Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
T-DM1
DrugDosed at 3.6 mg/kg of body weight every 3 weeks for Her2/neu+ patients for a total duration of 14 cycles.
Capecitabine
DrugDosed at 825 mg/m2 +/- 150mg twice per day for a total duration of 6 months
External Beam Radiation Therapy 0
RadiationDose 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.
External Beam Radiation Therapy 1
RadiationDose 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.
Treatment groups
45 Participants
are divided into 4 treatment groupsGroup A: Her2/neu positive and lymph node positiveOther 2 interventions
Group B: Her2/neu positive and lymph node negativeOther 2 interventions
Group C: Her2/neu negative and lymph node positiveOther 2 interventions
Group D: Her2/neu negative and lymph node negativeOther 2 interventions
Trial outcomes
Primary outcomes
1
Assess safety via toxicity grading
Assessment of toxicity frequency and severity using CTCAE v5.0 adverse event grading scale throughout chemoradiation treatment and follow up.
Time frame
1 year2
Assess feasibility via treatment delays and completion
Percent of participants completing adjuvant chemoradiation therapy and percent of participants requiring radiation or chemotherapy dose delays.
Time frame
1 yearSecondary outcomes
1
Assess chronic cosmetic outcomes via LENT-SOMA scale
Assessment of chronic radiation-related cosmetic outcomes (e.g. dermatitis, telangiectasia, pigmentation, and radiation fibrosis) using "Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA)" scale throughout chemoradiation treatment and follow up. Each side effect is graded on a scale of 0 to 4, with higher scores meaning more severe outcome.
Time frame
1 year2
Assess acute cosmetic outcomes via RTOG/EORTC scale
Assessment of overall acute radiation related skin changes using the "Toxicity Criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC)" grading scale throughout chemoradiation treatment and follow up. Each side effect is graded on a scale of 0 to 4, with higher scores meaning more severe outcome.
Time frame
1 year3
Assess cosmetic outcomes via breast measurements
Measurement of breast tissue size by measuring tape/ruler.
Time frame
1 yearOther outcomes
1
Estimate recurrence-free survival
Recurrence-free survival after 1 year of adjuvant chemoradiation therapy.
Time frame
1 year2
Describe the amount and type of immune cells via lab tests
Lab analysis (CBC w/ Differential and ELISA assays) of blood to characterize and count leukocyte populations (neutrophils, monocytes, lymphocytes) throughout adjuvant chemoradiation treatment and follow up.
Time frame
1 year3
Assess quality of life via RAND SF-36 patient survey
RAND SF-36 survey assesses feelings on overall health and activity level during follow up after adjuvant chemoradiation treatment.
Time frame
1 year4
Assess quality of life via FACT-B patient survey
Functional Assessment of Cancer Therapy- Breast (FACT-B) survey generally assess physical wellbeing, Social wellbeing, emotional wellbeing and functional well being during follow up after adjuvant chemoradiation treatment.
Time frame
1 yearSponsors and contacts
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Source ClinicalTrials.gov