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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

Must not have

Cohort B1/B2: Radiologic evidence for a stage T2-T3 or clinical stage T4 breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 years

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

My breast cancer is at stage T2-T3 or clinically at stage T4.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Ipsilateral breast tumor recurrence-free survival (IBT-RFS)

Overall survival

Other study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Cohort DExperimental Treatment1 Intervention

* Optional biopsy for nanomechanical biomarker assessment * Chart review every year after surgery for 5 years * Eligible patients who have undergone the optional biopsy may later move to Cohort A or C if they meet all eligibility requirements and desire radiation omission.

Group II: 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 III: 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 IV: 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

Whole Breast Irradiation

2017

N/A

~160

External Beam Radiation Therapy

2006

Completed Phase 3

~3300