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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 below
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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 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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 more

Breast53 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

Her2/neu positive and lymph node positive Clinical Trial Eligibility Overview. Trial Name: NCT05288777 — Phase 2 & 3
Breast Cancer Research Study Groups: Her2/neu positive and lymph node positive, Her2/neu positive and lymph node negative, Her2/neu negative and lymph node positive, Her2/neu negative and lymph node negative
Breast Cancer Clinical Trial 2023: Her2/neu positive and lymph node positive Highlights & Side Effects. Trial Name: NCT05288777 — Phase 2 & 3
Her2/neu positive and lymph node positive 2023 Treatment Timeline for Medical Study. Trial Name: NCT05288777 — Phase 2 & 3

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."

Answered by AI
~13 spots leftby Dec 2024