A Randomized, Placebo-controlled, Double-blind, Multicenter Phase 2 Study of Atezolizumab With or Without Entinostat in Patients with Advanced Triple Negative Breast Cancer, with a Phase 1b Lead in Phase

What we are studying

Phase 1: The objective is to determine the dose-limiting toxicities and maximum tolerated dose of entinostat given in combination with atezolizumab, with the goal of defining the recommended dose to be used in the phase 2. Dose-limiting toxicity (DLT) is defined as a toxicity that would cause you to stop taking the medication at that dose level. Maximum tolerated dose (MTD) means to determine the highest dose of a study drug that can be given with acceptable side effects. All patients will be treated with atezolizumab, administered intravenously (it means through the vein) at the dose of 1200 mg at the day 1 of each cycle and entinostat given orally at the assigned dose on days 1, 8 and 15 of every cycle. Note : A cycle of treatment is defined as a 3 weeks period. The first 3 to 6 patients enrolled in the study will receive a dose of 5mg of entinostat. If 5mg of entinostat is not tolerated by more than 1 patient (i.e. > 2 patients with unacceptable side effects), then the next 3 to 6 patients will be treated at a dose of 3mg of entinostat. If 3mg of entinostat is not tolerated by more than 1 patient (> 2 patients), then the next 3 to 6 patients will be treated at a dose of 2mg of entinostat. All patients treated at one of these doses of entinostat are to complete their first cycle of treatment and be assessed for dose limiting toxicity before other patients may start participating in the study. If less than 33% of patients treated at a given dose of entinostat experience a dose limiting toxicity (i.e.. 0 or 1 patient among 6 treated),the recommended dose is established and the enrolment of the phase 2 may commence. If entinostat at 2mg is not tolerated, then the study will be stopped or additional doses or dosing schedules may be investigated and presented to the patients via a revised Patient Informed Consent Form. Phase 2: The objective is to compare the efficacy and safety of the combination of atezolizumab (administered intravenously every once cycle at the dose of 1200 mg) and entinostat (administered orally on days 1, 8 and 15 every cycle at the dose defined in phase 1) with the combination of atezolizumab (same regimen) and placebo (administered orally on days 1, 8 and 15).

Who is Eligible

  • Genders:
    • Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • Hispanic or Latino
  • Ages 18+

Eligibility Criteria

  • Has received at least 1
  • But no more than 2
  • Prior lines of systemic therapy for locally recurrent and/or metastatic disease

What is involved

  • Physical exams
  • Tumor biopsy
  • ECG
  • Blood draws
  • Questionnaires
  • CT scans

Compensation

None

Contact Information

Study Coordinator
Jasmine Miller
Email
jasmille@wakehealth.edu
Phone
336-713-5719
Principal Investigator
Dr. Alexandra Thomas

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.