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NCT03901339 · ClinicalTrials.gov registry record · Phase 3
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer
A Phase 3 study, sponsored by Gilead Sciences.
- Completed
- Registry status
- Phase 3
- Development phase
- 543
- Enrollment target
NCT03901339: Completed Phase 3 study, sponsored by Gilead Sciences.
NCT03901339 is a Phase 3 study that has completed, run by Gilead Sciences. The registered enrollment target is 543 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03901339, a Phase 3 study, has completed, sponsored by Gilead Sciences.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 543 participants
- Enrollment target
Study Summary
The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).
Primary Outcome
PFS was defined as the time from the date of randomization to the date of the first documentation of disease progression or death (whichever occurred first) according to BICR using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1). Disease progression was defined as an increase of greater than 20% in the sum of the longest diameter (LD) of target lesions and a 5 mm absolute increase, taking as a reference the smallest sum LD recorded since the baseline assessment or the appea
Interventions
- DRUG Capecitabine
- DRUG Gemcitabine
- DRUG Eribulin
- DRUG Vinorelbine
- DRUG Sacituzumab Govitecan-hziy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 543 participants |
| Start Date | 2019-05-08 |
| Est. Completion | 2023-10-20 |
| Phase | Phase 3 |
What the finished NCT03901339 record still lists
NCT03901339 is an interventional study that assigns participants to a tested intervention. The registered 543 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (30% lower).
The record links to 0 conditions, and to 5 interventions - of which Capecitabine is the first listed.
NCT03901339 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03901339 about?
NCT03901339 is a clinical study titled "Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer". The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC...
What is the current status of trial NCT03901339?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 543 participants. The study started on 2019-05-08. Estimated completion is 2023-10-20.
What interventions are being tested in trial NCT03901339?
The interventions under investigation include: Capecitabine (DRUG), Gemcitabine (DRUG), Eribulin (DRUG), Vinorelbine (DRUG), Sacituzumab Govitecan-hziy (DRUG).
Who is sponsoring clinical trial NCT03901339?
This trial is sponsored by Gilead Sciences, which has 504 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03901339's enrollment target sits among peer trials
543 694th of 2000 higher than 1,307 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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