Status:
RECRUITING
Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
Lead Sponsor:
University of Virginia
Conditions:
Breast Cancer
Breast Cancer Stage I
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
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 lumpect...
Detailed Description
Breast cancer is often treated with a combination of surgery, chemotherapy and radiation. In patients with advanced breast cancer, (neoadjuvant) chemotherapy is often given prior to surgical removal (...
Eligibility Criteria
Inclusion
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 or older
- Diagnosis of stage I-IIIB breast cancer
- Received neoadjuvant chemotherapy (minimum of 3 cycles) and surgical resection (lumpectomy and/or mastectomy)
- Discovered to have residual disease at least ypT1aNx or ypTxN1mic at surgical resection
- Candidate for adjuvant chemoradiation as part of standard clinical care
- Planned initiation of radiation within 12 weeks of their final oncologic surgery
- ECOG performance status ≤2
- Adequate cardiac function, with LVEF greater or equal to 45% (only for patients who will receive TDM-1 therapy)
- 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
- 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
- Agreement to adhere to Lifestyle Considerations throughout study duration
- Subjects taking warfarin and plan to receive capecitabine will need their anticoagulant management assessed before starting treatment.
Exclusion
- Had a mastectomy with expander placement or immediate reconstructions
- Diagnosed with systemic lupus
- Diagnosed with scleroderma
- 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.
- Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration.
- Pathologic evidence of metastatic disease, or strong clinical/radiological evidence of metastatic disease, at the investigator's judgment.
- Pregnancy or lactation
- Incarceration
- Presence of cardiac pacemaker on side of the body that is being treated unless the pacemaker can be moved prior to treatment.
- Anthracycline exposure exceeding a cumulative doxorubicin dose of 264 mg/m2 (240 mg/m2 plus a 10% threshold)
- Known allergic reactions to components of capecitabine or T-DM1
- Known DPD deficiency for patients prescribed capecitabine
- Febrile illness within a week of starting treatment
- Incomplete healing of chest wall or breast in the treatment field within 12 weeks from surgery.
- Known HIV or active hepatitis.
- Unwilling to discontinue endocrine therapy if currently taking endocrine therapy.
Key Trial Info
Start Date :
July 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05288777
Start Date
July 11 2022
End Date
December 1 2029
Last Update
April 18 2025
Active Locations (1)
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1
University of Virginia
Charlottesville, Virginia, United States, 22903