Correlation of Clinical Response to Pathologic Response in Patients With Early Breast Cancer
Sponsored by Baylor Breast Care Center
About this study
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.
Neoadjuvant therapy was first introduced to improve surgical outcomes of breast cancer and to be able to assess the pathological responsiveness to therapy at the time of surgery. Over time, it became a useful experimental platform in clinical research in breast cancer, and in recent years became an important part of standard management of certain subtypes and clinical stages in breast cancer. It has been long established that patients who achieve pathologic complete response (pCR, i.e., the absence of any cancer in the tissue removed during surgery) after receiving neoadjuvant treatment have better outcomes than those who don't, especially in HER2+, and triple-negative breast cancer (TNBC). Many reports add aggressive ER+ breast cancer to these groups. So far, the only way to know whether…
Where this study is enrolling (2)
- I'm interested
Harris Health System - Smith Clinic
Houston, Texas
- I'm interested
O'Quinn Medical Tower - McNair Campus - Dan L Duncan Comprehensive Cancer Center
Houston, Texas
Who can participate
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.
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Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.
Trial data sourced from ClinicalTrials.gov.