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Clinical Trial VICCBREP12116


An Open-Label, Phase I/IIa Study of ARN-810 in Postmenopausal 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
  • 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: Molecular Targeted Agents / Immunotherapy / Biologics
  • Drugs: ARN-810
  • Participating Institutions: Vanderbilt University
  • National Clinical Trial ID: NCT01823835
  • Secondary Protocol No: ARN-810-001 / 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.


Ages Eligible for Study:18 Years and older
Genders Eligible for Study:Female
Accepts Healthy Volunteers:No


Inclusion Criteria:
• Histologically or cytologically proven diagnosis of adenocarcinoma of the breast with evidence of either locally recurrent disease not amenable to resection or radiation therapy with curative intent, or metastatic disease, both progressing after at least 6 months of hormonal therapy for ER+ breast cancer
• ER-positive, HER2-negative
• At least 2 months must have elapsed from the use of tamoxifen
• At least 6 months must have elapsed from the use of fulvestrant
• At least 2 weeks must have elapsed from the use of any other anticancer hormonal therapy
• At least 3 weeks must have elapsed from the use of any chemotherapy
• Females, 18 years of age or older
• Postmenopausal status
• Eastern Cooperative Oncology Group (ECOG) performance status </= 2
• Adequate organ function
Phase II portion•all above inclusion criteria, plus:
Cohort A only: Confirmed ESR1 mutation and presence of measurable disease as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or evaluable bone disease
• Cohort A1 only: no prior fulvestrant allowed; at least 2 months must have elapsed from the use of tamoxifen
• Cohort A2 only: prior fulvestrant allowed Cohort B only: disease progression following no more than 1 prior treatment with an aromatase inhibitor in the advanced/metastatic setting
• Cohort B1 only: no prior fulvestrant allowed
• Cohort B2 only: prior fulvestrant allowed
Exclusion Criteria:
• Untreated or symptomatic CNS metastases
• Endometrial disorders
• More than 1 prior chemotherapy in the advanced/metastatic setting (prior adjuvant chemotherapy is allowed so long as it occurred >/= 12 months prior to enrollment)
• Current treatment with any systemic anticancer therapies for advanced disease or any systemic experimental treatment on another clinical trial
• Any significant cardiac dysfunction within 12 months prior to enrollment
• Active inflammatory bowel disease or chronic diarrhea, short bowel syndrome, or upper gastrointestinal surgery including gastric resection
• Known human immunodeficiency virus infection
• Major surgery within 4 weeks prior to enrollment
• Radiation therapy within 2 weeks prior to enrollment
Phase II portion•all above exclusion criteria, plus:
• Cohort A1, A2, and Cohort B2 only: > 1 prior chemotherapy in the advanced/metastatic setting
• Cohort B1 only: prior chemotherapy in the advanced/metastatic setting