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

• Status: Recruiting
• Trial end date: 2023-11-30
• Target enrollment: 0
• Participant gender: All

Summary

This clinical trial assesses whether a newly designed algorithm which looks at the genomic signature of each patient's tumor to predict their sensitivity to standard of care treatment verses being placed on a personally designed treatment trial can improve the responses in patients with newly diagnosed triple-negative breast cancer (TNBC). Testing the primary tumor biopsy for certain proteins and monitoring the lymphocyte infiltration into the tumors may help doctors determine the sub-type of TNBC, and direct treatments that may work well. It is not yet known whether assigning treatment based on the patient's tumor classification will improve how well the tumor responds.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center

Criteria

Inclusion Criteria:

• 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 chemotherapy with anthracycline/taxane based regimens

• 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

Exclusion Criteria:

• The patient has diagnosis of stage IV disease or is found to have stage IV disease prior to initiation of chemotherapy

• 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

• Prior excisional biopsy of the primary invasive breast cancer

• Patients with hematomas or biopsy site changes that limit response assessment of the primary tumor by diagnostic imaging

• Patients not eligible for chemotherapy with taxane and/or anthracycline based chemotherapy regimens

• Prior therapy with anthracyclines

• Grade II or higher neuropathy

• Patients with Zubrod performance status of > 2

• 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