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Recurrent or Metastatic Breast CancerPhase 2OPERANCT03326102

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

A Phase 2 study testing DHP107 and IV Paclitaxel in people with Recurrent or Metastatic Breast Cancer, run by Daehwa Pharmaceutical Co., Ltd. at 15 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Recurrent or Metastatic Breast Cancer
What is being tested?
DHP107 and IV Paclitaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
72 participants
Where
15 sitesin 2 countries
Study dates
6 Jul 2018to 13 Dec 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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).

Trial locations and contacts

15 sites in 2 countries.

15 sites in 2 countries

United States12 sites

  • Anne Arundel Health System Research Institute (AAHS)

    Annapolis, Maryland, 21401

  • Boca Raton Regional Hospital (BRRH)

    Boca Raton, Florida, 33486

  • Massachusetts General Hospital(MGH)

    Boston, Massachusetts, 02114

  • Michigan Center of Medical Research(MCMR)

    Farmington Hills, Michigan, 48334

  • Saint Luke's Cancer Institute(SLCI)

    Kansas City, Kansas, 64111

  • University of Kansas Medical Center(KUMC)

    Kansas City, Kansas, 66160

  • Nevada Cancer Research Foundation (NCRF)

    Las Vegas, Nevada, 89106

  • California Research Institute (CRI)

    Los Angeles, California, 90027

  • Metro-Minnesota Community Oncology Research Consortium (MMCORC)

    Minneapolis, Minnesota, 55426

  • University of Pittsburgh Medical Center (UPMC)

    Pittsburgh, Pennsylvania, 15232

  • University of California San Francisco (UCSF)

    San Francisco, California, 94115

  • ASCLEPES Research Center(ARC)

    Weeki Wachee, Florida, 34607

Other trials in United States

Czechia3 sites

  • Onkologicky stacionar, NH Hospital a.s., nemocnice Horovice (NHH)

    Hořovice, K Nemocnici, 1106268 31

  • Onkologicka klinika, Fakultni nemocnice Olomouc (OUH)

    Olomouc, I.P. Pavlova 6, 775 20

  • Onkologicka klinika, Vseobecna fakultni nemocnice v Praze (VFN)

    Prague, U Nemocnice 499/2, 128 08

Other trials in Czechia

About this study

Official 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)

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.

Being tested
DHP107, IV Paclitaxel
Keywords
Breast Cancer, DHP107, Paclitaxel, Liporaxel
Medical subject headings
Recurrence, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DHP107Drug

    Also called Liporaxel®, Oral Paclitaxel

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

  • IV PaclitaxelDrug

    Also called Taxol Injection

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

Study groups in NCT03326102
Study groupRoleWhat they receive
DHP107ExperimentalThe 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.
Receives: Drug: DHP107
IV paclitaxelExperimentalTotal 24 subject will receive IV paclitaxel 80 mg/m2 weekly.(3 weeks on/1 week off)
Receives: Drug: IV Paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate(ORR)

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

    Measured: Every 8 weeks upto 18 months from randomization date

Secondary outcomes (7)

  1. Progression free survival(PFS)

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

    Measured: Up to 18 months from randomization date

  2. Overall survival(OS)

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

    Measured: Up to 36 months from FPI

  3. Time to treatment failure(TTF)

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

    Measured: Up to 18 months from randomization date

  4. Duration of response(DOR)

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

    Measured: Up to 18 months from randomization date

  5. Disease control rate(DCR)

    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.

    Measured: Up to 18 months from randomization date

  6. Quality of life(QoL)

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

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

  7. PK

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Oct 2017
  2. Study start6 Jul 2018
  3. Primary completion13 Dec 2022
  4. Study completion13 Dec 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subjects will be assigned to DHP107 or IV paclitaxel in a ratio of 2:1 (n=48 to DHP107 and n=24 to IV paclitaxel)
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03326102
Sponsor's protocol ID
107CS-6
Acronym
OPERA
Status last verified
Jan 2022
First submitted
19 Oct 2017
Last updated
16 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Rugo HS, Pluard TJ, Sharma P, Melisko M, Al-Jazayrly G, Ji Y, Vidula N, Ellerton J, Smakal M, Zimovjanova M, Weng D. OPERA: a phase II study of DHP107 (oral paclitaxel) versus intravenous paclitaxel in patients with HER2-negative recurrent or metastatic breast cancer. Breast Cancer Res Treat. 2026 Mar 30;217(1):5. doi: 10.1007/s10549-026-07944-2.

    PubMed 41910867

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing DHP107 and IV Paclitaxel in people with Recurrent or Metastatic Breast Cancer, run by Daehwa Pharmaceutical Co., Ltd. at 15 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States, Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate(ORR) (time frame: Every 8 weeks upto 18 months from randomization date). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03326102, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2024.

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