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Completed

NCT Number: NCT03326102

Oral Paclitaxel Efficacy Safety and PK in Recurrent and Metastatic Breast Cancer

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.

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Key information

Conditions

Recurrent or Metastatic Breast Cancer Breast Diseases Breast Neoplasms Disease Attributes Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Onkologicka klinika, Fakultni nemocnice Olomouc (OUH), Olomouc, I.P. Pavlova 6, Czechia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • 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
  • Subjects who have received up to 3 lines of therapy for advanced disease, without prior exposure to taxane in the advanced stage setting
  • Subjects who have a performance status of ≤2 on the Eastern Cooperative Oncology Group (ECOG) scale.
  • Subjects who have measurable disease according to the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST version 1.1).

Key Exclusion Criteria:

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

Treatment and study plan

DHP107

Drug

DHP107 200mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days

Other names: Liporaxel®, Oral Paclitaxel

IV Paclitaxel

Drug

IV Paclitaxel 80 mg/m2 QW (3 weeks on/1 week off)

Other names: Taxol Injection

Primary outcomes

  1. Objective Response Rate(ORR)

    Time frame: Every 8 weeks upto 18 months from randomization date

    ORR is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria

Secondary outcomes

  1. Progression free survival(PFS)

    Time frame: Up to 18 months from randomization date

    PFS is defined as the time from date of randomization until the date of first documented progression or death.

  2. Overall survival(OS)

    Time frame: Up to 36 months from FPI

    OS is defined as the time from the date of inclusion to the date of death.

  3. Time to treatment failure(TTF)

    Time frame: Up to 18 months from randomization date

    TTF is defined as the time from the randomization date to the date of discontinuation of treatment, regardless of the cause.

  4. Duration of response(DOR)

    Time frame: Up to 18 months from randomization date

    DOR is the time between the initial response to therapy and subsequent disease progression or relapse.

  5. Disease control rate(DCR)

    Time frame: Up to 18 months from randomization date

    DCR is defined as the percentage of subjects who were evaluated for complete response(CR), partial response(PR), and stable disease(SD) as the best response among from randomization.

  6. Quality of life(QoL)

    Time frame: after randomization(C1D1), D1 of every 3rd cycle(each cycle consists of 28 days) up to 18 months

    Evaluate changes compared to baseline using European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

  7. PK

    Time frame: The 12 eligible subjects will receive DHP107 and be taken blood samples for PK analysis on Day 1, 8 of Cycle 1

    Pharmacokinetics is defined as the study of the time course of drug absorption, distribution, metabolism, and excretion.

Sponsors and collaborators

Lead sponsor

Daehwa Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multi-national,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)

Acronym: OPERA

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Oct 30, 2017
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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