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Radiation Therapy After Systemic Therapy for Breast Cancer
N/A
Recruiting
Led By Henry M Kuerer
Research Sponsored by M.D. Anderson Cancer 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 years
Awards & highlights
Study Summary
This trial is testing whether eliminating surgery and just using radiation therapy after systemic therapy works well in treating patients with HER2 positive or triple negative breast cancer.
Who is the study for?
This trial is for women aged 40+ with HER2 positive or triple negative breast cancer, stages T1-T2 and N0-N1, who want to avoid surgery. It's also open to those with specific types of hormone receptor-positive breast cancer meeting Oncotype criteria. Participants must not have had prior invasive breast treatments or show signs of advanced disease.Check my eligibility
What is being tested?
The study tests if radiation therapy can replace surgery after systemic therapy in patients showing no residual cancer on biopsy. It includes external beam radiation, biomarker analysis, quality-of-life assessments, and questionnaires to evaluate the effectiveness of this approach.See study design
What are the potential side effects?
Potential side effects from radiation may include skin irritation, fatigue, swelling in treated areas (lymphedema), changes in breast shape or size, pain or stiffness in the shoulder area, and a slight risk of secondary cancers.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ipsilateral breast tumor recurrence-free survival (IBT-RFS)
Overall survival
Other outcome measures
Change in biomarkers in blood and plasma
Incidence of ipsilateral breast and nodal recommendation and performance of biopsy based on breast imaging follow-up
Quality of Life measured by BCTOS questionnaire
+3 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Cohort CExperimental Treatment5 Interventions
Optional biopsy for nanomechanical biomarker assessment
Neoadjuvant chemotherapy therapy
Surgery (& optional biopsy nanomechanical biomarker assessment): if no disease remaining - stay on the study and skip radiation
H&P and Imaging every 6 months
Group II: Cohort BExperimental Treatment5 Interventions
Neoadjuvant endocrine therapy for 6 months
Radiation if there is less than 25% tumor increase
Biopsy: if negative - additional endocrine therapy under the guidance of medical oncologist (skip breast surgery)
H&P and Imaging every 6 months
Cohort B Radiation:
Treatment (Stereotactic ablative radiotherapy -SABR) Following 3-6 months of endocrine therapy, if less than 25% tumor increase, patients undergo SABR irradiation over 10 fractions every other business day.
Group III: Cohort AExperimental Treatment5 Interventions
Neoadjuvant chemotherapy therapy
Biopsy: if no disease remaining - stay on the study and receive radiation (skip breast surgery)
H&P and Imaging every 6 months
Treatment (whole breast irradiation, EBRT) Within 12 weeks of completing neoadjuvant systemic therapy, patients undergo whole breast irradiation over 15-25 fractions on consecutive days. Patients then undergo EBRT boost over 7 fractions on consecutive days beginning the day following completion of whole breast irradiation.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
External Beam Radiation Therapy
2006
Completed Phase 3
~3150
Whole Breast Irradiation
2017
N/A
~160
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,986 Previous Clinical Trials
1,789,482 Total Patients Enrolled
148 Trials studying Breast Cancer
63,277 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,708 Previous Clinical Trials
40,932,609 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
Henry M KuererPrincipal InvestigatorM.D. Anderson Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman over 40 with a specific type of early-stage breast cancer, interested in hormone therapy and breast-saving treatment, with no prior breast radiation.I have advanced breast cancer with signs of spreading and no current pregnancy.I am a woman over 30 with early-stage, HER2 positive breast cancer or over 50 with triple-negative breast cancer, seeking breast conserving therapy.I am a woman over 40 with a specific type of breast cancer, wanting to save my breast, and have treated any other cancers.My breast cancer is at stage T2-T3 or clinically at stage T4.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort C
- Group 2: Cohort A
- Group 3: Cohort B
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 researchers enrolling people in this clinical trial at this time?
"This trial is still recruiting patients, with the latest update having been on September 27th, 2022. The original posting date was January 20th, 2017."
Answered by AI
Are other research hospitals in Canada also administering this trial?
"Patients are being recruited for this study at Mayo Clinic in Rochester, Minnesota; M D Anderson Cancer Center in Houston, Texas; Baptist MD Anderson Cancer Center in Jacksonville, Florida; and six additional sites."
Answered by AI
How many total enrollees are in this clinical research program?
"To run this study successfully, we need 120 patients that fit the given inclusion criteria. Some of the places where patients can participate in this trial include Mayo Clinic in Rochester, Minnesota and M D Anderson Cancer Center in Houston, Texas."
Answered by AI
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