Actively Recruiting
A Study of Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
Led by University of Virginia · Updated on 2025-04-18
45
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of adjuvant chemoradiation therapy in high-risk breast cancer patients who have residual disease after receiving neoadjuvant chemotherapy and surgery. The study also aims to examine how this treatment affects the immune system. This research focuses on breast cancer stages I to IIIB and seeks to improve outcomes in patients at increased risk of recurrence. Participants will receive treatment based on their HER2 status. Those who are HER2 positive will receive T-DM1 (trastuzumab emtansine) infusions every three weeks for up to 14 cycles alongside radiation therapy to the breast or chest wall and lymph nodes. HER2 negative patients will take oral capecitabine twice daily for six months while also receiving radiation. Radiation doses are given in 15 fractions over 15 to 19 days, with possible additional boosts depending on the treatment area. The study includes different groups based on HER2 status and lymph node involvement. During the study, participants will have blood samples collected at multiple times to monitor immune responses and will complete surveys about their overall health and wellbeing. Researchers will assess safety by monitoring treatment side effects and delays over one year. They will also evaluate cosmetic outcomes of radiation using specific scales and breast measurements. The study runs until December 2029, with close follow-up to understand treatment feasibility and impact on patient health.
CONDITIONS
Brief Title
Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent form
- Willingness to comply with all study procedures and be available for the full study duration
- Male or female aged 18 years or older
- Diagnosis of stage I to IIIB breast cancer
- Received at least 3 cycles of neoadjuvant chemotherapy and surgical resection (lumpectomy and/or mastectomy)
- Residual disease found at surgery with at least ypT1aNx or ypTxN1mic
- Candidate for adjuvant chemoradiation as standard care
- Planned to start radiation within 12 weeks after final cancer surgery
- ECOG performance status of 2 or less
- Adequate cardiac function with LVEF ≥ 45% for patients receiving T-DM1
- Adequate organ function within 21 days before treatment start with specified blood count and liver/kidney function levels
- Agreement to use effective contraception during and for 6 months after chemoradiation
- Commitment to lifestyle considerations during the study
- Anticoagulant management assessment if taking warfarin and prescribed capecitabine
You will not qualify if you...
- Underwent mastectomy with expander placement or immediate reconstruction
- Diagnosed with systemic lupus or scleroderma
- Genetic mutation causing increased radiation sensitivity (e.g., ataxia-telangiectasia), except AT heterozygotes without known sensitivity
- Acute bacterial or fungal infection requiring IV antibiotics at registration
- Evidence of metastatic disease by pathology or clinical judgment
- Pregnant or breastfeeding
- Incarcerated individuals
- Cardiac pacemaker on the treated side unless it can be moved before treatment
- Prior anthracycline exposure exceeding cumulative dose of 264 mg/m2
- Known allergy to capecitabine or T-DM1 components
- Known DPD deficiency if prescribed capecitabine
- Febrile illness within one week before starting treatment
- Incomplete healing of chest wall or breast in treatment area within 12 weeks from surgery
- Known HIV infection or active hepatitis
- Unwillingness to stop endocrine therapy if currently taking it during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months for capecitabine or up to 14 cycles of T-DM1 (approximately 42 weeks) with concurrent radiation lasting 15 to 19 days
Participants receive adjuvant chemoradiation therapy after surgery, combining chemotherapy (T-DM1 infusion or oral capecitabine) with radiation to the breast or chest wall and possibly lymph nodes depending on their Her2/neu and lymph node status.
Weekly visits for radiation over 3 weeks plus chemotherapy visits every 3 weeks for T-DM1 or twice daily oral medication for capecitabine
Duration - Up to 1 year
Participants have blood drawn and complete health and wellbeing surveys to assess safety, feasibility, and cosmetic outcomes up to 1 year after treatment.
Approximately 6 follow-up visits post-treatment
Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
S
Song Wood
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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