Actively Recruiting
Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
Led by Baylor Breast Care Center · Updated on 2025-02-27
185
Participants Needed
2
Research Sites
341 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to learn whether clinical response (the amount a tumor shrinks based on imaging or tumor measurements obtained by physical exam) predicts pathologic response (the amount of tumor remaining when surgery is performed) in participants with breast cancer who are receiving chemotherapy prior to surgery.
CONDITIONS
Official Title
Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- At least 18 years of age and legally able to provide informed consent
- Both men and women are eligible
- Histologically confirmed invasive breast cancer: triple negative, HER2-positive, or high-risk estrogen receptor positive
- For high-risk estrogen receptor positive, must meet at least 2 of: histologic grade 3, age 50 or less, ER Allred score below 6, or Ki-67 30% or higher
- Tumor size at least 2 cm by clinical exam or ultrasound
- Bilateral breast cancers allowed if one side is designated as the index lesion and the same treatment is appropriate for both
- ECOG performance status of 0 or 1
- Left ventricular ejection fraction at or above institutional lower limit of normal as assessed by echocardiogram or MUGA scan
- Adequate organ function including ANC 1200/mm3 or higher, platelets 100,000/mm3 or higher, hemoglobin 9 g/dL or higher, bilirubin within normal limits unless Gilbert's syndrome, ALP 2.5 times or less upper limit of normal, AST/ALT 1.5 times or less upper limit of normal, and serum creatinine within normal limits
- Willingness to use effective non-hormonal contraception if of childbearing potential
- Participation in a concurrent clinical trial allowed with Principal Investigator approval
You will not qualify if you...
- Definitive clinical or radiologic evidence of Stage IV breast cancer
- Inflammatory breast cancer
- Pregnant or lactating participants
- History of excisional biopsy or lumpectomy prior to study entry
- Prior treatment with anthracyclines for any malignancy
- Prior treatment for current breast cancer including endocrine therapy, chemotherapy, targeted therapy, or radiation
- History of cardiac disease that would prevent use of study treatments, including angina requiring medication, significant arrhythmias, pacemaker dependence, valvular disease, symptomatic pericarditis, cardiomyopathy, congestive heart failure, or myocardial infarction
- Current infection with HIV, hepatitis B, or hepatitis C
- History of non-breast malignancies within 5 years except certain in situ or skin cancers
- Any other systemic disease preventing treatment or required follow-up
- Psychiatric, addictive, social, or other medical conditions that would prevent meeting study requirements
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Harris Health System - Smith Clinic
Houston, Texas, United States, 77054
Actively Recruiting
2
O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77054
Actively Recruiting
Research Team
M
Maria Rodriguez
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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