomy with sentinel lymph node biopsy shows pCR. The patient will proceed with radiation as standard of care. This arm includes a review of outcomes in the patient's medical chart as well as a collection of biospecimens, such as blood and urine, for correlative studies.
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Who is running the clinical trial?
University of Kansas Medical CenterLead Sponsor
461 Previous Clinical Trials
169,145 Total Patients Enrolled
23 Trials studying Breast Cancer
4,510 Patients Enrolled for Breast Cancer
Shane Stecklein, MD, PhDPrincipal InvestigatorUniversity of Kansas Medical Center
1 Previous Clinical Trials
389 Total Patients Enrolled
1 Trials studying Breast Cancer
389 Patients Enrolled for Breast Cancer
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your Her-2 test results show a high level of a specific protein or gene.Only women who have gone through menopause will be eligible. This means they have not had a period for at least one year, have had both ovaries removed, or have specific hormone levels as per the clinic's standards.You have been diagnosed with a disease that has spread to other parts of your body.You have had a cancer diagnosis, except for certain types of skin cancer, and have been cancer-free for at least 5 years.The scar tissue from a previous tumor is at least 3 millimeters away from where the surgery was done.You have been diagnosed with inflammatory breast cancer.The size of the tumor should not be bigger than 5 cm when reviewed by a pathologist.There are no signs that the lymph nodes have changed due to previous treatment.Women who are 40 years old or older and have been diagnosed with invasive ductal carcinoma.The examination of the tumor area shows no remaining signs of cancer.You have already had chemotherapy with trastuzumab before surgery and plan to continue taking trastuzumab for a year.Your cancer is in the early stages and has not spread to nearby lymph nodes.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A
- Group 2: Arm B
- Group 3: Arm C
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.
Is there still an opportunity to participate in this research endeavor?
"Affirmative. Documents hosted on clinicaltrials.gov verify that this trial is recruiting participants, having been first posted on February 23rd 2018 and last modified May 8th 2021. The study aims to enroll 78 patients from one medical site."
Answered by AI
What is the projected population size for this research endeavor?
"Affirmative, clinicaltrials.gov holds the information that this medical experiment is still recruiting participants. The trial was first released on February 23rd 2018 and its parameters were most recently amended on May 8th 2021. 78 people are required to be enrolled across a single centre for this study to reach completion."
Answered by AI
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