RECRUITING

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

Conditions

Breast Cancer Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage III Radiation Chemoradiation Chemotherapy Chemo T-DM1 xeloda capecitabine Adjuvant Combination treatment trastuzumab

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-07-11

Study Completion:2026-10

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05288777

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Song Wood

CONTACT

4342430008

stw2g@hscmail.mcc.virginia.edu

Principal Investigator

Einsley Janowski, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Virginia

Study Locations (Sites)

University of Virginia

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: University of Virginia

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-11

Study Completion Date2026-10

Study Record Updates

Study Start Date2022-07-11

Study Completion Date2026-10

Terms related to this study

Keywords Provided by Researchers

Radiation
Chemoradiation
Chemotherapy
Chemo
T-DM1
xeloda
capecitabine
Adjuvant
Combination treatment
trastuzumab

Additional Relevant MeSH Terms

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