UMIN-CTR Clinical Trial

Basic information
Public title	Study of combination chemotherapy of CPT-11/S-1 after anthracycline and taxane in recurrent or metastatic breast cancer (JBCRG-M01)
Acronym	Study of combination chemotherapy of CPT-11/S-1 after anthracycline and taxane in recurrent or metastatic breast cancer (JBCRG-M01)
Scientific Title	Study of combination chemotherapy of CPT-11/S-1 after anthracycline and taxane in recurrent or metastatic breast cancer (JBCRG-M01)
Scientific Title:Acronym	Study of combination chemotherapy of CPT-11/S-1 after anthracycline and taxane in recurrent or metastatic breast cancer (JBCRG-M01)
Region	Japan

Condition
Condition	Reccurent or metastatic breast cancer
Classification by specialty	Hematology and clinical oncology Breast surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the safety and efficacy of a combination chemotherapy with CPT-11 and S-1 in recurrent or metastatic breast cancer patients with prior chemotherapy with anthracycline and taxane
Basic objectives2	Others
Basic objectives -Others	To investigate the relationship between adverse effects and efficacy and UGT1A1 polymorophism
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Phase I,II

Assessment
Primary outcomes	Phase I:MTD, DLT, RD Phase II:Clinical response, Clinical efficacy
Key secondary outcomes	Phase II:Adverse events, TTP, OS

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Chemotherapy
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	Reccurent, metastatic breast cancer Previous anthracycline, taxane Her 2 negative PS 0-2 Adequate organ function Informed consent
Key exclusion criteria	Prior chemotherapy with CPT-11, S-1 Diarrhea No lesion other than bone metastasis Brain metastasis Serious cardiac disease
Target sample size	49

Research contact person
Name of lead principal investigator	1st name Masakazu Middle name Last name Toi
Organization	Graduate School of Medicine Kyoto University
Division name	Department of Surgery (Breast Surgery)
Zip code	606-8507
Address	54 Kawara-cho Shogoin, Sakyo-ku, Kyoto, 606-8507 Japan
TEL	075-751-3660
Email	toi@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Katsumasa Middle name Last name Kuroi
Organization	Japan Breast Cancer Research Group (JBCRG)
Division name	Head office
Zip code	103-0016
Address	9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
TEL	03-6264-8873
Homepage URL	https://jbcrg.jp/
Email	office@jbcrg.jp

Sponsor
Institute	Japan Breast Cancer Research Group (JBCRG)
Institute
Department

Funding Source
Organization	ACRO
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	JBCRG
Address	9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
Tel	03-6264-8873
Email	office@jbcrg.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	東京都立駒込病院(東京都)、京都大学医学部附属病院（京都府）、愛知県がんセンター中央病院（愛知県）、埼玉医大国際医療センター（埼玉県）

Other administrative information
Date of disclosure of the study information	2006 Year 11 Month 09 Day

Related information
URL releasing protocol	https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results	Partially published

Result
URL related to results and publications	NA
Number of participants that the trial has enrolled	12
Results	DLT was grade 4 hematological toxicity and grade 3>= nonhematological toxicities. Recommended dose for phase II were CPT-11 100mg/m2, TS-1 80-120mg/day.
Results date posted	2021 Year 08 Month 17 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2009 Year 07 Month 03 Day
Baseline Characteristics	Recurrent or metastatic HER2-negative breast cancer previously treated with anthracyclines and taxanes.
Participant flow	12 patients were enrolled in this Phase 1 study (metastatic 4, recurrence 8).
Adverse events	Diarrhea, alopecia, neutropenia were common adverse events.
Outcome measures	maximum tolerated dose (MTD), dose-limiting toxicities (DLTs), recommended dose (RD).
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 06 Month 23 Day
Date of IRB	2006 Year 07 Month 10 Day
Anticipated trial start date	2006 Year 11 Month 01 Day
Last follow-up date	2011 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Presentation: 17th Annual Meeting of the Japanese Breast Cancer Society(2009)

Management information
Registered date	2006 Year 11 Month 09 Day
Last modified on	2021 Year 08 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000626