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Could a pill replace IV chemo for breast cancer?

NCT ID NCT03315364

Disease control Sponsor: Daehwa Pharmaceutical Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares an oral version of the chemotherapy drug paclitaxel (Liporaxel) with the standard IV version (Taxol) in 549 people with recurrent or metastatic HER2-negative breast cancer. The goal is to see if the pill works as well or better at controlling the disease and is safe. Participants take either the oral or IV drug on days 1, 8, and 15 of a 4-week cycle.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Oral paclitaxel (Liporaxel)
What this could lead to
If it works, this could offer a more convenient, pill-based chemotherapy option for people with advanced breast cancer, potentially reducing hospital visits.
What could go wrong
This is a mid-stage trial, so results are not yet proven. Oral paclitaxel may not work as well as the IV version, and side effects could differ or be worse.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2/3

Runs two stages together: whether the treatment works, then large-scale confirmation.

Participants

549 people

The number who actually took part.

Started

Dec 2017

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Her2-receptor negative breast cancer Recurrence

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Recurrent or metastatic breast cancer

Contacts and locations

Locations

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499, South Korea

  • Anhui Cancer Hospital

    Hefei, Anhui, China

  • Asan Medical Center

    Seoul, 05505, South Korea

  • Cancer Hospital Chinese Academy Of Medical Sciences

    Beijing, Beijing Municipality, China

  • Catholic University of Korea Seoul ST. Mary's Hospital

    Seoul, South Korea

  • Cha University Cha Bundang Medical Center

    Seongnam-si, Gyeonggi-do, 13496, South Korea

  • Chungbuk National University Hospital

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Clinical Center Kragujevac Center of Oncology and Radiotherapy

    Kragujevac, 34000, Serbia

  • Clinical Center Niš, Clinic for Oncology

    Niš, 18000, Serbia

  • Clinical Hospital Center Bežanijska Kosa, Department of Oncology

    Belgrade, 11080, Serbia

  • First Affiliated Hospital of Jilin University

    Changchun, Jilin, China

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, China

  • Gachon University Gil Medical Center

    Incheon, South Korea

  • Gang Neung Asan Hospital

    Gangneung, South Korea

  • Gangnam Severance Hospital

    Seoul, South Korea

  • General Hospital Krusevac, Outpatient Clinic for chemotherapy

    Kruševac, 37000, Serbia

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, China

  • Health Center Kladovo, Oncology Department

    Kladovo, 19320, Serbia

  • Henan Cancer Hospital

    Zhengzhou, China

  • Inje University Haeundae Paik Hospital

    Busan, 612-896, South Korea

  • Institute for Oncology and Radiology of Serbia

    Belgrade, 11000, Serbia

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, China

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, China

  • Keimyung University Dongsan Medical Center

    Daegu, South Korea

  • Konyang University Hospital

    Daejeon, 35365, South Korea

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • Korea University Guro Hospital

    Seoul, 08308, South Korea

  • Kosin University Gospel Hospital

    Busan, South Korea

  • Liaoning Cancer Hospital

    Shenyang, Liaoning, China

  • Linyi Cancer Hospital

    Linyi, Shandong, China

  • Medical Center Nadezhda Clinical" Ltd.,

    Sofia, 1330, Bulgaria

  • Multi-profile Hospital for Active Treatment Uni Hospital Ltd. Medical Oncology Department

    Panagyurishte, 4500, Bulgaria

  • National Cancer Center

    Goyang-si, Gyeonggi-do, 10408, South Korea

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

    Burgas, 8000, Bulgaria

  • Oncology Institute of Vojvodina

    Kamenitz, 21204, Serbia

  • Pusan National University Yangsan Hospital

    Busan, South Korea

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seoul National University Hospital

    Seoul, 03080, South Korea

  • Shangdong Cancer Hospital

    Jinan, Shandong, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, China

  • Szent Borbála Hospital

    Tatabánya, 2800, Hungary

  • The First Affiliated Hospital Of Hainan Medical College

    Haikou, Hainan, China

  • The First Affiliated Hospital of Xi'an Jiaotong university

    Xi’an, Shanxi, China

  • Tianjin Cancer Hospital

    Zhengzhou, Henan, China

  • Tolna County Balassa János Hospital

    Szekszárd, 7100, Hungary

  • Uijeongbu ST. Mary's Hospital

    Uijeongbu-si, South Korea

  • West China School Of Medicine Sichuan University

    Chengdu, Sichuan, China

  • Wonju Severance Christian Hospital

    Wŏnju, Gangwon-do, 220-701, South Korea

  • Yonsei University Severance Hospital

    Seoul, 03722, South Korea

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, China

  • Zhejiang University School Of Medicine Sir Run Run Shaw Hospital

    Hangzhou, Zhejiang, China

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