Molecular Testing and Imaging in Improving Response in Patients With Stage I-III Triple-Negative Breast Cancer Receiving Chemotherapy MDACC Breast Moonshot Initiative

Korábbi kezelés

• The patient has diagnosis of stage IV disease or is found to have stage IV disease prior to initiation of chemotherapy
• Prior excisional biopsy of the primary invasive breast cancer
• Patients not eligible for chemotherapy with taxane and/or anthracycline based chemotherapy regimens
• Prior therapy with - chemotherapy and/or immunotherapy

Más betegség

• Prior history of invasive cancer within 5 years of study entry or history of metastatic cancer; exceptions include non-metastatic, curatively treated basal and squamous cell carcinoma of the skin
• Patients with history of serious cardiac events defined as:
  • Patients with a history of New York Heart Association class 3 or 4 heart failure, or history of myocardial infarction, unstable angina or cerebrovascular accident (CVA) within 6 months of protocol registration
  • Patients who have history of PR prolongation (grade 2 or higher) or atrioventricular (AV) block

Egyéb

• Patients with hematomas or biopsy site changes that limit response assessment of the primary tumor by diagnostic imaging
• Grade II or higher neuropathy
• Patients with Zubrod performance status of > 2

• The patient can undergo biopsy or surgery of a primary tumor site for suspected or proven invasive breast cancer of clinical stage I to III and are planned to receive neoadjuvant therapy with anthracycline/taxane based regimens (Arm A and Arm B) or chemotherapy/immunotherapy-based regimens (Arm C)
• The patient was proven to have TNBC, defined from standard pathologic assays as negative for ER and PR (< 10% tumor staining) and negative for HER2 (immunohistochemistry [IHC] score < 3, gene copy number not amplified)
• Patients must have left ventricular ejection fraction (LVEF) >= 50% by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) within 12 weeks prior to starting adriamycin
• Leukocytes > 3,000/mcL
• Absolute neutrophil count > 1,500/mcL
• Platelets > 100,000/mcL
• Total bilirubin =< 1.5 x upper limit of normal (ULN)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) < 2.5 x institutional upper limit of normal
• Creatinine within 1.5 X the upper limits of normal OR creatinine clearance > 60 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal
• For Arms A and B, patients must be medically ineligible to receive immunotherapy in combination with anthracycline/taxane-based chemotherapy as part of standard care
• For Arm C, patients must be medically eligible to receive immunotherapy in combination with chemotherapy as part of standard of care