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NCT04862585 · ClinicalTrials.gov registry record · Phase 2
Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel
A Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by Ohio State University Comprehensive Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 130
- Enrollment target
- 1
- Study location
NCT04862585: Completed Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, sponsored by Ohio State University Comprehensive Cancer Center.
NCT04862585 is a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8 that has completed, run by Ohio State University Comprehensive Cancer Center. The registered enrollment target is 130 participants, below the 303-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 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
NCT04862585, a Phase 2 study of Anatomic Stage III Breast Cancer AJCC v8 and Anatomic Stage II Breast Cancer AJCC v8, has completed, sponsored by Ohio State University Comprehensive Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 130 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II/III trial investigates the difference in rates of infusion hypersensitivity reaction in patients with breast cancer who are receiving paclitaxel alone or in combination with other cancer drugs which require parenteral rescue medication after stopping standard pre-medications (dexamethasone, diphenhydramine, famotidine/cimetidine/ranitidine), compared to continuing premedications. Paclitaxel is a drug used to treat breast cancer, ovarian cancer, and autoimmune deficiency syndrome (AIDS)-related Kaposi sarcoma. It blocks cell growth by stopping cell division and may kill cancer cells. It is a type of antimitotic agent. However, there are side-effects and toxicities associated with repeat exposure to this pre-medication regimen. With prolonged use of paclitaxel, especially during weekly regimens, patients are exposed to repeat doses of drugs that prevent hypersensitivity reactions. Side effects include, but are not limited to, insomnia, gastritis, fluid retention, weight gain, mood changes and immune suppression. The information gained from this study may positively influence clinical practice and help researchers develop methods to safely stop pre-medications.
Primary Outcome
The proportion of patients having infusion HSR of grade 2 or greater requiring parental treatment (rescue medications) will be estimated along with a 95% confidence interval. The difference in proportions of patients with grade 2 or greater infusion HSR needing rescue medication will be estimated along with a 95% confidence interval using the Z-test of normal approximations of the binomial distributions. As a sensitivity analysis, will repeat the analysis including patients assigned to the disco
Conditions Studied
Interventions
- DRUG Paclitaxel
- DRUG Dexamethasone
- DRUG Diphenhydramine
- DRUG Famotidine
- DRUG Cimetidine
Study Locations (1)
Ohio
- Ohio State University Comprehensive Cancer Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 130 participants |
| Start Date | 2021-10-07 |
| Est. Completion | 2024-06-21 |
| Phase | Phase 2 |
What the finished NCT04862585 record still lists
NCT04862585 is an interventional study that assigns participants to a tested intervention. The registered 130 participants enrollment target is mid-sized for trials with a published cap, below the 303-participant average among 84 other Anatomic Stage III Breast Cancer AJCC v8 trials with a reported enrollment target (57% lower).
The record links to 10 conditions, with Anatomic Stage III Breast Cancer AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Paclitaxel is the first listed.
NCT04862585 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04862585 about?
NCT04862585 is a clinical study titled "Safely Stopping Pre-medications in Patients With Breast Cancer Who Are Receiving Paclitaxel". This phase II/III trial investigates the difference in rates of infusion hypersensitivity reaction in patients with breast cancer who are receiving paclitaxel alone or in combination with other cancer drugs which require parenteral rescue medication after stopping standard pre-medications (dexametha...
What is the current status of trial NCT04862585?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 130 participants. The study started on 2021-10-07. Estimated completion is 2024-06-21.
What conditions does trial NCT04862585 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 NCT04862585?
The interventions under investigation include: Paclitaxel (DRUG), Dexamethasone (DRUG), Diphenhydramine (DRUG), Famotidine (DRUG), Cimetidine (DRUG).
Who is sponsoring clinical trial NCT04862585?
This trial is sponsored by Ohio State University Comprehensive Cancer Center, which has 341 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04862585 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04862585's enrollment target sits among peer trials
130 31st of 84 higher than 54 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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