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NCT04009044 · ClinicalTrials.gov registry record · Phase 2
Topical Afimoxifene in Treating Patients With Breast Cancer Who Have Undergone Radiation Therapy on One Breast
A Phase 2 study of Invasive Breast Carcinoma and Cancer Survivor, sponsored by Northwestern University.
- Active
- Registry status
- Phase 2
- Development phase
- 156
- Enrollment target
- 2
- Study locations
NCT04009044: Active Phase 2 study of Invasive Breast Carcinoma and Cancer Survivor, sponsored by Northwestern University.
NCT04009044 is a Phase 2 study of Invasive Breast Carcinoma and Cancer Survivor that is active but no longer recruiting, run by Northwestern University. The registered enrollment target is 156 participants, below the 482-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (68% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04009044, a Phase 2 study of Invasive Breast Carcinoma and Cancer Survivor, is active but no longer recruiting, sponsored by Northwestern University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 156 participants
- Enrollment target
- 2
- Study locations
Study Summary
This phase II trial studies how well topical afimoxifene works in treating patients with breast cancer who have undergone radiation therapy on one breast. Topical afimoxifene is a quick-drying medicated gel that may block the growth of breast cancer cells when applied to the breast skin. The purpose of this research is to determine what effect, if any, differences in skin type between women have on the delivery of topical afimoxifene to the breast tissue, and whether radiation affects the delivery of topical afimoxifene to breast tissue.
Primary Outcome
Univariate analyses will relate each characteristic to tissue drug concentration using either correlation analysis for continuous characteristics or a t-test, analysis of variance or rank sum test for categorical characteristics. Multiple linear regression modelling will be used to select those characteristics that provide the strongest independent contribution to the model.
Conditions Studied
Interventions
- OTHER Questionnaire Administration
- PROCEDURE Core Biopsy
- DRUG Afimoxifene
Study Locations (2)
Illinois
- Northwestern University - Chicago
- University of Illinois Cancer Center - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2020-02-17 |
| Est. Completion | 2026-06-25 |
| Phase | Phase 2 |
What the registry record for NCT04009044 still lists
NCT04009044 is an interventional study that assigns participants to a tested intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap, below the 482-participant average among 45 other Invasive Breast Carcinoma trials with a reported enrollment target (68% lower).
The record links to 3 conditions, with Invasive Breast Carcinoma appearing as the primary indexed condition, and to 3 interventions - of which Questionnaire Administration is the first listed.
NCT04009044 reports a single indexed study location in Illinois.
Frequently Asked Questions
What is clinical trial NCT04009044 about?
NCT04009044 is a clinical study titled "Topical Afimoxifene in Treating Patients With Breast Cancer Who Have Undergone Radiation Therapy on One Breast". This phase II trial studies how well topical afimoxifene works in treating patients with breast cancer who have undergone radiation therapy on one breast. Topical afimoxifene is a quick-drying medicated gel that may block the growth of breast cancer cells when applied to the breast skin. The purpose...
What is the current status of trial NCT04009044?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 156 participants. The study started on 2020-02-17. Estimated completion is 2026-06-25.
What conditions does trial NCT04009044 study?
This clinical trial studies the following conditions: Invasive Breast Carcinoma, Cancer Survivor, Ductal Breast Carcinoma in Situ.
What interventions are being tested in trial NCT04009044?
The interventions under investigation include: Questionnaire Administration (OTHER), Core Biopsy (PROCEDURE), Afimoxifene (DRUG).
Who is sponsoring clinical trial NCT04009044?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04009044 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
Similar trials for Invasive Breast Carcinoma
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 NCT04009044's enrollment target sits among peer trials
156 20th of 45 higher than 26 of 45 other Invasive Breast Carcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Invasive Breast Carcinoma 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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