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

Launched by M.D. ANDERSON CANCER CENTER · Oct 24, 2014

Keywords

ClinConnect Summary

This clinical trial is investigating a new approach to treating patients with early-stage triple-negative breast cancer (TNBC) by using a special algorithm that analyzes the genetic information of each patient’s tumor. The goal is to see if this personalized information can help doctors choose the most effective treatment for each individual, potentially improving how well the cancer responds to chemotherapy. Participants will have their tumor biopsies tested for specific proteins and immune cell activity, which may help determine the best treatment options for them.

To be eligible for this trial, participants should be adults with stage I to III invasive breast cancer who have been diagnosed with TNBC. They need to be able to undergo a biopsy or surgery and plan to receive specific chemotherapy treatments. Participants will also need to meet certain health criteria, such as having a healthy heart function and certain blood counts. While in the trial, participants can expect to receive either standard chemotherapy or a personalized treatment plan based on their tumor's characteristics, and they will be closely monitored throughout the process. This study is currently recruiting participants, so there is an opportunity for eligible patients to contribute to important research that could improve future treatment for TNBC.

Gender

ALL

Eligibility 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 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
• 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 - 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