NCT05288777 Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
| NCT ID | NCT05288777 |
| Status | Recruiting |
| Phase | Phase 2, Phase 3 |
| Sponsor | University of Virginia |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 45 participants |
| Start Date | 2022-07-11 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 45 participants in total. It began in 2022-07-11 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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.
Contact & Investigator
Einsley Janowski, MD, PhD
PRINCIPAL INVESTIGATOR
University of Virginia
Frequently Asked Questions
Who can join the NCT05288777 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05288777 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05288777 currently recruiting?
Yes, NCT05288777 is actively recruiting participants. Contact the research team at stw2g@hscmail.mcc.virginia.edu for enrollment information.
Where is the NCT05288777 trial being conducted?
This trial is being conducted at Charlottesville, United States.
Who is sponsoring the NCT05288777 clinical trial?
NCT05288777 is sponsored by University of Virginia. The principal investigator is Einsley Janowski, MD, PhD at University of Virginia. The trial plans to enroll 45 participants.
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