Breast Cancer Clinical Trial
Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
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 patients with breast cancer who are receiving chemotherapy prior to surgery.
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 less than 50; 3) ER Allred score < 6; 4) Ki-67 ≥ 30%.
Tumors must be at least 2 cm by clinical exam or ultrasound
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.
Definitive clinical or radiologic evidence of Stage IV disease
Bilateral invasive breast cancer
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
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.
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There are 2 Locations for this study
Houston Texas, 77030, United States More Info
Houston Texas, 77054, United States More Info
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