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NCT01334021 · ClinicalTrials.gov registry record · Phase 2
Genetic Testing in Predicting Tumor Response in Patients With Stage I-III HER2 Negative Invasive Breast Cancer
A Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 1,100
- Enrollment target
- 1
- Study location
NCT01334021: Active Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by M.D. Anderson Cancer Center.
NCT01334021 is a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8 that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 1,100 participants, above the 292-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (277% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01334021, a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 1,100 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well genetic testing works in predicting tumor response in patients with stage I-III HER2 negative invasive breast cancer. Genetic testing is a procedure that tests tumor samples to learn if certain genes are activated (turned on) in the tumor and if the activation of these genes may predict if the tumor will be sensitive or resistant to routine breast cancer treatments, such as chemotherapy or hormonal therapy.
Primary Outcome
The study will use the methods of Thall et al. to monitor the ability to classify patients into 1 of 4 groups (success rate) throughout the trial. Will use summary statistics to describe the demographic and clinical characteristics of patients overall and within each subgroup (Groups A-D).
Conditions Studied
Interventions
- PROCEDURE Biopsy
- OTHER Genetic Testing
- PROCEDURE Conventional Surgery
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,100 participants |
| Start Date | 2011-05-31 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 2 |
What the registry record for NCT01334021 still lists
NCT01334021 is an interventional study that assigns participants to a tested intervention. Its 1,100 participants enrollment target places it among the larger protocols in the corpus, above the 292-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (277% higher).
The record links to 10 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Biopsy is the first listed.
NCT01334021 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT01334021 about?
NCT01334021 is a clinical study titled "Genetic Testing in Predicting Tumor Response in Patients With Stage I-III HER2 Negative Invasive Breast Cancer". This phase II trial studies how well genetic testing works in predicting tumor response in patients with stage I-III HER2 negative invasive breast cancer. Genetic testing is a procedure that tests tumor samples to learn if certain genes are activated (turned on) in the tumor and if the activation of...
What is the current status of trial NCT01334021?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 1,100 participants. The study started on 2011-05-31. Estimated completion is 2026-12-31.
What conditions does trial NCT01334021 study?
This clinical trial studies the following conditions: Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8.
What interventions are being tested in trial NCT01334021?
The interventions under investigation include: Biopsy (PROCEDURE), Genetic Testing (OTHER), Conventional Surgery (PROCEDURE).
Who is sponsoring clinical trial NCT01334021?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01334021 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01334021's enrollment target sits among peer trials
1,100 9th of 84 higher than 76 of 84 other Anatomic Stage III Breast Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anatomic Stage III Breast Cancer AJCC v8 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.
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