Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:17 AM
Ignite Modification Date:
2025-12-25 @ 2:17 AM
NCT ID:
NCT05020860
Eligibility Criteria:
Inclusion Criteria:
* At least 18 years of age, and legally able to provide informed consent. Both men and women are eligible.
* Histologically confirmed, invasive breast cancer. Tumor may be triple negative (as defined by ASCO-CAP guidelines), HER2-positive (as defined by ASCO-CAP guidelines), or high-risk estrogen receptor positive (as defined by ASCO-CAP guidelines).
To be considered "high risk," at least 2 of the following criteria must be met: 1) histologic grade 3; 2) patient age 50 or less; 3) ER Allred score \< 6; 4) Ki-67 ≥ 30%.
* Tumors must be at least 2 cm by clinical exam or ultrasound
* Bilateral breast cancers are allowed if the following criteria are met: 1) A lesion on one side (meeting the criteria above) is designated as the index lesion on which study assessments will be performed, and 2) the same treatment regimen is appropriate for both cancers as determined by the treating physician.
* ECOG performance status of 0 or 1
* Left ventricular ejection fraction (LVEF) ≥ the institutional lower limit of normal, as assessed by echocardiogram or Multigated Acquisition (MUGA )scan.
* Adequate organ function, as determined by the following parameters:
* Absolute Neutrophil Count (ANC) ≥ 1200/mm3
* Platelets ≥ 100,000/mm3
* Hemoglobin ≥ 9 g/dL
* Total bilirubin ≤ institutional upper limit of normal (ULN), unless patient has Gilbert's disease or similar syndrome
* Alkaline phosphatase (ALP) ≤ 2.5 x institutional ULN
* Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 1.5 x institutional ULN
* Serum creatinine ≤ institutional ULN
* The participant, if of childbearing potential, is willing to use effective, non-hormonal contraception while on treatment.
* Participation in a concurrent clinical trial is permitted, with Principal Investigator approval.
Exclusion Criteria:
* Definitive clinical or radiologic evidence of Stage IV disease
* Inflammatory breast cancer
* Participants who are pregnant or lactating
* History of an excisional biopsy or lumpectomy performed prior to study entry
* Prior treatment with anthracyclines for any malignancy.
* Prior treatment for currently diagnosed breast cancer (i.e., endocrine therapy, chemotherapy, targeted therapy, or radiation.
* History of cardiac disease that would preclude the use of drugs included in these treatment regimens. This includes, but is not limited to:
* Angina pectoris requiring the use of anti-anginal medication
* Ventricular arrhythmias except for benign premature ventricular contractions
* Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication
* Conduction abnormality requiring a pacemaker
* Valvular disease with documented compromise in cardiac function
* Symptomatic pericarditis
* Documented cardiomyopathy
* History of documented congestive heart failure (CHF)
* Myocardial infarction documented by elevated cardiac enzymes, or persistent regional wall abnormalities on assessment of left ventricular function.
* Current HIV, hepatitis B, or hepatitis C infection
* History of non-breast malignancies (with the exception of in situ cancers treated only by local excision, and basal cell or squamous cell carcinoma of the skin) within 5 years prior to enrollment.
* Any other non-malignant systemic disease that would preclude treatment with any of the treatment regimens or prevent required follow-up.
* Any psychiatric or addictive disorders, adverse social situations, or other medical conditions that, in the opinion of the investigator, would preclude the patient from meeting study requirements.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05020860
Study Brief:
Protocol Section:
NCT05020860