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
🩺 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 ChecklistFull 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.
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💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.