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NCT04434040 · ClinicalTrials.gov registry record · Phase 2
Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)
A Phase 2 study of Breast Cancer and Triple Negative Breast Cancer, sponsored by Dana-Farber Cancer Institute.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 7
- Study locations
NCT04434040: Recruiting Phase 2 study of Breast Cancer and Triple Negative Breast Cancer, sponsored by Dana-Farber Cancer Institute.
NCT04434040 is a Phase 2 study of Breast Cancer and Triple Negative Breast Cancer that is actively recruiting participants, run by Dana-Farber Cancer Institute. The registered enrollment target is 40 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 7 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04434040, a Phase 2 study of Breast Cancer and Triple Negative Breast Cancer, is actively recruiting participants, sponsored by Dana-Farber Cancer Institute.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to determine if a combination of two drugs sacituzumab govitecan and atezolizumab works as a treatment for residual cancer in the breast or lymph nodes and have circulating tumor DNA in the blood. This research study involves the following investigational drugs: * Sacituzumab govitecan * Atezolizumab
Primary Outcome
Clearance of tumor cfDNA after 18 weeks, it will be tested using a one-sided one-sample binomial exact test (alpha 5%) against a null hypothesis value of 7% false negatives.
Conditions Studied
Interventions
- DRUG Sacituzumab govitecan
- DRUG Atezolizumab
Study Locations (7)
Illinois
- University of Chicago Medical Center - Chicago
- University of Chicago Comprehensive Cancer Center at Silver Cross Hospital - New Lenox
- University of Chicago Medical Center for Advanced Care Orland Park - Orland Park
California
- University of California San Francisco - San Francisco
Massachusetts
- Dana-Farber Cancer Institute - Boston
Pennsylvania
- University of Pennsylvania-Abramson Cancer Center - Philadelphia
Tennessee
- Vanderbilt-Ingram Cancer Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2020-07-02 |
| Est. Completion | 2027-12-30 |
| Phase | Phase 2 |
What NCT04434040 shows while recruiting
NCT04434040 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Sacituzumab govitecan is the first listed.
NCT04434040 lists 7 locations in 5 states (Illinois, California, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT04434040 about?
NCT04434040 is a clinical study titled "Atezolizumab + Sacituzumab Govitecan to Prevent Recurrence in TNBC (ASPRIA)". The purpose of this study is to determine if a combination of two drugs sacituzumab govitecan and atezolizumab works as a treatment for residual cancer in the breast or lymph nodes and have circulating tumor DNA in the blood. This research study involves the following investigational drugs: * Saci...
What is the current status of trial NCT04434040?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2020-07-02. Estimated completion is 2027-12-30.
What conditions does trial NCT04434040 study?
This clinical trial studies the following conditions: Breast Cancer, Triple Negative Breast Cancer, Circulating Tumor DNA, Residual Cancer.
What interventions are being tested in trial NCT04434040?
The interventions under investigation include: Sacituzumab govitecan (DRUG), Atezolizumab (DRUG).
Who is sponsoring clinical trial NCT04434040?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04434040 being conducted?
This trial has 7 study locations across California, Illinois, Massachusetts, Pennsylvania, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for 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 NCT04434040's enrollment target sits among peer trials
40 876th of 1224 higher than 325 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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