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NCT02536794 · ClinicalTrials.gov registry record · Phase 2
MEDI4736 and Tremelimumab in Treating Patients With Metastatic HER2 Negative Breast Cancer
A Phase 2 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 2
- Study locations
NCT02536794: Completed Phase 2 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, sponsored by Northwestern University.
NCT02536794 is a Phase 2 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma that has completed, run by Northwestern University. The registered enrollment target is 30 participants, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (55% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02536794, a Phase 2 study of Stage IV Breast Cancer and Recurrent Breast Carcinoma, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 2
- Study locations
Study Summary
The main purpose of this study is to determine the anti-tumor activity of MEDI4736 in combination with tremelimumab in patients with metastatic HER2-negative breast cancer. Both MEDI4736 and tremelimumab are antibodies (proteins used by the immune system to fight infections and cancers). MEDI4736 attaches to a protein in tumors called PD-L1. It may prevent cancer growth by helping certain blood cells of the immune system get rid of the tumor. Tremelimumab stimulates (wakes up) the immune system to attack the tumor by inhibiting a protein molecule called CTLA-4 on immune cells. Combining the actions of these drugs may result in better treatment options for patients with breast cancer.
Primary Outcome
Overall response rate is defined as the number of patients with partial response (PR), plus those with complete response (CR) using the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1 with the following definitions: Complete Response - Disappearance of all lesions Partial Response - At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- BIOLOGICAL Tremelimumab
- OTHER Pharmacological Study
- BIOLOGICAL Anti-B7H1 Monoclonal Antibody MEDI4736
Study Locations (2)
Illinois
- Northwestern University - Chicago
- Northwestern University- Lake Forest Hospital - Lake Forest
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2016-01-14 |
| Est. Completion | 2021-01-22 |
| Phase | Phase 2 |
What the finished NCT02536794 record still lists
NCT02536794 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 66-participant average among 30 other Stage IV Breast Cancer trials with a reported enrollment target (55% lower).
The record links to 5 conditions, with Stage IV Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT02536794 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT02536794 about?
NCT02536794 is a clinical study titled "MEDI4736 and Tremelimumab in Treating Patients With Metastatic HER2 Negative Breast Cancer". The main purpose of this study is to determine the anti-tumor activity of MEDI4736 in combination with tremelimumab in patients with metastatic HER2-negative breast cancer. Both MEDI4736 and tremelimumab are antibodies (proteins used by the immune system to fight infections and cancers). MEDI4736 at...
What is the current status of trial NCT02536794?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2016-01-14. Estimated completion is 2021-01-22.
What conditions does trial NCT02536794 study?
This clinical trial studies the following conditions: Stage IV Breast Cancer, Recurrent Breast Carcinoma, HER2/Neu Negative, Estrogen Receptor Negative, Estrogen Receptor Positive.
What interventions are being tested in trial NCT02536794?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Tremelimumab (BIOLOGICAL), Pharmacological Study (OTHER), Anti-B7H1 Monoclonal Antibody MEDI4736 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02536794?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02536794 being conducted?
This trial has 2 study locations across Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02536794's enrollment target sits among peer trials
30 16th of 30 higher than 13 of 30 other Stage IV Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage IV Breast Cancer 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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