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NCT04494425 · ClinicalTrials.gov registry record · Phase 3
Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer
A Phase 3 study of Advanced or Metastatic Breast Cancer, sponsored by AstraZeneca.
- Active
- Registry status
- Phase 3
- Development phase
- 866
- Enrollment target
- 20
- Study locations
NCT04494425: Active Phase 3 study of Advanced or Metastatic Breast Cancer, sponsored by AstraZeneca.
NCT04494425 is a Phase 3 study of Advanced or Metastatic Breast Cancer that is active but no longer recruiting, run by AstraZeneca. The registered enrollment target is 866 participants, above the 136-participant average among 3 other Advanced or Metastatic Breast Cancer trials with a reported enrollment target (537% higher). The trial reports 20 study locations across 18 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04494425, a Phase 3 study of Advanced or Metastatic Breast Cancer, is active but no longer recruiting, sponsored by AstraZeneca.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 866 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.
Primary Outcome
PFS per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1) assessed by BICR was defined as the time from the date of randomization until the date of PD, as defined or death (by any cause in the absence of progression) regardless of whether the participant withdrew from randomized therapy or received another anticancer therapy prior to progression. PD was defined as at least a 20% increase in the sum of diameters of target lesions (TLs), taking as reference the smallest previou
Conditions Studied
Interventions
- DRUG Capecitabine
- DRUG Paclitaxel
- DRUG Nab-Paclitaxel
- DRUG Trastuzumab deruxtecan
Study Locations (20)
California
- Research Site - Duarte
- Research Site - Los Angeles
Colorado
- Research Site - Aurora
- Research Site - Lakewood
Arizona
- Research Site - Scottsdale
Arkansas
- Research Site - Springdale
District of Columbia
- Research Site - Washington D.C.
Florida
- Research Site - Jacksonville
Kansas
- Research Site - Kansas City
Kentucky
- Research Site - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 866 participants |
| Start Date | 2020-07-24 |
| Est. Completion | 2026-06-19 |
| Phase | Phase 3 |
What the registry record for NCT04494425 still lists
NCT04494425 is an interventional study that assigns participants to a tested intervention. The registered 866 participants enrollment target is mid-sized for trials with a published cap, above the 136-participant average among 3 other Advanced or Metastatic Breast Cancer trials with a reported enrollment target (537% higher).
The record links to 1 condition, with Advanced or Metastatic Breast Cancer appearing as the primary indexed condition, and to 4 interventions - of which Capecitabine is the first listed.
NCT04494425 names 20 study sites across 18 states, led by California, Colorado, Arizona.
Frequently Asked Questions
What is clinical trial NCT04494425 about?
NCT04494425 is a clinical study titled "Study of Trastuzumab Deruxtecan (T-DXd) vs Investigator's Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer". This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in t...
What is the current status of trial NCT04494425?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 866 participants. The study started on 2020-07-24. Estimated completion is 2026-06-19.
What conditions does trial NCT04494425 study?
This clinical trial studies the following conditions: Advanced or Metastatic Breast Cancer.
What interventions are being tested in trial NCT04494425?
The interventions under investigation include: Capecitabine (DRUG), Paclitaxel (DRUG), Nab-Paclitaxel (DRUG), Trastuzumab deruxtecan (DRUG).
Who is sponsoring clinical trial NCT04494425?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04494425 being conducted?
This trial has 20 study locations across Arizona, Arkansas, California, Colorado, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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