LAE205INT3101: 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

About this Study

This purpose of this study is to find out if a new investigational drug Afuresertib in combination with Fulvestrant helps you better than Fulvestrant alone.

Sponsor Protocol ID:LAE205INT3101
IRB Number:UMMC-IRB-2022-87
Actively Enrolling
Phase 1
July 13, 2022
Eligibility Criteria
18 years old
Both Male and Female

Inclusion Criteria
  • 18 years of age or older
  • Histologically or cytologically confirmed hormone receptor positive, HER2 negative breast cancer
  • Females must be post-menopausal
  • Hormone receptor positive, HER2 negative breast cancer patients must have relapsed locally advance or metastatic disease AND have received 1 or 2 prior lines of systemic treatments¬†

Exclusion Criteria
  • Woman of child-bearing potential who has a positive urine pregnancy test prior to study treatment
  • Recent major surgery the required hospitalization from scheduled treatment starting date or have used IV antibiotics for infection
  • Additional known cancer that are progressing or have required active treatment within 3 year of scheduled treatment starting date
  • History of seizure or conditions the may cause them to seizure and require anti-epileptic medications
  • Known active CNS metastases and/or carcinomatous meningitis
  • Prior treatment with Fulvestrant or other selective estrogen degraders (SERDs)
  • Congestive heart failure
  • Uncontrolled hypertension
  • Hepatitis B active infection
  • Known psychiatric or substance abuse disorder
  • Pregnant or breastfeeding

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Participating Locations
Cancer Center and Research Institute - UMMC
University Hospital - UMMC
Contact Information
Contact Name: Jessie Solise
Phone Number: 601-984-1963
Principal Investigator:Tang, Shou J, M.D.
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