Status:
ACTIVE_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
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Invasive Breast Carcinoma
Stage I Breast Cancer AJCC v7
Eligibility:
All Genders
18+ years
Phase:
NA
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 pla...
Detailed Description
PRIMARY OBJECTIVE: I. To conduct a prospective single arm, non-randomized trial to determine the impact of implementation of a research platform that includes diagnostic imaging to assess response to...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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 - chemotherapy and/or immunotherapy
- 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
Key Trial Info
Start Date :
November 9 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 30 2026
Estimated Enrollment :
798 Patients enrolled
Trial Details
Trial ID
NCT02276443
Start Date
November 9 2015
End Date
November 30 2026
Last Update
August 1 2025
Active Locations (5)
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1
MD Anderson in The Woodlands
Conroe, Texas, United States, 77384
2
M D Anderson Cancer Center
Houston, Texas, United States, 77030
3
MD Anderson West Houston
Houston, Texas, United States, 77079
4
MD Anderson League City
League City, Texas, United States, 77573