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Anti-metabolites

DHP107 for Breast Cancer (OPERA Trial)

Phase 2
Waitlist Available
Led By John Ellerton, M.D.
Research Sponsored by Daehwa Pharmaceutical Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects with confirmed diagnosis of recurrent or metastatic breast cancer based on histopathology examination
Subjects with diagnosis of HER2-negative breast cancer that was confirmed by IHC or in situ hybridization (ISH) assessment of tumor samples
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks upto 18 months from randomization date
Awards & highlights

OPERA Trial Summary

This trial is testing a new oral form of paclitaxel to see if it works as well as the standard IV form to treat metastatic breast cancer.

Eligible Conditions
  • Breast Cancer

OPERA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

OPERA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks upto 18 months from randomization date
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks upto 18 months from randomization date for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate(ORR)
Secondary outcome measures
Disease control rate(DCR)
Duration of response(DOR)
Overall survival(OS)
+4 more

OPERA Trial Design

2Treatment groups
Experimental Treatment
Group I: IV paclitaxelExperimental Treatment1 Intervention
Total 24 subject will receive IV paclitaxel 80 mg/m2 weekly.(3 weeks on/1 week off)
Group II: DHP107Experimental Treatment1 Intervention
The 12 eligible subjects will receive DHP107 and be taken blood samples for PK analysis on Day 1, 8 of cycle 1. Total 48 subjects (including PK subjects) will receive DHP107 200 mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
FDA approved
Paclitaxel
FDA approved

Find a Location

Who is running the clinical trial?

Daehwa Pharmaceutical Co., Ltd.Lead Sponsor
6 Previous Clinical Trials
1,325 Total Patients Enrolled
John Ellerton, M.D.Principal InvestigatorNevada Cancer Research Foundation (NCRF)
Martin Smakal, M.D.Principal InvestigatorOnkologicky stacionar, NH Hospital a.s., nemocnice Horovice (NHH)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~11 spots leftby Mar 2025