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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 : November 28, 2018
Sponsor:
Collaborator:
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
Estrogen Receptor Negative HER2/Neu Negative Invasive Breast Carcinoma Progesterone Receptor Negative 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

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 360 participants
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, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment (predictive results given)
Patients undergo baseline molecular and IHC evaluation. 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 within 12 weeks. Patients may then choose to continue with standard taxane +/- platinum-based chemotherapy or participate in an experimental clinical trial. 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
  • The clinical or radiologic primary tumor size is at least 1.5 cm diameter
  • 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 began and was evaluated for genomic testing (integral biomarker)
  • Patients must have left ventricular ejection fraction (LVEF) > 50% by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) within 4 weeks prior to registration
  • 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 within normal institutional limits 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 randomization
  • 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
Contact: Stacy Moulder 713-792-2817 smoulder@mdanderson.org

Locations
United States, Texas
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 Regional Care Center-Katy Recruiting
Houston, Texas, United States, 77094
Contact: Rachel L. Theriault       rltheriault1@mdanderson.org   
Sub-Investigator: Rachel L. Theriault         
MD Anderson Regional Care Center-Bay Area Recruiting
Nassau Bay, Texas, United States, 77058
Contact: Sausan Z. Abouharb    713-563-0670    sabouharb@mdanderson.org   
Sub-Investigator: Sausan Z. Abouharb         
MD Anderson Regional Care Center-Sugar Land Recruiting
Sugar Land, Texas, United States, 77478
Contact: Sadia Saleem       ssaleem@mdanderson.org   
Sub-Investigator: Sadia Saleem         
MD Anderson Regional Care Center-The Woodlands Recruiting
The Woodlands, Texas, United States, 77384
Contact: Stacy L. Moulder    713-792-2817      
Principal Investigator: Stacy L. Moulder         
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Stacy Moulder M.D. Anderson Cancer Center

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT02276443     History of Changes
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 )
P30CA016672 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2014    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Carcinoma
Breast Neoplasms
Triple Negative Breast Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases