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NCT04851613 · ClinicalTrials.gov registry record · Phase 3
Study to Evaluate Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer
A Phase 3 study of Breast Cancer, sponsored by Laekna Limited.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 256
- Enrollment target
- 20
- Study locations
NCT04851613: Recruiting Phase 3 study of Breast Cancer, sponsored by Laekna Limited.
NCT04851613 is a Phase 3 study of Breast Cancer that is actively recruiting participants, run by Laekna Limited. The registered enrollment target is 256 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04851613, a Phase 3 study of Breast Cancer, is actively recruiting participants, sponsored by Laekna Limited.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 256 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study LAE205INT3101 is a Phase Ib/III study to evaluate the efficacy and safety of the combination therapy with afuresertib plus fulvestrant (afuresertib/placebo plus fulvestrant in Phase III) in patients with HR+/HER2- breast cancer who have failed 1 to 2 prior lines of endocrine therapy, and/or CDK4/6 inhibitor (up to 1 therapy), and/or chemotherapy (up to 1 chemotherapy) as described in the inclusion criteria.
Primary Outcome
Phase I: Anti-tumor activity of the combination therapy with afuresertib plus fulvestrant in patients with HR+/HER2- BC
Conditions Studied
Interventions
- DRUG Afuresertib
- DRUG Afuresertib/placebo
Study Locations (20)
Guangdong
- The First People's Hospital of Foshan - Foshan
- Sun Yat-sen Memorial Hospital，Sun Yat-sen University - Guangzhou
- Sun Yat-sen University Cancer Center - Guangzhou
- Zhongshan People's Hospital - Zhongshan
Beijing Municipality
- Cancer Hospital Chinese Academy of Medical Sciences - Beijing
- Beijing Cancer Hospital - Beijing
- Peking Union Medical College Hospital (PUMCH) - Beijing
Anhui
- The First Affiliated Hospital of Bengbu Medical College - Bengbu
- Anhui Provincial Cancer Hospital - Hefei
Chongqing Municipality
- The First Affiliated Hospital of Chongqing Medical University - Chongqing
- Chongqing University Cancer Hospital - Chongqing
Guangxi
- Guangxi Zhuang Autonomous Region People's Hospital - Nanning
- The First Affiliated Hospital of Guangxi Medical University - Nanning
California
- Providence St. Johns Health Center - Santa Monica
Georgia
- Piedmont Cancer Institute - Atlanta
Iowa
- University of Iowa - Iowa City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 256 participants |
| Start Date | 2022-02-18 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 3 |
What NCT04851613 shows while recruiting
NCT04851613 is an interventional study that assigns participants to a tested intervention. The registered 256 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Afuresertib is the first listed.
NCT04851613 names 20 study sites across 12 states, led by Guangdong, Beijing Municipality, Anhui.
Frequently Asked Questions
What is clinical trial NCT04851613 about?
NCT04851613 is a clinical study titled "Study to Evaluate Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer". Study LAE205INT3101 is a Phase Ib/III study to evaluate the efficacy and safety of the combination therapy with afuresertib plus fulvestrant (afuresertib/placebo plus fulvestrant in Phase III) in patients with HR+/HER2- breast cancer who have failed 1 to 2 prior lines of endocrine therapy, and/or CD...
What is the current status of trial NCT04851613?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 256 participants. The study started on 2022-02-18. Estimated completion is 2026-12-30.
What conditions does trial NCT04851613 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT04851613?
The interventions under investigation include: Afuresertib (DRUG), Afuresertib/placebo (DRUG).
Who is sponsoring clinical trial NCT04851613?
This trial is sponsored by Laekna Limited, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04851613 being conducted?
This trial has 20 study locations across California, Georgia, Iowa, Mississippi, Vermont. 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 NCT04851613's enrollment target sits among peer trials
256 318th of 1224 higher than 907 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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