Clinical trial NCT03315364: Oral Paclitaxel Trial In Recurrent and Metastatic Breast Cancer As 1st Line Therapy
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Recurrent or Metastatic Breast Cancer
Keywords: Recurrent breast cancer
Metastatic breast cancer
MBC
Firstline chemotherapy
Paclitaxel
Liporaxel
Taxol
Lead sponsor: Daehwa Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2017-10-20
Enrollment: 549
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1. Phase II clinical trial

   * Multicenter, Open-label, Single arm, Simon's optimal two-stage design
2. Phase III clinical trial

   * Multicenter, Prospective Randomized Open-label Blinded Endpoint (PROBE) design
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: [Phase II] Objective Response Rate (ORR)
timeFrame: Participants will be followed every 6 weeks until progression, an expected average of 9 months.
measure: [Phase III] Progression Free Survival (PFS)
timeFrame: From date of randomization, assessed up to 18 months.
Secondary outcomes:
measure: [Phase II] Progression Free Survival (PFS)
timeFrame: From date of randomization, assessed up to 18 months.
measure: [Phase III] Objective Response Rate (ORR)
timeFrame: Participants will be followed every 6 weeks until progression, an expected average of 9 months.
measure: [Phase II&III] Overall Survival(OS)
timeFrame: Until 6 months after the last participant is enrolled, assessed minimum to 18 months.
measure: [Phase II&III] Time to Treatment Failure(TTF)
timeFrame: through study completion, an expected average of 4.5 year.
measure: [Phase II&III] Disease Control Rate(DCR)
timeFrame: through study completion, an expected average of 4.5 year.
measure: [Phase II&III] Quality of life(QoL)
timeFrame: C1D1, C2D1, C4D1, C7D1, C10D1 (each cycle is 28 days) and study completion, up to 18 months.
measure: Incidence of Treatment-Emergent Adverse Events [Safety]
timeFrame: Up to 28 days after last investigational product administraion.
Other outcomes:
Locations:
city: Burgas
country: Bulgaria
facility: Oncology Complex Center - Burgas'' Ltd., Medical Oncology Department
city: Panagyurishte
country: Bulgaria
facility: Multi-profile Hospital for Active Treatment Uni Hospital Ltd. Medical Oncology Department
city: Sofia
country: Bulgaria
facility: Medical Center Nadezhda Clinical" Ltd.,
city: Hefei
country: China
facility: Anhui Cancer Hospital
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy Of Medical Sciences
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
city: Haikou
country: China
facility: The First Affiliated Hospital Of Hainan Medical College
state: Hainan
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
city: Zhengzhou
country: China
facility: Tianjin Cancer Hospital
state: Henan
city: Nanjing
country: China
facility: Jiangsu Cancer Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Province Hospital
state: Jiangsu
city: Changchun
country: China
facility: First Affiliated Hospital of Jilin University
state: Jilin
city: Shenyang
country: China
facility: Liaoning Cancer Hospital
state: Liaoning
city: Jinan
country: China
facility: Shangdong Cancer Hospital
state: Shandong
city: Linyi
country: China
facility: Linyi Cancer Hospital
state: Shandong
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong university
state: Shanxi
city: Chengdu
country: China
facility: West China School Of Medicine Sichuan University
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang University School Of Medicine Sir Run Run Shaw Hospital
state: Zhejiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital
city: Szekszárd
country: Hungary
facility: Tolna County Balassa János Hospital
city: Tatabánya
country: Hungary
facility: Szent Borbála Hospital
city: Cheongju-si
country: Korea, Republic of
facility: Chungbuk National University Hospital
state: Chungcheongbuk-do
city: Wŏnju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
state: Gangwon-do
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center
state: Gyeonggi-do
city: Seongnam
country: Korea, Republic of
facility: Cha University Cha Bundang Medical Center
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Medical Center
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Gangneung
country: Korea, Republic of
facility: Gang Neung Asan Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
city: Seoul
country: Korea, Republic of
facility: Catholic University of Korea Seoul ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Uijeongbu
country: Korea, Republic of
facility: Uijeongbu ST. Mary's Hospital
city: Belgrade
country: Serbia
facility: Institute for Oncology and Radiology of Serbia
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Bežanijska Kosa, Department of Oncology
city: Kladovo
country: Serbia
facility: Health Center Kladovo, Oncology Department
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac Center of Oncology and Radiotherapy
city: Kruševac
country: Serbia
facility: General Hospital Krusevac, Outpatient Clinic for chemotherapy
city: Niš
country: Serbia
facility: Clinical Center Niš, Clinic for Oncology
city: Sremska Kamenica
country: Serbia
facility: Oncology Institute of Vojvodina
Study officials:
affiliation: Asan Medical Center
name: Sung-bae Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim SB, Seo JH, Ahn JH, Kim TY, Kang SY, Sohn J, Yang Y, Park KH, Moon YW, Lim S, Kang MJ, Yoon KE, Cho HJ, Lee KS. Phase II study of DHP107 (oral paclitaxel) in the first-line treatment of HER2-negative recurrent or metastatic breast cancer (OPTIMAL study). Ther Adv Med Oncol. 2021 Dec 15;13:17588359211061989. doi: 10.1177/17588359211061989. eCollection 2021.