RecruitingPhase 2Phase 3NCT05288777

Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer

A Study of Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer


Sponsor

University of Virginia

Enrollment

45 participants

Start Date

Jul 11, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this study is to evaluate the safety and effectiveness of adjuvant chemoradiation therapy in high-risk breast cancer patients who had received neoadjuvant chemotherapy before their lumpectomy and/or mastectomy and were found to have residual disease. As well as examine the effects of this treatment combination on the immune system.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study examines biological markers in people with high-risk breast cancer who received chemotherapy before surgery (neoadjuvant chemotherapy) but still had cancer remaining after surgery. These patients then receive additional radiation and/or chemotherapy, and the study tracks how well they respond. **You may be eligible if...** - You are 18 or older (male or female) - You have been diagnosed with stage I–IIIB breast cancer - You received at least 3 cycles of chemotherapy before surgery - Cancer was still found in your breast or lymph nodes after surgery - You are scheduled to receive additional radiation as part of your standard care - Your radiation is planned to start within 12 weeks of your last surgery - Your heart function (ejection fraction) is at least 45% if you will receive a drug called TDM-1 **You may NOT be eligible if...** - Your breast cancer was fully eliminated by pre-surgery chemotherapy - You have significant heart problems or other serious organ issues - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGT-DM1

Dosed at 3.6 mg/kg of body weight every 3 weeks for Her2/neu+ patients for a total duration of 14 cycles.

DRUGCapecitabine

Dosed at 825 mg/m2 +/- 150mg twice per day for a total duration of 6 months

RADIATIONExternal Beam Radiation Therapy 0

Dose of 40 Gy in 15 fractions to the whole breast or chest wall followed by consideration of a 10 Gy in 4 fraction boost to the lumpectomy cavity for a total duration of 15-19 days. Internal mammary nodal, dissected axilla coverage, and boost will be at the radiation oncologist's discretion.

RADIATIONExternal Beam Radiation Therapy 1

Dose of 40 Gy in 15 fractions to either the breast or chest wall along with comprehensive nodal radiation followed by consideration of a 10 Gy in 4 fraction boost for a total duration of 15-19 days. Internal mammary nodal, dissected axilla coverage, and boost will be at the radiation oncologist's discretion.


Locations(1)

University of Virginia

Charlottesville, Virginia, United States

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NCT05288777


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