← Back to Search

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 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

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 more

Trial 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
3,002 Previous Clinical Trials
1,794,159 Total Patients Enrolled
148 Trials studying Breast Cancer
63,277 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,743 Previous Clinical Trials
40,957,727 Total Patients Enrolled
944 Trials studying Breast Cancer
1,544,008 Patients Enrolled for Breast Cancer
Henry M KuererPrincipal InvestigatorM.D. Anderson Cancer Center

Media Library

Quality-of-Life Assessment Clinical Trial Eligibility Overview. Trial Name: NCT02945579 — N/A
Breast Cancer Research Study Groups: Cohort C, Cohort A, Cohort B
Breast Cancer Clinical Trial 2023: Quality-of-Life Assessment Highlights & Side Effects. Trial Name: NCT02945579 — N/A
Quality-of-Life Assessment 2023 Treatment Timeline for Medical Study. Trial Name: NCT02945579 — N/A
~21 spots leftby Jan 2026