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NCT Number: NCT03315364

Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy

To compare and evaluate the efficacy and safety of Liporaxel® solution (oral paclitaxel) and Taxol® (IV paclitaxel) on recurrent or metastatic breast cancer.

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This study is active but is not currently recruiting participants.

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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

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Oncology Complex Center - Burgas'' Ltd., Medical Oncology Department, Burgas, Bulgaria

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Who can participate

Healthy volunteers accepted: No

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

Key inclusion/exclusion criteria

  • Histologically or cytologically confirmed to have recurrent, or metastatic breast cancer.
  • Measurable disease (revised RECIST, version 1.1).
  • Hormone receptor (ER/PR) positive or negative, HER2 negative.
  • Subjects were eligible for the study regardless of their previous lines of endocrine therapy.
  • No prior chemotherapy is allowed in metastatic disease.
  • Subjects who administrated the last dose of taxane class drug ≥12months ago as from the first administration day.
  • ECOG performance status ≤1.
  • Neuropathy grade <2.
  • Subjects with central nervous system metastasis should be excluded.

Treatment and study plan

Oral Paclitaxel

Drug

Oral administration on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent

Other names: Liporaxel®

Paclitaxel Injection

Drug

Premedication, intravenous infusion on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent

Other names: Taxol®

Primary outcomes

  1. [Phase II] Objective Response Rate (ORR)

    Time frame: Participants will be followed every 6 weeks until progression, an expected average of 9 months.

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

  2. [Phase III] Progression Free Survival (PFS)

    Time frame: From date of randomization, assessed up to 18 months.

    Progression Free Survival (PFS) is defined as the time from date of randomization until the date of first documented progression or death

Secondary outcomes

  1. [Phase II] Progression Free Survival (PFS)

    Time frame: From date of randomization, assessed up to 18 months.

    Progression Free Survival (PFS) is defined as the time from date of randomization until the date of first documented progression or death

  2. [Phase III] Objective Response Rate (ORR)

    Time frame: Participants will be followed every 6 weeks until progression, an expected average of 9 months.

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

  3. [Phase II&III] Overall Survival(OS)

    Time frame: Until 6 months after the last participant is enrolled, assessed minimum to 18 months.

    Overall survival(OS) is defined as the time from the date of inclusion to the date of death, regardless of the cause of death.

  4. [Phase II&III] Time to Treatment Failure(TTF)

    Time frame: through study completion, an expected average of 4.5 year.

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

  5. [Phase II&III] Disease Control Rate(DCR)

    Time frame: through study completion, an expected average of 4.5 year.

    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 to End of treatment(EOT).

  6. [Phase II&III] Quality of life(QoL)

    Time frame: C1D1, C2D1, C4D1, C7D1, C10D1 (each cycle is 28 days) and study completion, up to 18 months.

    To evaluate changes versus baseline using the EQ-5D.

  7. Incidence of Treatment-Emergent Adverse Events [Safety]

    Time frame: Up to 28 days after last investigational product administraion.

    Number and Description of Adverse Events

Sponsors and collaborators

Lead sponsor

Daehwa Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

A Multinational, Multicenter, Open-label, Phase II/III Clinical Trial to Evaluate the Efficacy and Safety of Liporaxel® (Oral Paclitaxel) Compared to Taxol® (IV Paclitaxel) as First-line Therapy in Patients With Recurrent or Metastatic HER2 Negative Breast Cancer

Acronym: OPTIMAL

Important dates

Study start
2017
Primary completion
2024
Study completion
2028
First posted
Oct 20, 2017
Registry last updated
Apr 1, 2026

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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