Gene test could guide breast cancer treatment to boost survival
NCT ID NCT02276443
First seen Jul 15, 2026 · Last updated Jul 16, 2026 · Updated 1 time
Summary
This study tests whether analyzing the genetic makeup of a patient's triple-negative breast cancer tumor can help doctors choose the most effective treatment. Patients with newly diagnosed, early-stage triple-negative breast cancer receive either standard chemotherapy or a personalized treatment plan based on their tumor's genetic signature. The goal is to see if this tailored approach leads to better tumor shrinkage and survival compared to standard care alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- standard chemotherapy or immunotherapy, assigned based on tumor genomic testing
- What this could lead to
- If successful, this approach could lead to more effective, personalized treatment plans for triple-negative breast cancer, potentially improving survival rates.
- What could go wrong
- This is an early-stage framework study, not a direct test of a new drug. The personalized approach may not improve outcomes over standard care, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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798 people
The number who actually took part.
- Started
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Nov 2015
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 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 - 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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MD Anderson League City
League City, Texas, 77573, United States
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MD Anderson West Houston
Houston, Texas, 77079, United States
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MD Anderson in Sugar Land
Sugar Land, Texas, 77478, United States
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MD Anderson in The Woodlands
Conroe, Texas, 77384, United States
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