Improving treatment response in triple-negative breast cancer patients using molecular testing and imaging

ARTEMIS: A Robust TNBC Evaluation FraMework to Improve Survival

This study is testing a new way to use tumor testing and imaging to see if it can help people with triple-negative breast cancer get better treatment options that work best for them.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 5 sites (Conroe, Texas and 4 other locations)
• Trial ID: NCT02276443 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates a new algorithm that analyzes the genomic signature of tumors in patients with newly diagnosed triple-negative breast cancer (TNBC) to predict their response to standard chemotherapy versus personalized treatment options. The study involves a prospective, single-arm, non-randomized approach, utilizing diagnostic imaging to assess responses to neoadjuvant chemotherapy and to subtype TNBC for tailored therapy. Key objectives include measuring various survival rates and evaluating the frequency of pathologic responses based on tumor classification. The trial aims to enhance treatment efficacy by identifying patients with chemotherapy-insensitive disease and directing them to appropriate clinical trials.

Who should consider this trial

Good fit: Ideal candidates are patients with clinical stage I to III triple-negative breast cancer who are eligible for neoadjuvant chemotherapy.

Not a fit: Patients with non-invasive breast cancer or those who do not meet the eligibility criteria for neoadjuvant therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective treatment strategies for patients with triple-negative breast cancer, improving their chances of survival.

How similar studies have performed: Other studies have shown promise in using molecular characterization to guide treatment in breast cancer, suggesting potential for success in this approach.

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

Where this trial is running

Conroe, Texas and 4 other locations

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

Study contacts

• Principal investigator: Clinton Yam — M.D. Anderson Cancer Center

Conditions: 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