Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer

Part of paid clinical trials in Charlottesville, Virginia.

Sponsor
University of Virginia
Study ID
NCT05288777
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

  • Breast Cancer
  • Breast Cancer Stage I
  • Breast Cancer Stage II
  • Breast Cancer Stage III

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • T-DM1 — DRUG
    Dosed at 3.6 mg/kg of body weight every 3 weeks for Her2/neu+ patients for a total duration of 14 cycles.
  • Capecitabine — DRUG
    Dosed at 825 mg/m2 +/- 150mg twice per day for a total duration of 6 months
  • External Beam Radiation Therapy 0 — RADIATION
    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.
  • External Beam Radiation Therapy 1 — RADIATION
    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.

Study Details

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.

Key Dates

Start date
Jul 11, 2022
Status verified
Apr 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
45 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Her2/neu positive and lymph node positive
    T-DM1/ trastuzumab emtansine infusion along with radiation to the breast or chest wall and lymph nodes
  • Other: Her2/neu positive and lymph node negative
    T-DM1/trastuzumab emtansine infusion along with radiation to the whole breast or chest wall
  • Other: Her2/neu negative and lymph node positive
    oral capecitabine twice per day along with radiation to the breast or chest wall and lymph nodes
  • Other: Her2/neu negative and lymph node negative
    oral capecitabine twice per day along with radiation to the whole breast or chest wall

Primary Outcome Measure

Assess safety via toxicity grading [ Time Frame: 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of VirginiaCharlottesvilleVirginia22903
Song Wood
[email protected]
434 243 0008
Einsley Janowski, Md, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Charlottesville, VA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Virginia· Charlottesville, VA

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