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Chemoradiation for High-risk Breast Cancer (Breast53 Trial)
Phase 2 & 3
Recruiting
Led By Einsley Janowski, MD, PhD
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Received neoadjuvant chemotherapy (minimum of 3 cycles) and surgical resection (lumpectomy and/or mastectomy)
Male or female, aged 18 or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Breast53 Trial Summary
This trial is testing a new breast cancer treatment that combines chemotherapy and radiation. They want to see if it's safe and effective, especially in patients who are high risk.
Who is the study for?
This trial is for adults over 18 with stage I-IIIB breast cancer who've had neoadjuvant chemotherapy and surgery but still have residual disease. They must be able to follow the study plan, start radiation within 12 weeks post-surgery, and have good organ function. Those pregnant, lactating, or with certain medical conditions like severe allergies to treatment components or infections are excluded.Check my eligibility
What is being tested?
The study tests adjuvant chemoradiation's safety and effectiveness in high-risk breast cancer patients after surgery. It involves T-DM1 (a targeted therapy), Capecitabine (chemotherapy), and External Beam Radiation Therapy to see how they work together against remaining cancer cells.See study design
What are the potential side effects?
Possible side effects include reactions related to the immune system from T-DM1, skin irritation from radiation therapy, hand-foot syndrome from Capecitabine, fatigue common with cancer treatments, as well as potential heart issues especially for those on T-DM1.
Breast53 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I've had at least 3 rounds of chemo and surgery for my breast cancer.
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I am 18 years old or older.
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I can take care of myself but might not be able to do heavy physical work.
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I am eligible for additional therapy after my main cancer treatment.
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I will start radiation within 12 weeks after my last cancer surgery.
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My organs are functioning well enough for treatment.
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I am on warfarin and will have my blood thinner management checked before starting capecitabine.
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My breast cancer is at stage I to IIIB.
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My surgery showed I still have some cancer left.
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My heart is strong enough for TDM-1 therapy (LVEF ≥ 45%).
Breast53 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Assess feasibility via treatment delays and completion
Assess safety via toxicity grading
Secondary outcome measures
Assess acute cosmetic outcomes via RTOG/EORTC scale
Assess chronic cosmetic outcomes via LENT-SOMA scale
Assess cosmetic outcomes via breast measurements
Other outcome measures
Assess quality of life via FACT-B patient survey
Assess quality of life via RAND SF-36 patient survey
Describe the amount and type of immune cells via lab tests
+1 moreBreast53 Trial Design
4Treatment groups
Experimental Treatment
Group I: Her2/neu positive and lymph node positiveExperimental Treatment2 Interventions
T-DM1/ trastuzumab emtansine infusion along with radiation to the breast or chest wall and lymph nodes
Group II: Her2/neu positive and lymph node negativeExperimental Treatment2 Interventions
T-DM1/trastuzumab emtansine infusion along with radiation to the whole breast or chest wall
Group III: Her2/neu negative and lymph node positiveExperimental Treatment2 Interventions
oral capecitabine twice per day along with radiation to the breast or chest wall and lymph nodes
Group IV: Her2/neu negative and lymph node negativeExperimental Treatment2 Interventions
oral capecitabine twice per day along with radiation to the whole breast or chest wall
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Trastuzumab emtansine
FDA approved
Capecitabine
FDA approved
Find a Location
Who is running the clinical trial?
University of VirginiaLead Sponsor
753 Previous Clinical Trials
1,244,995 Total Patients Enrolled
9 Trials studying Breast Cancer
1,997 Patients Enrolled for Breast Cancer
Einsley Janowski, MD, PhDPrincipal InvestigatorUniversity of Virginia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I've had at least 3 rounds of chemo and surgery for my breast cancer.I am 18 years old or older.I can take care of myself but might not be able to do heavy physical work.I am currently on IV antibiotics for a bacterial or fungal infection.I have a pacemaker on the side of my body that needs treatment.You are allergic to the ingredients in capecitabine or T-DM1.I am eligible for additional therapy after my main cancer treatment.I will start radiation within 12 weeks after my last cancer surgery.My organs are functioning well enough for treatment.You have been diagnosed with cancer that has spread to other parts of your body.I am on warfarin and will have my blood thinner management checked before starting capecitabine.I have been diagnosed with scleroderma.I have HIV or active hepatitis.I do not have a DPD deficiency.I have a genetic condition that makes me more sensitive to radiation.I have received more than the maximum safe dose of a specific chemotherapy drug.You are currently in prison.My breast cancer is at stage I to IIIB.I have not had a fever or flu-like illness in the past week.My surgery showed I still have some cancer left.My chest or breast surgery wound hasn't fully healed in 12 weeks.I have been diagnosed with systemic lupus.I had a mastectomy with either an expander or immediate reconstruction.I am not willing to stop my hormone therapy.My heart is strong enough for TDM-1 therapy (LVEF ≥ 45%).
Research Study Groups:
This trial has the following groups:- Group 1: Her2/neu positive and lymph node positive
- Group 2: Her2/neu positive and lymph node negative
- Group 3: Her2/neu negative and lymph node positive
- Group 4: Her2/neu negative and lymph node negative
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any unfilled positions in this clinical trial for new patients?
"According to the listing on clinicaltrials.gov, this research is not presently recruiting participants. The trial was initially posted on May 1st, 2022 and last updated a month ago on April 12th, 2022. There are 2695 other trials that currently seeking patients."
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