Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DHP107 | Experimental | The 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. |
|
| IV paclitaxel | Experimental | Total 24 subject will receive IV paclitaxel 80 mg/m2 weekly.(3 weeks on/1 week off) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DHP107 | Drug | DHP107 200mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate(ORR) | ORR is defined by Response Evaluation Criteria in Solid Tumors (RECIST) (v.1.1) criteria | Every 8 weeks upto 18 months from randomization date |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival(PFS) | PFS is defined as the time from date of randomization until the date of first documented progression or death. | Up to 18 months from randomization date |
| Overall survival(OS) |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hope Rugo, M.D. | University of California, San Francisco | Principal Investigator |
| David Weng, M.D. | Anne Arundel Health System Research Institute (AAHS) | Principal Investigator |
| Neelima Vidula, M.D. | Massachusetts General Hospital (MGH) | Principal Investigator |
| Adam Brufsky, M.D. | University of Pittsburgh Medical Center (UPMC) | Principal Investigator |
| Timothy Pluard, M.D. | Saint Luke's Cancer Institute(SLCI) | Principal Investigator |
| Priyanka Sharma, M.D. | University of Kansas Medical Center(KUMC) | Principal Investigator |
| Jane Skelton, M.D. | Boca Raton Regional Hospital (BRRH) | Principal Investigator |
| Richard Caradonna, M.D. | ASCLEPES Research Center(ARC) | Principal Investigator |
| Yan Ji, M.D. | Metro-Minnesota Community Oncology Research Consortium (MMCORC) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| California Research Institute (CRI) | Los Angeles | California | 90027 | United States | ||
| University of California San Francisco (UCSF) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41910867 | Derived | 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. |
Not provided
Not provided
Not provided
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)
Not provided
Not provided
Not provided
Not provided
| IV Paclitaxel | Drug | IV Paclitaxel 80 mg/m2 QW (3 weeks on/1 week off) |
|
|
OS is defined as the time from the date of inclusion to the date of death.
| Up to 36 months from FPI |
| 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. | Up to 18 months from randomization date |
| Duration of response(DOR) | DOR is the time between the initial response to therapy and subsequent disease progression or relapse. | Up to 18 months from randomization date |
| 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. | Up to 18 months from randomization date |
| 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) | after randomization(C1D1), D1 of every 3rd cycle(each cycle consists of 28 days) up to 18 months |
| PK | Pharmacokinetics is defined as the study of the time course of drug absorption, distribution, metabolism, and excretion. | The 12 eligible subjects will receive DHP107 and be taken blood samples for PK analysis on Day 1, 8 of Cycle 1 |
| Craig Gordon, D.O. | Michigan Center of Medical Research(MCMR) | Principal Investigator |
| Ghassan Aljazayrly, M.D. | California Research Institute (CRI) | Principal Investigator |
| John Ellerton, M.D. | Nevada Cancer Research Foundation (NCRF) | Principal Investigator |
| Bohuslav Melichar, M.D. | Onkologicka klinika, Fakultni nemocnice Olomouc (OUH) | Principal Investigator |
| Martin Smakal, M.D. | Onkologicky stacionar, NH Hospital a.s., nemocnice Horovice (NHH) | Principal Investigator |
| Martina Zimovjanova, M.D. | Onkologicka klinika, Vseobecna fakultni nemocnice v Praze (VFN) | Principal Investigator |
| San Francisco |
| California |
| 94115 |
| United States |
| Boca Raton Regional Hospital (BRRH) | Boca Raton | Florida | 33486 | United States |
| ASCLEPES Research Center(ARC) | Weeki Wachee | Florida | 34607 | United States |
| Saint Luke's Cancer Institute(SLCI) | Kansas City | Kansas | 64111 | United States |
| University of Kansas Medical Center(KUMC) | Kansas City | Kansas | 66160 | United States |
| Anne Arundel Health System Research Institute (AAHS) | Annapolis | Maryland | 21401 | United States |
| Massachusetts General Hospital(MGH) | Boston | Massachusetts | 02114 | United States |
| Michigan Center of Medical Research(MCMR) | Farmington Hills | Michigan | 48334 | United States |
| Metro-Minnesota Community Oncology Research Consortium (MMCORC) | Minneapolis | Minnesota | 55426 | United States |
| Nevada Cancer Research Foundation (NCRF) | Las Vegas | Nevada | 89106 | United States |
| University of Pittsburgh Medical Center (UPMC) | Pittsburgh | Pennsylvania | 15232 | United States |
| Onkologicka klinika, Fakultni nemocnice Olomouc (OUH) | Olomouc | I.P. Pavlova 6 | 775 20 | Czechia |
| Onkologicky stacionar, NH Hospital a.s., nemocnice Horovice (NHH) | Hořovice | K Nemocnici | 1106268 31 | Czechia |
| Onkologicka klinika, Vseobecna fakultni nemocnice v Praze (VFN) | Prague | U Nemocnice 499/2 | 128 08 | Czechia |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 16, 2026 |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
Not provided
Not provided