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NCT04895761 · ClinicalTrials.gov registry record · Phase 1
Neoadjuvant DPX-Survivac Aromatase Inhibition, Radiotherapy or Cyclophosphamide in HR+HER2- Breast Cancer
A Phase 1 study of Breast Cancer, sponsored by Providence Health & Services.
- Active
- Registry status
- Phase 1
- Development phase
- 6
- Enrollment target
- 1
- Study location
NCT04895761: Active Phase 1 study of Breast Cancer, sponsored by Providence Health & Services.
NCT04895761 is a Phase 1 study of Breast Cancer that is active but no longer recruiting, run by Providence Health & Services. The registered enrollment target is 6 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04895761, a Phase 1 study of Breast Cancer, is active but no longer recruiting, sponsored by Providence Health & Services.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 6 participants
- Enrollment target
- 1
- Study location
Study Summary
The study seeks to establish the safety of neoadjuvant aromatase inhibitor with: DPX-Survivac, DPX-Survivac plus radiation, or DPX-Survivac with cyclophosphamide in stage I to III HR+HER2- breast cancer. There will be sequential enrollment into 3 arms with an anticipated N=6 participants per arm for N=18 participants in total. All participants will receive letrozole 2.5 mg daily during the 6 weeks of neoadjuvant therapy. Neoadjuvant therapy occurs weeks 1-6, with standard of care surgery taking place week 7 to 9.
Primary Outcome
yes/no outcome variable, ascertained for each individual subject, and reported as a binomial proportion for each arm. Safety will be reported for all subjects who receive at least one dose of drug/radiation/study therapy
Conditions Studied
Interventions
- DRUG Letrozole 2.5mg
- BIOLOGICAL DPX-Survivac
- DRUG Cyclophosphamide 50mg
- RADIATION XRT 10Gy x2
Study Locations (1)
Oregon
- Providence Portland Medical Center - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2021-09-10 |
| Est. Completion | 2026-09-01 |
| Phase | Phase 1 |
What the registry record for NCT04895761 still lists
NCT04895761 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 6 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (100% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Letrozole 2.5mg is the first listed.
NCT04895761 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT04895761 about?
NCT04895761 is a clinical study titled "Neoadjuvant DPX-Survivac Aromatase Inhibition, Radiotherapy or Cyclophosphamide in HR+HER2- Breast Cancer". The study seeks to establish the safety of neoadjuvant aromatase inhibitor with: DPX-Survivac, DPX-Survivac plus radiation, or DPX-Survivac with cyclophosphamide in stage I to III HR+HER2- breast cancer. There will be sequential enrollment into 3 arms with an anticipated N=6 participants per arm for...
What is the current status of trial NCT04895761?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 6 participants. The study started on 2021-09-10. Estimated completion is 2026-09-01.
What conditions does trial NCT04895761 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT04895761?
The interventions under investigation include: Letrozole 2.5mg (DRUG), DPX-Survivac (BIOLOGICAL), Cyclophosphamide 50mg (DRUG), XRT 10Gy x2 (RADIATION).
Who is sponsoring clinical trial NCT04895761?
This trial is sponsored by Providence Health & Services, which has 69 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04895761 being conducted?
This trial has 1 study location across Oregon. 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 NCT04895761's enrollment target sits among peer trials
6 1209th of 1224 higher than 15 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other 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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