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

Running, not enrolling · Not applicable

Conditions studied: Invasive Breast Carcinoma, Stage I Breast Cancer AJCC v7, Stage IA Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage IIB Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage IIIA Breast Cancer AJCC v7, Stage IIIB Breast Cancer AJCC v7, Stage IIIC Breast Cancer AJCC v7, Triple-Negative Breast Carcinoma

In brief

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.

Key facts

Study ID

NCT02276443

Run by

M.D. Anderson Cancer Center

People needed

798

Starts

2015-11-09

Expected to finish

2026-11-30

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 - chemotherapy and/or immunotherapy
• 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

Where it is running

• MD Anderson in The Woodlands — Conroe, Texas, United States
• M D Anderson Cancer Center — Houston, Texas, United States
• MD Anderson West Houston — Houston, Texas, United States
• MD Anderson League City — League City, Texas, United States
• MD Anderson in Sugar Land — Sugar Land, Texas, United States

Full record on ClinicalTrials.gov

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