NCT05288777 · University of Virginia
Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
(Breast53)
What this study 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.
View original scientific description
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.
Interventions
DRUG
T-DM1
Dosed at 3.6 mg/kg of body weight every 3 weeks for Her2/neu+ patients for a total duration of 14 cycles.
DRUG
Capecitabine
Dosed at 825 mg/m2 +/- 150mg twice per day for a total duration of 6 months
RADIATION
External Beam Radiation Therapy 0
Dose of 40 Gy in 15 fractions to the whole breast or chest wall followed by consideration of a 10 Gy in 4 fraction boost to the lumpectomy cavity for a total duration of 15-19 days. Internal mammary nodal, dissected axilla coverage, and boost will be at the radiation oncologist's discretion.
RADIATION
External Beam Radiation Therapy 1
Dose of 40 Gy in 15 fractions to either the breast or chest wall along with comprehensive nodal radiation followed by consideration of a 10 Gy in 4 fraction boost for a total duration of 15-19 days. Internal mammary nodal, dissected axilla coverage, and boost will be at the radiation oncologist's discretion.
Primary outcome measures
Assess safety via toxicity grading
Time frame: 1 year
Assessment of toxicity frequency and severity using CTCAE v5.0 adverse event grading scale throughout chemoradiation treatment and follow up.
Assess feasibility via treatment delays and completion
Time frame: 1 year
Percent of participants completing adjuvant chemoradiation therapy and percent of participants requiring radiation or chemotherapy dose delays.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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 criteria
- 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.
Where
- Charlottesville, Virginia
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 18, 2025 · Source of record for eligibility and locations