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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02276443
Recruitment Status : Recruiting
First Posted : October 28, 2014
Last Update Posted : January 15, 2021
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
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 Drug: Chemotherapy Other: Laboratory Biomarker Analysis Procedure: Lymph Node Biopsy Procedure: Ultrasonography Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: ARTEMIS: A Robust TNBC Evaluation Framework to Improve Survival
Actual Study Start Date : November 9, 2015
Estimated Primary Completion Date : November 30, 2021
Estimated Study Completion Date : November 30, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Treatment (predictive results given)
Patients undergo baseline molecular and IHC evaluation of their tumor biopsy, and receive the results. Patients then receive standard anthracycline-based chemotherapy and undergo standard ultrasound at baseline, after 2 courses, and after 4 courses of treatment. Patients and physicians are notified of the results of the molecular evaluation. Patients may then choose to continue with standard taxane +/- platinum-based chemotherapy or participate in an experimental clinical trial designed to match the molecular profile and triple-negative subtype. Patients with tumors predicted to be insensitive to chemotherapy are advised to participate in a clinical trial treating their tumor subtype.
Drug: Chemotherapy
Undergo standard chemotherapy
Other Names:
  • Chemo
  • Chemotherapy (NOS)
  • Chemotherapy, Cancer, General

Other: Laboratory Biomarker Analysis
Correlative studies

Procedure: Lymph Node Biopsy
Undergo baseline lymph node evaluation
Other Name: Biopsy of Lymph Node

Procedure: Ultrasonography
Undergo standard ultrasound
Other Names:
  • 2-Dimensional Grayscale Ultrasound Imaging
  • 2-Dimensional Ultrasound Imaging
  • 2D-US
  • Ultrasound
  • Ultrasound Imaging
  • Ultrasound Test
  • Ultrasound, Medical
  • US

Primary Outcome Measures :
  1. Response rate [ Time Frame: Up to 5 years ]
    A one-sided z-test will be used to compare the response rates of the treatment and control arms. The study will have 80% power to detect an increase in the response rate of 14.2 percentage points assuming a control arm response rate of 50% at the 0.05 significance level allowing for two interim tests for both futility and superiority.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 chemotherapy with anthracycline/taxane based regimes
  • 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)
  • Primary tumor sample was collected before NACT begins
  • 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 within normal institutional limits
  • 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 1.5X the upper limits of normal OR creatinine clearance > 60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

Exclusion Criteria:

  • The patient has diagnosis of stage IV disease or is found to have stage IV disease prior to start of NACT
  • 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 anthracyclines
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02276443

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Contact: Stacy Moulder 713-792-2817

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United States, Texas
MD Anderson in The Woodlands Recruiting
Conroe, Texas, United States, 77384
Contact: Stacy L. Moulder    713-792-2817      
Principal Investigator: Stacy L. Moulder         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Stacy L. Moulder    713-792-2817   
Principal Investigator: Stacy L. Moulder         
MD Anderson West Houston Recruiting
Houston, Texas, United States, 77079
Contact: Rachel L. Theriault   
Sub-Investigator: Rachel L. Theriault         
MD Anderson League City Recruiting
League City, Texas, United States, 77573
Contact: Sausan Z. Abouharb    713-563-0670   
Sub-Investigator: Sausan Z. Abouharb         
MD Anderson in Sugar Land Recruiting
Sugar Land, Texas, United States, 77478
Contact: Sadia Saleem   
Sub-Investigator: Sadia Saleem         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
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Principal Investigator: Stacy L Moulder M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT02276443    
Other Study ID Numbers: 2014-0185
NCI-2015-00191 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2014-0185 ( Other Identifier: M D Anderson Cancer Center )
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: January 15, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site
Breast Diseases
Skin Diseases