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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

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ClinicalTrials.gov Identifier: NCT02276443
Recruitment Status : Recruiting
First Posted : October 28, 2014
Last Update Posted : April 28, 2021
Sponsor:
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, 2023

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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 chemotherapy with anthracycline/taxane based regimens
  • 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

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 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 ClinicalTrials.gov identifier (NCT number): NCT02276443


Contacts
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Contact: Elizabeth Ravenberg 713-563-9033 EEvans1@mdanderson.org
Contact: Alyson Clayborn 713-745-8748 ARClayborn@mdanderson.org

Locations
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United States, Texas
MD Anderson in The Woodlands Recruiting
Conroe, Texas, United States, 77384
Contact: Yam         
Principal Investigator: Clinton Yam         
M D Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Clinton Yam         
Principal Investigator: Clinton Yam         
MD Anderson West Houston Recruiting
Houston, Texas, United States, 77079
Sub-Investigator: Ajit Bisen         
MD Anderson League City Recruiting
League City, Texas, United States, 77573
Sub-Investigator: Sausan Z. Abouharb         
MD Anderson in Sugar Land Recruiting
Sugar Land, Texas, United States, 77478
Sub-Investigator: Sadia Saleem         
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
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Principal Investigator: Clinton Yam M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov 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: April 28, 2021
Last Verified: April 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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Carcinoma
Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases