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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
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

Full criteria on ClinicalTrials.gov

Sites (5)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
MD Anderson in The Woodlands
Coordinator of this site? Confirm its status
ConroeUnited StatesUnknown status
M D Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
MD Anderson West Houston
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
MD Anderson League City
Coordinator of this site? Confirm its status
League CityUnited StatesUnknown status
MD Anderson in Sugar Land
Coordinator of this site? Confirm its status
Sugar LandUnited StatesUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.