Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02276443 · ClinicalTrials.gov registry record · NA
Molecular Testing and Imaging in Improving Response in Patients With Stage I-III Triple-Negative Breast Cancer Receiving Chemotherapy MDACC Breast Moonshot Initiative
A NA study of Invasive Breast Carcinoma and Stage II Breast Cancer AJCC v6 and v7, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- NA
- Development phase
- 798
- Enrollment target
- 5
- Study locations
NCT02276443: Active NA study of Invasive Breast Carcinoma and Stage II Breast Cancer AJCC v6 and v7, sponsored by M.D. Anderson Cancer Center.
NCT02276443 is a NA study of Invasive Breast Carcinoma and Stage II Breast Cancer AJCC v6 and v7 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 798 participants, above the 467-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (71% higher). The trial reports 5 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02276443, a NA study of Invasive Breast Carcinoma and Stage II Breast Cancer AJCC v6 and v7, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 798 participants
- Enrollment target
- 5
- Study locations
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- DRUG Chemotherapy
- OTHER Immunotherapy
- PROCEDURE Ultrasonography
- PROCEDURE Lymph Node Biopsy
Study Locations (5)
Texas
- MD Anderson in The Woodlands - Conroe
- M D Anderson Cancer Center - Houston
- MD Anderson West Houston - Houston
- MD Anderson League City - League City
- MD Anderson in Sugar Land - Sugar Land
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 798 participants |
| Start Date | 2015-11-09 |
| Est. Completion | 2026-11-30 |
| Phase | NA |
What the registry record for NCT02276443 still lists
NCT02276443 is an interventional study that assigns participants to a tested intervention. The registered 798 participants enrollment target is mid-sized for trials with a published cap, above the 467-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (71% higher).
The record links to 10 conditions, with Invasive Breast Carcinoma appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02276443 lists 5 locations in 1 state (Texas).
Frequently Asked Questions
What is clinical trial NCT02276443 about?
NCT02276443 is a clinical study titled "Molecular Testing and Imaging in Improving Response in Patients With Stage I-III Triple-Negative Breast Cancer Receiving Chemotherapy MDACC Breast Moonshot Initiative". 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 diagno...
What is the current status of trial NCT02276443?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 798 participants. The study started on 2015-11-09. Estimated completion is 2026-11-30.
What conditions does trial NCT02276443 study?
This clinical trial studies the following conditions: Invasive Breast Carcinoma, Stage II Breast Cancer AJCC v6 and v7, Stage IIA Breast Cancer AJCC v6 and v7, Stage III Breast Cancer AJCC v7, Stage IB Breast Cancer AJCC v7.
What interventions are being tested in trial NCT02276443?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Chemotherapy (DRUG), Immunotherapy (OTHER), Ultrasonography (PROCEDURE), Lymph Node Biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT02276443?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02276443 being conducted?
This trial has 5 study locations across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Invasive Breast Carcinoma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02276443's enrollment target sits among peer trials
798 11th of 45 higher than 35 of 45 other Invasive Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Invasive Breast Carcinoma trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Multicenter Trial for Eliminating Breast Cancer Surgery or Radiotherapy in Exceptional Responders to Neoadjuvant Systemic Therapy
RECRUITING · NA
-
Pre-operative SABR With and Without Caloric Restriction for Early Stage Breast Cancer
RECRUITING · NA
-
Neoadjuvant Breast Cancer Time Restricted Eating
RECRUITING · NA
-
NearWave Optical Molecular Monitoring
RECRUITING · NA
-
Radiation Therapy Boost Before Surgery for the Treatment of Non-metastatic Breast Cancer
ACTIVE NOT RECRUITING · NA
-
Hypofractionated Regional Nodal Irradiation Clinical Trial for Women With Breast Cancer
ACTIVE NOT RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT06051058 · 798 participants · NA
Care Transitions App for Patients With Multiple Chronic Conditions
- NCT00695214 · 800 participants · Phase 2
Drug-Induced Sleep Endoscopy for Upper Airway Evaluation in Obstructive Sleep Apnea
- NCT03048201 · 800 participants · NA
Physica System Total Knee Replacement Registry Study
- NCT03792659 · 800 participants
The EXPLORE MG Registry for Myasthenia Gravis
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI