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NCT04243616 · ClinicalTrials.gov registry record · Phase 2
Cemiplimab in High-risk or Locally Advanced Luminal and Triple Negative Breast Cancer
A Phase 2 study of Invasive Breast Cancer, sponsored by Medical College of Wisconsin.
- Active
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT04243616: Active Phase 2 study of Invasive Breast Cancer, sponsored by Medical College of Wisconsin.
NCT04243616 is a Phase 2 study of Invasive Breast Cancer that is active but no longer recruiting, run by Medical College of Wisconsin. The registered enrollment target is 36 participants, below the 131-participant average among 19 other Invasive Breast Cancer trials with a reported enrollment target (73% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04243616, a Phase 2 study of Invasive Breast Cancer, is active but no longer recruiting, sponsored by Medical College of Wisconsin.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single-arm, open-label, phase 2 study that will enroll 36 subjects, who have pathologically proven diagnosis of invasive breast cancer, clinical stage tumor 1-3 (cT1-T3), node 0-3 (cN0-N3), metastasis 0 (cM0), hormone receptor positive (HR+) (estrogen-receptor-positive (ER+) and/or progesterone-receptor-positive (PR+) human epidermal growth factor receptor 2 (HER2) negative or hormone receptor-negative (HR-) (estrogen-receptor-negative (ER-) and progesterone-receptor-negative (PR-) human epidermal growth factor receptor 2 (HER2) negative/triple-negative breast cancer.
Primary Outcome
This is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Cemiplimab
- DRUG Doxorubicin
- DRUG Paclitaxel
- DRUG Carboplatin (not mandatory)
Study Locations (1)
Wisconsin
- Froedtert Hospital & Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2020-03-05 |
| Est. Completion | 2030-08-12 |
| Phase | Phase 2 |
What the registry record for NCT04243616 still lists
NCT04243616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 131-participant average among 19 other Invasive Breast Cancer trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Invasive Breast Cancer appearing as the primary indexed condition, and to 5 interventions - of which Cyclophosphamide is the first listed.
NCT04243616 reports a single indexed study location in Wisconsin.
Frequently Asked Questions
What is clinical trial NCT04243616 about?
NCT04243616 is a clinical study titled "Cemiplimab in High-risk or Locally Advanced Luminal and Triple Negative Breast Cancer". This is a single-arm, open-label, phase 2 study that will enroll 36 subjects, who have pathologically proven diagnosis of invasive breast cancer, clinical stage tumor 1-3 (cT1-T3), node 0-3 (cN0-N3), metastasis 0 (cM0), hormone receptor positive (HR+) (estrogen-receptor-positive (ER+) and/or progest...
What is the current status of trial NCT04243616?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2020-03-05. Estimated completion is 2030-08-12.
What conditions does trial NCT04243616 study?
This clinical trial studies the following conditions: Invasive Breast Cancer.
What interventions are being tested in trial NCT04243616?
The interventions under investigation include: Cyclophosphamide (DRUG), Cemiplimab (DRUG), Doxorubicin (DRUG), Paclitaxel (DRUG), Carboplatin (not mandatory) (DRUG).
Who is sponsoring clinical trial NCT04243616?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04243616 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Invasive Breast Cancer
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 NCT04243616's enrollment target sits among peer trials
36 18th of 19 higher than 2 of 19 other Invasive Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Invasive 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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