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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04851613
The ClinicalTrials.gov registry entry for NCT04851613 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 256 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (91% lower). The listed sponsor is Laekna Limited, which has 4 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 12 distinct geographic areas - top geographies include 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.
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