Actively Recruiting
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
385 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form
- Willingness to comply with all study procedures and be available for the 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)
- Presence of residual disease at surgical resection (at least ypT1aNx or ypTxN1mic)
- Candidate for adjuvant chemoradiation as standard care
- Planned start of radiation within 12 weeks after final surgery
- ECOG performance status of 2 or less
- Adequate cardiac function with LVEF 45% or higher for those receiving T-DM1
- Adequate organ function based on blood tests within 21 days before treatment
- Agreement to use contraception during the study and for 6 months after treatment if of reproductive potential
- Agreement to follow lifestyle considerations during the study
- Assessment of anticoagulant management if taking warfarin and receiving capecitabine
You will not qualify if you...
- Mastectomy with expander placement or immediate reconstruction
- Diagnosis of systemic lupus or scleroderma
- Genetic mutations causing increased radiation sensitivity (e.g., ataxia-telangiectasias), except AT heterozygotes without radiation sensitivity
- Acute bacterial or fungal infection requiring IV antibiotics at registration
- Evidence of metastatic disease by pathology or clinical judgment
- Pregnancy or breastfeeding
- Incarceration
- Cardiac pacemaker on the treated side unless it can be moved prior to treatment
- Excessive prior anthracycline exposure (doxorubicin dose over 264 mg/m2)
- Known allergies to capecitabine or T-DM1 components
- Known DPD deficiency for patients prescribed capecitabine
- Febrile illness within a week before starting treatment
- Incomplete healing of chest wall or breast in treatment area within 12 weeks post-surgery
- Known HIV infection or active hepatitis
- Unwillingness to stop endocrine therapy if currently taking it
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
S
Song Wood
CONTACT
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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