Combining chemotherapy and radiation for high-risk breast cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and effectiveness of adjuvant chemoradiation therapy in high-risk breast cancer patients who have residual disease after neoadjuvant chemotherapy and surgery. Participants will receive either capecitabine or T-DM1 along with radiation therapy, with the aim of improving local and distant recurrence outcomes. The study also investigates the impact of this treatment on the immune system. Blood samples will be collected at various timepoints to assess immune responses during treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Provision of signed and dated informed consent form
2. Stated willingness to comply with all study procedures and availability for the duration of the study
3. Male or female, aged 18 or older
4. Diagnosis of stage I-IIIB breast cancer
5. Received neoadjuvant chemotherapy (minimum of 3 cycles) and surgical resection (lumpectomy and/or mastectomy)
6. Discovered to have residual disease at least ypT1aNx or ypTxN1mic at surgical resection
7. Candidate for adjuvant chemoradiation as part of standard clinical care
8. Planned initiation of radiation within 12 weeks of their final oncologic surgery
9. ECOG performance status ≤2
10. Adequate cardiac function, with LVEF greater or equal to 45% (only for patients who will receive TDM-1 therapy)
11. 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
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.

Exclusion Criteria:

1. Had a mastectomy with expander placement or immediate reconstructions
2. Diagnosed with systemic lupus
3. Diagnosed with scleroderma
4. 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.
5. Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration.
6. Pathologic evidence of metastatic disease, or strong clinical/radiological evidence of metastatic disease, at the investigator's judgment.
7. Pregnancy or lactation
8. Incarceration
9. Presence of cardiac pacemaker on side of the body that is being treated unless the pacemaker can be moved prior to treatment.
10. Anthracycline exposure exceeding a cumulative doxorubicin dose of 264 mg/m2 (240 mg/m2 plus a 10% threshold)
11. Known allergic reactions to components of capecitabine or T-DM1
12. Known DPD deficiency for patients prescribed capecitabine
13. Febrile illness within a week of starting treatment
14. Incomplete healing of chest wall or breast in the treatment field within 12 weeks from surgery.
15. Known HIV or active hepatitis.
16. Unwilling to discontinue endocrine therapy if currently taking endocrine therapy.

Where it's running

• University of Virginia
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: Einsley Janowski, MD, PhD — University of Virginia
• Study coordinator: Song Wood
• Email: stw2g@hscmail.mcc.virginia.edu
• Phone: 4342430008

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Memantine plus structured exercise to protect thinking and memory during breast cancer chemotherapy

  This will test whether memantine combined with a supervised exercise program, memantine alone, or a placebo can prevent or reduce thinking and memory problems in people receiving chemotherapy for stage I–III breast cancer.

  Recruiting Phase 2 UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina · NCT06727773

• Using tart cherry juice to prevent nerve damage from chemotherapy in breast cancer patients

  This study is testing if drinking tart cherry juice can help prevent nerve damage in breast cancer patients receiving chemotherapy.

  Recruiting Phase 2 University of California, Davis · Sacramento, California · NCT06268665

• Evaluating skin reactions in breast cancer patients receiving proton therapy

  This study is testing a new technique to see if it can help reduce skin reactions in breast cancer patients getting proton therapy.

  Recruiting Covenant Health Cancer Center · Knoxville, Tennessee · NCT06006806

• Capecitabine for MRD-positive, resected ER+/HER2-negative breast cancer

  This Phase 2 trial tests whether taking capecitabine can help people with resected, ER-positive/HER2-negative breast cancer who still have molecular residual disease after standard therapy.

  Recruiting Phase 2 University Health Network, Toronto · Toronto, Ontario · NCT07631052

• SBRT with intratumoural pembrolizumab before neoadjuvant chemotherapy for high-risk breast cancer

  This study will test whether a short course of focused radiation plus two injections of pembrolizumab into the tumor before chemotherapy helps people with high‑risk invasive breast cancer respond better to treatment.

  Recruiting Phase 2 London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's · London, Ontario and 1 other locations · NCT07188246

• Predicting how hormone therapy before surgery affects breast cancer

  This study is testing how hormone therapy before surgery can help people with early-stage breast cancer and what it means for their tumors.

  Recruiting Phase 2 George Washington University · Washington D.C., District of Columbia · NCT06806930

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.