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NCT02411656 · ClinicalTrials.gov registry record · Phase 2
Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy
A Phase 2 study of HER2/Neu Negative and Triple-Negative Breast Carcinoma, sponsored by M.D. Anderson Cancer Center.
- Active
- Registry status
- Phase 2
- Development phase
- 71
- Enrollment target
- 1
- Study location
NCT02411656: Active Phase 2 study of HER2/Neu Negative and Triple-Negative Breast Carcinoma, sponsored by M.D. Anderson Cancer Center.
NCT02411656 is a Phase 2 study of HER2/Neu Negative and Triple-Negative Breast Carcinoma that is active but no longer recruiting, run by M.D. Anderson Cancer Center. The registered enrollment target is 71 participants, below the 165-participant average among 28 other HER2/Neu Negative trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02411656, a Phase 2 study of HER2/Neu Negative and Triple-Negative Breast Carcinoma, is active but no longer recruiting, sponsored by M.D. Anderson Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 71 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well pembrolizumab works in treating patients with stage IV inflammatory breast cancer or triple-negative breast cancer that has spread to other places in the body (metastatic) or has come back (recurrent), and who have achieved clinical response or stable disease to prior chemotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
Primary Outcome
The disease control rate (DCR) was assessed. The DCR was defined as the proportion of all treated patients with a lack of progression within 4 months as determined by radiologic imaging or clinical assessment.
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- OTHER Laboratory Biomarker Analysis
Study Locations (1)
Texas
- M D Anderson Cancer Center - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2015-06-11 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
What the registry record for NCT02411656 still lists
NCT02411656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 165-participant average among 28 other HER2/Neu Negative trials with a reported enrollment target (57% lower).
The record links to 9 conditions, with HER2/Neu Negative appearing as the primary indexed condition, and to 2 interventions - of which Pembrolizumab is the first listed.
NCT02411656 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02411656 about?
NCT02411656 is a clinical study titled "Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy". This phase II trial studies how well pembrolizumab works in treating patients with stage IV inflammatory breast cancer or triple-negative breast cancer that has spread to other places in the body (metastatic) or has come back (recurrent), and who have achieved clinical response or stable disease to ...
What is the current status of trial NCT02411656?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2015-06-11. Estimated completion is 2028-12-31.
What conditions does trial NCT02411656 study?
This clinical trial studies the following conditions: HER2/Neu Negative, Triple-Negative Breast Carcinoma, Estrogen Receptor Negative, Progesterone Receptor Negative, Edema.
What interventions are being tested in trial NCT02411656?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Laboratory Biomarker Analysis (OTHER).
Who is sponsoring clinical trial NCT02411656?
This trial is sponsored by M.D. Anderson Cancer Center, which has 2,692 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02411656 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
Similar trials for HER2/Neu Negative
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 NCT02411656's enrollment target sits among peer trials
71 13th of 28 higher than 16 of 28 other HER2/Neu Negative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2/Neu Negative 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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