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
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Questionnaires
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "Participants will also be asked to complete surveys asking about overall health and wellbeing."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Official eligibility criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Male or female, aged 18 or older 4. Diagnosis of stage I-IIIB breast cancer 5. Received neoadjuvant chemotherapy (minimum of 3 cycles) and surgical resection (lumpectomy and/or mastectomy) 6. Discovered to have residual disease at least ypT1aNx or ypTxN1mic at surgical resection 7. Candidate for adjuvant chemoradiation as part of standard clinical care 8. Planned initiation of radiation within 12 weeks of their final oncologic surgery 9. ECOG performance status ≤2 10. Adequate cardiac function, with LVEF greater or equal to 45% (only for patients who will receive TDM-1 therapy) 11. Adequate organ function per the following criteria within 21 days before the start of treatment. If a laboratory value required for study eligibility does not meet the below requirements, the value may be retested. * Absolute neutrophil count ≥1.5 k/uL * Platelets ≥100 k/uL * Hemoglobin ≥ 10 g/dL * Serum Creatinine ≤ 1.5 x ULN * Bilirubin ≤ 1.5 x ULN (except in patients with Gilbert's disease, where bilirubin to 4x ULN is allowed). * AST and ALT ≤ 2.5 x ULN * Alkaline phosphatase ≤ 2.5 x ULN 12. For females and males of reproductive potential: agreement to use adequate contraception during study participation and for an additional 6 months after the end of chemoradiation administration or until advised by their medical oncologist 13. Agreement to adhere to Lifestyle Considerations throughout study duration 14. Subjects taking warfarin and plan to receive capecitabine will need their anticoagulant management assessed before starting treatment. Exclusion Criteria: 1. Had a mastectomy with expander placement or immediate reconstructions 2. Diagnosed with systemic lupus 3. Diagnosed with scleroderma 4. Diagnosed with a genetic mutation associated with increased sensitivity to radiation (e.g. ataxia-telangectasias (AT)). AT heterozygotes without known radiation sensitivity may be included. 5. Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration. 6. Pathologic evidence of metastatic disease, or strong clinical/radiological evidence of metastatic disease, at the investigator's judgment. 7. Pregnancy or lactation 8. Incarceration 9. Presence of cardiac pacemaker on side of the body that is being treated unless the pacemaker can be moved prior to treatment. 10. Anthracycline exposure exceeding a cumulative doxorubicin dose of 264 mg/m2 (240 mg/m2 plus a 10% threshold) 11. Known allergic reactions to components of capecitabine or T-DM1 12. Known DPD deficiency for patients prescribed capecitabine 13. Febrile illness within a week of starting treatment 14. Incomplete healing of chest wall or breast in the treatment field within 12 weeks from surgery. 15. Known HIV or active hepatitis. 16. Unwilling to discontinue endocrine therapy if currently taking endocrine therapy.
Study sites (1)
VA
- University of Virginia · Charlottesville, VA 22903Song Wood · Study contact · 434 243 0008 · stw2g@hscmail.mcc.virginia.eduEinsley Janowski, Md, PhD · Principal investigatorMore trials in Charlottesville