UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062648 |
|---|---|
| Receipt number | R000071333 |
| Scientific Title | Phase I/II study evaluating the safety, tolerability, and efficacy of sacituzumab govitecan administered on day 1 and day 8 in combination with pegfilgrastim on day 2 in patients with unresectable or recurrent HER2-negative breast cancer |
| Date of disclosure of the study information | 2026/08/21 |
| Last modified on | 2026/08/21 16:48:37 |
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Basic information
Public title
Phase I/II study evaluating the safety, tolerability, and efficacy of sacituzumab govitecan in combination with pegfilgrastim in patients with HER2-negative breast cancer
Acronym
OMO-01
Scientific Title
Phase I/II study evaluating the safety, tolerability, and efficacy of sacituzumab govitecan administered on day 1 and day 8 in combination with pegfilgrastim on day 2 in patients with unresectable or recurrent HER2-negative breast cancer
Scientific Title:Acronym
SG concurrent Pegfilgrastim for Breast Cancer
Region
| Japan |
Condition
Condition
Unresectable or recurrent HER2-negative breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this clinical trial is to evaluate whether subcutaneous injection of pegfilgrastim, a long-acting G-CSF formulation, on day 2 of the treatment cycle can prevent neutropenia and allow safe and on-schedule intravenous infusion of sacituzumab govitecan on day 8. In addition, a preliminary analysis of the relationship between Trop-2 expression and clinical outcomes will be explored.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase I,II
Assessment
Primary outcomes
Phase I Safety and tolerability of sacituzumab govitecan with concurrent administration of pegfilgrastim (e.g., incidence of adverse events)
Phase II Efficacy of sacituzumab govitecan with concurrent administration of pegfilgrastim based on RECIST objective response rate
Key secondary outcomes
Progression-free survival (PFS)
Dose intensity (DI) for two cycles of sacituzumab govitecan administration
(Exploratory) Relationship between Trop-2 expression and clinical outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
In a 21-day cycle, sacituzumab govitecan (Trodelvy) 10 mg/kg will be administered intravenously on day 1 and day 8, and pegfilgrastim (preceding product "G-Lasta" or generic drug "Pegfilgrastim BS subcutaneous injection 3.6 mg") will be administered subcutaneously on day 2.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese male or female patients aged 20 years or older who can understand the study contents and provide written informed consent.
Patients with locally advanced, inoperable, or metastatic TNBC (triple-negative breast cancer) or hormone receptor-positive and HER2-negative breast cancer who have received previous chemotherapy for locally advanced, inoperable, or metastatic disease.
Key exclusion criteria
Patients harboring both homozygotes for UGT1A1*6 and heterozygotes for UGT1A1*6 and UGT1A1*28, as well as homozygosity for UGT1A1*28.
Patients with active infections.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kaneaki |
| Middle name | |
| Last name | Inoue |
Organization
Rakuwakai Otowa Hospital
Division name
Department of Medical Oncology
Zip code
607-8062
Address
2 Otowachinji-cho, Yamashina-ku, Kyoto, Japan
TEL
+81-75-593-4111
inoue-kaneaki@rakuwa.or.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Matsuoka |
Organization
Rakuwakai Healthcare System
Division name
Academic Support Center
Zip code
607-8062
Address
2 Otowachinji-cho, Yamashina-ku, Kyoto, Japan
TEL
+81-75-593-0417
Homepage URL
matsuoka-aya@rakuwa.or.jp
Sponsor or person
Institute
Rakuwakai Otowa Hospital
Institute
Department
Personal name
Funding Source
Organization
Self-funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of the Rakuwakai Otowa Hospital
Address
2 Otowachinji-cho, Yamashina-ku, Kyoto 607-8062, Japan
Tel
075-593-0417
matsuoka-aya@rakuwa.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 08 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2032 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 08 | Month | 21 | Day |
Last modified on
| 2026 | Year | 08 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071333
