Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
Hope Rugo, M.D. (ucsf)
Photo of Hope Rugo
Hope Rugo

Description

Summary

The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of DHP107 (Oral Paclitaxel, Korea brand name: Liporaxel®) compared to IV Paclitaxel in patients with Recurrent or Metastatic Breast Cancer.

Official Title

A Multi-center, Open-label, Phase 2 Clinical Trial to Evaluate the Efficacy, Safety and Pharmacokinetics of DHP107 (Liporaxel®, Oral Paclitaxel) Compared to IV Paclitaxel in Patients With Recurrent or Metastatic Breast Cancer(OPERA)

Keywords

Recurrent or Metastatic Breast Cancer Breast Cancer DHP107 Paclitaxel Liporaxel Breast Neoplasms Albumin-Bound Paclitaxel IV Paclitaxel

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Subjects with confirmed diagnosis of recurrent or metastatic breast cancer based on histopathology examination
  2. Subjects with diagnosis of HER2-negative breast cancer that was confirmed by IHC or in situ hybridization (ISH) assessment of tumor samples
  3. Subjects who have received up to 3 lines of therapy for advanced disease, without prior exposure to taxane in the advanced stage setting
  4. Subjects who have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.
  5. Subjects who have measurable disease according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1).

You CAN'T join if...

  1. Subjects who have received prior taxane therapy in the metastatic setting
  2. Subjects whose adjuvant or neoadjuvant treatment for early stage breast cancer was completed within 6 months prior to entry into the study.
  3. Subjects with neuropathy grade ≥2 based on CTCAE v4.03 at the time of study entry
  4. Subjects with symptomatic, untreated metastases to the central nervous system (CNS) at the time of screening.
  5. Subjects who have received any investigational drugs or devices within 4 weeks before the first day of study treatment (C1D1).

Locations

  • University of California San Francisco (UCSF) accepting new patients
    San Francisco California 94115 United States
  • California Research Institute (CRI) accepting new patients
    Los Angeles California 90027 United States

Lead Scientist at UC Cancer

  • Hope Rugo, M.D. (ucsf)
    Dr. Hope Rugo is a medical oncologist and hematologist specializing in breast cancer research and treatment. A Clinical Professor of Medicine, Dr. Rugo joined the Breast Care Center in 1999 after a decade of experience at UCSF in malignant hematology and bone marrow transplantation for a variety of diseases, including breast cancer.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Daehwa Pharmaceutical Co., Ltd.
ID
NCT03326102
Phase
Phase 2
Study Type
Interventional
Last Updated