🏛️ Verified NIH Record • Updated 2026-03-31

Study to Evaluate Efficacy & Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer (NCT04851613)

A Phase Ib/III Study to Evaluate the Efficacy and Safety of Afuresertib Plus Fulvestrant in Patients With Locally Advanced or Metastatic HR+/HER2- Breast Cancer Who Failed Standard of Care Therapies

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Laekna Limited

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Providence St. Johns Health Center — Santa Monica, California

Age range: 18 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria ↗

📍 All Participating Trial Locations (55 Sites)

Showing the first 25 of 55 sites.

  • Providence St. Johns Health Center — Santa Monica, California
  • Piedmont Cancer Institute — Atlanta, Georgia
  • University of Iowa — Iowa City, Iowa
  • University of Mississippi Medical Center — Jackson, Mississippi
  • University of Vermont — Burlington, Vermont
  • Virginia Cancer Specialists — Fairfax, Virginia
  • The First Affiliated Hospital of Bengbu Medical College — Bengbu, Anhui
  • Anhui Provincial Cancer Hospital — Hefei, Anhui
  • Cancer Hospital Chinese Academy of Medical Sciences — Beijing, Beijing Municipality
  • Beijing Cancer Hospital — Beijing, Beijing Municipality
  • Peking Union Medical College Hospital (PUMCH) — Beijing, Beijing Municipality
  • The First Affiliated Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality
  • Chongqing University Cancer Hospital — Chongqing, Chongqing Municipality
  • Fujian Cancer Hospital — Fuzhou, Fujian
  • The First People's Hospital of Foshan — Foshan, Guangdong
  • Sun Yat-sen Memorial Hospital,Sun Yat-sen University — Guangzhou, Guangdong
  • Sun Yat-sen University Cancer Center — Guangzhou, Guangdong
  • Zhongshan People's Hospital — Zhongshan, Guangdong
  • Guangxi Zhuang Autonomous Region People's Hospital — Nanning, Guangxi
  • The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi
  • Affiliated Hospital of Hebei University — Baoding, Hebei
  • The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei
  • Tangshan People's Hospital — Tangshan, Hebei
  • Harbin Medical University Cancer Hospital — Harbin, Heilongjiang
  • Anyang cancer hospital — Anyang, Henan

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Breast Cancer clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗