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Adjuvant Chemoradiation and Biomarkers for High-Risk Breast Cancer

This study is looking at how safe and effective a combination of treatments is for people with high-risk breast cancer. You might be able to join if you are 18 or older, have Stage I-IIIB breast cancer, and have already had chemotherapy before surgery (neoadjuvant chemotherapy) and then surgery (lumpectomy or mastectomy). The treatments being studied are T-DM1 (a drug for HER2-positive cancer), Capecitabine (another drug), and External Beam Radiation Therapy. Researchers want to see if these treatments cause side effects and if people can complete the full treatment plan. They are also looking at how these treatments affect the immune system. The study aims to enroll 45 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. It plans to enroll 45 participants, but the phase and current status are not specified.
What's involved
Participants would receive T-DM1 for about 14 cycles, Capecitabine for 6 months, and External Beam Radiation Therapy for 15-19 days. The study will assess safety and feasibility for one year.
Compensation
Not stated in the trial record.
Follow-up
The study will assess safety and feasibility for one year after treatment begins.

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NCT05288777

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Virginia
~45 participants
Updated 2025-04-18 on ClinicalTrials.gov
What's tested:T-DM1CapecitabineExternal Beam Radiation Therapy 0External Beam Radiation Therapy 1

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assess safety via toxicity grading
Measured over 1 year
+1 more outcome measured

Conditions

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

Explore related trials

Breast Carcinoma

Where it's being run

1 sites across 1 states
Virginia1

Study leadership

  • Einsley Janowski, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Virginia

Who to contact

Song Wood
[email protected]
4342430008
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

What this trial measures

  • Assess safety via toxicity grading1 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 completion1 year

    Percent of participants completing adjuvant chemoradiation therapy and percent of participants requiring radiation or chemotherapy dose delays.