A Dose-Escalation Study to Assess the Safety, Tolerability, and Pharmacokinetics of GDC-0032 in Combination With Docetaxel or With Paclitaxel in Patients With HER2-negative Locally Recurrent or Metastatic Breast Cancer

Status: Recruiting
Diagnosis: Breast: Metastatic
NCT ID: NCT01862081 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 13-123


This is an open-label, multicenter, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of GDC-0032 administered in combination with either docetaxel (Arm A) or with paclitaxel (Arm B) in patients with HER2-negative locally recurrent or metastatic breast cancer. Stage 1: Both Arms A and B will employ a dose-escalation design with escalating doses of GDC-0032. Once the maximum tolerated dose of GDC-0032 has been established, additional patients will be enrolled in the cohort-expansion stage (Stage 2).


Conducting Institutions:
Brigham and Women's Hospital, Dana-Farber Cancer Institute, Massachusetts General Hospital

Overall PI:
Ian Krop, MD, Dana-Farber Cancer Institute

Site-responsible Investigators:
Dejan Juric, MD, Massachusetts General Hospital

Dana-Farber Cancer Institute: Breast Cancer Nursing Team, 617-632-3478
Massachusetts General Hospital: Cancer Trials Call Center, 877-789-6100

Eligibility Criteria

Inclusion Criteria: - Adenocarcinoma of the breast with locally recurrent or metastatic disease - HER2-negative disease - Evaluable or measurable disease per RECIST v.1.1 - Life expectancy >= 12 weeks - Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 at screening - Adequate hematologic and end organ function Exclusion Criteria: - Known significant hypersensitivity to any components of study treatment - Grade >= 2 peripheral neuropathy - Grade >= 2 hypercholesterolemia or hypertriglyceridemia
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