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NCT02187991 · ClinicalTrials.gov registry record · Phase 2
Study to Compare Alisertib With Paclitaxel vs. Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer
A Phase 2 study, sponsored by US Oncology Research.
- Completed
- Registry status
- Phase 2
- Development phase
- 169
- Enrollment target
NCT02187991: Completed Phase 2 study, sponsored by US Oncology Research.
NCT02187991 is a Phase 2 study that has completed, run by US Oncology Research. The registered enrollment target is 169 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02187991, a Phase 2 study, has completed, sponsored by US Oncology Research.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 169 participants
- Enrollment target
Study Summary
The goal of this clinical research study is to learn if the study drug, alisertib (MLN8237), in combination with chemotherapy (paclitaxel), can shrink or slow tumor growth in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative or HR-negative, HER2-negative (triple negative) locally recurrent or metastatic breast cancer (MBC). The safety of alisertib in combination with paclitaxel will also be studied. The physical state of the patient, symptoms, changes in the size of the tumor, and laboratory findings obtained while on-study will help the research team decide if alisertib plus paclitaxel is safe and effective in patients with this type of breast cancer. Alisertib belongs to a group of drugs called Aurora kinase inhibitors. Alisertib blocks the activity of Aurora A kinase, a protein that is involved in tumor cell multiplication and survival. Aurora A kinase is expressed at higher than normal levels in many types of cancer, including breast cancer, and preclinical studies suggest that blocking the activity of this protein can lead to the death of cancer cells. Paclitaxel is a chemotherapy drug commonly used to treat many different kinds of cancer, including metastatic breast cancer. The reason to combine alisertib and paclitaxel is that in cancer therapy, combinations of drugs are often more effective as a treatment than either of the same drugs used alone.
Primary Outcome
Measurement of tumors (sum of longest diameters) every 8 weeks for CT/MRI and photographs, and every 12 weeks for bone scan, if applicable. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions (plus an absolute increase of at least 5 mm), or a measurable increase in a non-target lesion, or the appearance of new lesions
Interventions
- DRUG Paclitaxel
- DRUG Alisertib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2015-02-12 |
| Est. Completion | 2024-08-01 |
| Phase | Phase 2 |
What the finished NCT02187991 record still lists
NCT02187991 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 2 interventions - of which Paclitaxel is the first listed.
NCT02187991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02187991 about?
NCT02187991 is a clinical study titled "Study to Compare Alisertib With Paclitaxel vs. Paclitaxel Alone in Metastatic or Locally Recurrent Breast Cancer". The goal of this clinical research study is to learn if the study drug, alisertib (MLN8237), in combination with chemotherapy (paclitaxel), can shrink or slow tumor growth in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative or HR-negative, HER2-nega...
What is the current status of trial NCT02187991?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 169 participants. The study started on 2015-02-12. Estimated completion is 2024-08-01.
What interventions are being tested in trial NCT02187991?
The interventions under investigation include: Paclitaxel (DRUG), Alisertib (DRUG).
Who is sponsoring clinical trial NCT02187991?
This trial is sponsored by US Oncology Research, which has 27 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02187991's enrollment target sits among peer trials
169 403rd of 2000 higher than 1,598 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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