Breast CancerPhase 2/3Breast53NCT05288777
Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
A Phase 2/3 study testing T-DM1, Capecitabine and External Beam Radiation Therapy 0 in people with Breast Cancer and Breast Cancer Stage I, run by University of Virginia at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Breast Cancer Stage I, Breast Cancer Stage II
- What is being tested?
- T-DM1, Capecitabine and External Beam Radiation Therapy 0
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2022to Dec 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 or older
- Diagnosis of stage I-IIIB breast cancer
- Received neoadjuvant chemotherapy (minimum of 3 cycles) and surgical resection (lumpectomy and/or mastectomy)
- Discovered to have residual disease at least ypT1aNx or ypTxN1mic at surgical resection
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- Candidate for adjuvant chemoradiation as part of standard clinical care
- Planned initiation of radiation within 12 weeks of their final oncologic surgery
- ECOG performance status ≤2
- Adequate cardiac function, with LVEF greater or equal to 45% (only for patients who will receive TDM-1 therapy)
- 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
- 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
- Agreement to adhere to Lifestyle Considerations throughout study duration
- Subjects taking warfarin and plan to receive capecitabine will need their anticoagulant management assessed before starting treatment.
Who cannot join
- Had a mastectomy with expander placement or immediate reconstructions
- Diagnosed with systemic lupus
- Diagnosed with scleroderma
- 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.
- Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration.
- Pathologic evidence of metastatic disease, or strong clinical/radiological evidence of metastatic disease, at the investigator's judgment.
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- Pregnancy or lactation
- Incarceration
- Presence of cardiac pacemaker on side of the body that is being treated unless the pacemaker can be moved prior to treatment.
- Anthracycline exposure exceeding a cumulative doxorubicin dose of 264 mg/m2 (240 mg/m2 plus a 10% threshold)
- Known allergic reactions to components of capecitabine or T-DM1
- Known DPD deficiency for patients prescribed capecitabine
- Febrile illness within a week of starting treatment
- Incomplete healing of chest wall or breast in the treatment field within 12 weeks from surgery.
- Known HIV or active hepatitis.
- Unwilling to discontinue endocrine therapy if currently taking endocrine therapy.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Song Wood, 434 243 0008, stw2g@hscmail.mcc.virginia.edu
Einsley Janowski, Md, PhD
About this study
Official title: A Study of Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
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.
Read the detailed description
Breast cancer is often treated with a combination of surgery, chemotherapy and radiation. In patients with advanced breast cancer, (neoadjuvant) chemotherapy is often given prior to surgical removal (lumpectomy and/or mastectomy). Neoadjuvant chemotherapy has been consistently shown to down-stage primary breast tumors and convert positive underarm lymph nodes to pathologically negative nodes. Residual disease discovered after receiving neoadjuvant chemotherapy indicates an increased risk for recurrence and poor overall survival. The combination of concurrent chemotherapy and radiation after surgery (adjuvant chemoradiation) may improve local and distant recurrence outcomes in high risk breast cancer patients. Chemoradiation is a standard treatment for many cancers and is universally associated with improvements in local recurrence, however, it has not historically been given as post-surgery breast cancer treatment.
The study will evaluate the safety, feasibility, and effectiveness of chemoradiation therapy in high-risk breast cancer patients. Radiation has been associated with various effects on immune cells. The study will also examine the effects of this combination on the immune cells.
Participants on this trial will be treated (per approved clinical guidelines) with capecitabine or Trastuzumab emtansine (T-DM1) depending on Her2 status while receiving radiation at the same time. Participants will have their blood drawn at various timepoints during treatment and follow up. Participants will also be asked to complete surveys asking about overall health and wellbeing.
- Being tested
- T-DM1, Capecitabine, External Beam Radiation Therapy 0, External Beam Radiation Therapy 1
- Keywords
- Radiation, Chemoradiation, Chemotherapy, Chemo, T-DM1, xeloda, capecitabine, Adjuvant, Combination treatment, trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T-DM1Drug
Also called trastuzumab emtansine
Dosed at 3.6 mg/kg of body weight every 3 weeks for Her2/neu+ patients for a total duration of 14 cycles.
CapecitabineDrug
Also called xeloda
Dosed at 825 mg/m2 +/- 150mg twice per day for a total duration of 6 months
External Beam Radiation Therapy 0Radiation
Also called EBRT
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 1Radiation
Also called EBRT
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 group | Role | What they receive |
|---|---|---|
| Her2/neu positive and lymph node positive | Other | T-DM1/ trastuzumab emtansine infusion along with radiation to the breast or chest wall and lymph nodes Receives: Drug: T-DM1; Radiation: External Beam Radiation Therapy 1 |
| Her2/neu positive and lymph node negative | Other | T-DM1/trastuzumab emtansine infusion along with radiation to the whole breast or chest wall Receives: Drug: T-DM1; Radiation: External Beam Radiation Therapy 0 |
| Her2/neu negative and lymph node positive | Other | oral capecitabine twice per day along with radiation to the breast or chest wall and lymph nodes Receives: Drug: Capecitabine; Radiation: External Beam Radiation Therapy 1 |
| Her2/neu negative and lymph node negative | Other | oral capecitabine twice per day along with radiation to the whole breast or chest wall Receives: Drug: Capecitabine; Radiation: External Beam Radiation Therapy 0 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess safety via toxicity grading
Assessment of toxicity frequency and severity using CTCAE v5.0 adverse event grading scale throughout chemoradiation treatment and follow up.
Measured: 1 year
Assess feasibility via treatment delays and completion
Percent of participants completing adjuvant chemoradiation therapy and percent of participants requiring radiation or chemotherapy dose delays.
Measured: 1 year
Secondary outcomes (3)
Assess chronic cosmetic outcomes via LENT-SOMA scale
Assessment of chronic radiation-related cosmetic outcomes (e.g. dermatitis, telangiectasia, pigmentation, and radiation fibrosis) using "Late Effects Normal Tissue Task Force (LENT)-Subjective, Objective, Management, Analytic (SOMA)" scale throughout chemoradiation treatment and follow up. Each side effect is graded on a scale of 0 to 4, with higher scores meaning more severe outcome.
Measured: 1 year
Assess acute cosmetic outcomes via RTOG/EORTC scale
Assessment of overall acute radiation related skin changes using the "Toxicity Criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC)" grading scale throughout chemoradiation treatment and follow up. Each side effect is graded on a scale of 0 to 4, with higher scores meaning more severe outcome.
Measured: 1 year
Assess cosmetic outcomes via breast measurements
Measurement of breast tissue size by measuring tape/ruler.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start11 Jul 2022
- Primary completionDec 2028 (estimated)
- Study completionDec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized assignment based on Her2/neu status and lymph node involvement
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Einsley-Marie Janowski, MD, University of Virginia
- Investigators
- Einsley Janowski, MD, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288777
- Sponsor's protocol ID
- HSR210410
- Acronym
- Breast53
- Status last verified
- Apr 2025
- First submitted
- 24 Feb 2022
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Adjuvant Chemoradiation and Biomarkers of Response in High-risk Breast Cancer
- ClinicalTrials.gov ID
- NCT05288777
- Acronym / sponsor ID
- Breast53 / HSR210410
- Keywords
- Radiation, Chemoradiation, Chemotherapy, Chemo, T-DM1, xeloda, capecitabine, Adjuvant
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 11 Jul 2022 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2029 (estimated)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Breast cancer is often treated with a combination of surgery, chemotherapy and radiation. In patients with advanced breast cancer, (neoadjuvant) chemotherapy is often given prior to surgical removal (lumpectomy and/or mastectomy). Neoadjuvant chemotherapy has been consistently shown to down-stage primary breast tumors and convert positive underarm lymph nodes to pathologically negative nodes. Residual disease discovered after receiving neoadjuvant chemotherapy indicates an increased risk for recurrence and poor overall survival. The combination of concurrent chemotherapy and radiation after surgery (adjuvant chemoradiation) may improve local and distant recurrence outcomes in high risk breast cancer patients. Chemoradiation is a standard treatment for many cancers and is universally associated with improvements in local recurrence, however, it has not historically been given as post-surgery breast cancer treatment.
The study will evaluate the safety, feasibility, and effectiveness of chemoradiation therapy in high-risk breast cancer patients. Radiation has been associated with various effects on immune cells. The study will also examine the effects of this combination on the immune cells.
Participants on this trial will be treated (per approved clinical guidelines) with capecitabine or Trastuzumab emtansine (T-DM1) depending on Her2 status while receiving radiation at the same time. Participants will have their blood drawn at various timepoints during treatment and follow up. Participants will also be asked to complete surveys asking about overall health and wellbeing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- Non-randomized assignment based on Her2/neu status and lymph node involvement
| Arm | Type | Receives |
|---|---|---|
| Her2/neu positive and lymph node positive | Other | Drug: T-DM1, Radiation: External Beam Radiation Therapy 1T-DM1/ trastuzumab emtansine infusion along with radiation to the breast or chest wall and lymph nodes |
| Her2/neu positive and lymph node negative | Other | Drug: T-DM1, Radiation: External Beam Radiation Therapy 0T-DM1/trastuzumab emtansine infusion along with radiation to the whole breast or chest wall |
| Her2/neu negative and lymph node positive | Other | Drug: Capecitabine, Radiation: External Beam Radiation Therapy 1oral capecitabine twice per day along with radiation to the breast or chest wall and lymph nodes |
| Her2/neu negative and lymph node negative | Other | Drug: Capecitabine, Radiation: External Beam Radiation Therapy 0oral capecitabine twice per day along with radiation to the whole breast or chest wall |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Provision of signed and dated informed consent form
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Male or female, aged 18 or older
- Diagnosis of stage I-IIIB breast cancer
- Received neoadjuvant chemotherapy (minimum of 3 cycles) and surgical resection (lumpectomy and/or mastectomy)
Key exclusion criteria (16 listed)
- Had a mastectomy with expander placement or immediate reconstructions
- Diagnosed with systemic lupus
- Diagnosed with scleroderma
- 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.
- Acute bacterial or fungal infection requiring intravenous antibiotics at time of registration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T-DM1Also: trastuzumab emtansineDosed at 3.6 mg/kg of body weight every 3 weeks for Her2/neu+ patients for a total duration of 14 cycles. | Drug | Her2/neu positive and lymph node negative, Her2/neu positive and lymph node positive |
| CapecitabineAlso: xelodaDosed at 825 mg/m2 +/- 150mg twice per day for a total duration of 6 months | Drug | Her2/neu negative and lymph node negative, Her2/neu negative and lymph node positive |
| External Beam Radiation Therapy 0Also: EBRTDose 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. | Radiation | Her2/neu negative and lymph node negative, Her2/neu positive and lymph node negative |
| External Beam Radiation Therapy 1Also: EBRTDose 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. | Radiation | Her2/neu negative and lymph node positive, Her2/neu positive and lymph node positive |
Primary outcome
Assess safety via toxicity grading
Time frame: 1 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 completion
Time frame: 1 year
Percent of participants completing adjuvant chemoradiation therapy and percent of participants requiring radiation or chemotherapy dose delays.
3 secondary outcomes
Assess chronic cosmetic outcomes via LENT-SOMA scale
Time frame: 1 year
Assess acute cosmetic outcomes via RTOG/EORTC scale
Time frame: 1 year
Assess cosmetic outcomes via breast measurements
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Einsley Janowski, MD, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing T-DM1, Capecitabine and External Beam Radiation Therapy 0 in people with Breast Cancer and Breast Cancer Stage I, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Song Wood (4342430008, stw2g@hscmail.mcc.virginia.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess safety via toxicity grading (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2025.