Combining chemotherapy and radiation for high-risk breast cancer patients
A Study of Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
This study tests whether combining chemotherapy and radiation can help high-risk breast cancer patients who still have cancer after initial treatment, while also looking at how this treatment affects their immune system.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 45 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Drugs / interventions | chemotherapy, radiation, doxorubicin, Trastuzumab |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT05288777 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 or older with stage I-IIIB breast cancer who have undergone neoadjuvant chemotherapy and have residual disease post-surgery.
Not a fit: Patients with early-stage breast cancer who do not have residual disease after surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the risk of recurrence and improve survival rates for high-risk breast cancer patients.
How similar studies have performed: While chemoradiation is a standard treatment for many cancers, its application as adjuvant therapy in breast cancer is less common, making this approach relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Charlottesville, Virginia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.