NCT02276443Active, not recruiting
Molecular Testing and Imaging in Improving Response in Patients With Stage I-III Triple-Negative Breast Cancer Receiving Chemotherapy MDACC Breast Moonshot Initiative
ARTEMIS: A Robust TNBC Evaluation FraMework to Improve Survival
Source: ClinicalTrials.gov · Last updated 15 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 798 (actual)
- First submitted
- 21 Oct 2014
- Start date
- 9 Nov 2015
- Primary completion date
- 30 Nov 2026
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Triple-negative breast cancer
- NCT number
- NCT02276443
What you commit to
- Study type: Interventional
- Participants enrolled: 798
- From 9 Nov 2015 to the primary completion date, 30 Nov 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| MD Anderson in The Woodlands Coordinator of this site? Confirm its status | Conroe | United States | Unknown status |
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| MD Anderson West Houston Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| MD Anderson League City Coordinator of this site? Confirm its status | League City | United States | Unknown status |
| MD Anderson in Sugar Land Coordinator of this site? Confirm its status | Sugar Land | United States | Unknown status |
Related publications
- The ARTEMIS trial identifies immune activation as a key predictor of neoadjuvant chemotherapy response in triple-negative breast cancer.Breast Cancer Res · 2026 · PMID 42093035
This page is information, not medical advice. Discuss any trial with your doctor.