Study of ARN-810 in Postmenopausal Women With Locally Advanced or Metastatic Estrogen Receptor Positive Breast Cancer

Status: Recruiting
Phase: Phase 1
Diagnosis: Breast: Metastatic
NCT ID: NCT01823835 (View complete trial on
DFCI Protocol ID: 13-043


Safety and pharmacokinetics (PK) study of ARN-810 in postmenopausal women with locally advanced or metastatic ER+ (HER2-) breast cancer.


Conducting Institutions:
Massachusetts General Hospital

Overall PI:
Aditya Bardia MD, MPH, Massachusetts General Hospital

Site-responsible Investigators:

Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Key Inclusion Criteria: 1. 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 2. ER-positive, HER2-negative 3. At least 2 months must have elapsed from the use of tamoxifen 4. At least 6 months must have elapsed from the use of fulvestrant 5. At least 2 weeks must have elapsed from the use of any other anti-cancer hormonal therapy 6. At least 4 weeks must have elapsed from the use of any chemotherapy 7. Females, 18 years of age or older 8. Postmenopausal status 9. Eastern Cooperative Oncology Group (ECOG) Performance status ≤ 2 Key Exclusion Criteria: 1. Untreated or symptomatic CNS metastases. 2. Endometrial disorders 3. 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) 4. Current treatment with any systemic anti-cancer therapies for advanced disease or any systemic experimental treatment on another clinical trial
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