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Clinical Trial VICCBREP12116


An Open-Label, Phase IA/IB/IIA Study of GDC-810 Single Agent or in Combination With Palbociclib and/or an LHRH Agonist in Women with Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer

Principal Investigator(s)

Ingrid Mayer


  • Protocol No. VICCBREP12116
  • Open Date: 03/25/2013
  • Staging: Phase I/II
  • Age Group: Adults
  • Scope: National
  • Objective: To determine the maximum tolerated dose (MTD) and/or recommended Phase II dose (RP2D) and assess the safety of ARN-810 in postmenopausal women with locally advanced or metastatic ER+ (HER2-) breast cancer
  • Disease Sites: Breast
  • Therapies: Hormonal Therapy; Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: ARN-810; GDC-0810; Palbociclib (PD 0332991)
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01823835
  • Secondary Protocol No: GO29642


The participants are being asked to take part in this study because the participants know or their doctor has confirmed that they are postmenopausal (they have stopped having their menstrual period) and have locally advanced or metastatic (type of breast cancer that has spread to other parts of your body) estrogen receptor (ER) positive breast cancer which has come back or gotten worse after treatment with hormonal therapy. ARN-810 (also referred to in this form as the study drug) is an investigational new drug designed to block the female sex hormones which contribute to cancer progression. This will be the first time ARN-810 will be given to humans. The purpose of the study is to evaluate the safety (side effects) and look for any anti-cancer activity of ARN-810 in postmenopausal women with advanced breast cancer. The safety of ARN-810 will be tested at different dose levels, after one dose, and after many doses. This study wants to find out what effects, good and/or bad, ARN-810 has on you and your breast cancer. The study will also test for the amount of ARN-810 in the participants- blood and in the tumor.


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