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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000005881
Receipt No. R000006944
Scientific Title Phase II study of gemcitabine and trastuzumab in patients with metastatic breast cancer
Date of disclosure of the study information 2011/07/01
Last modified on 2016/01/04

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Basic information
Public title Phase II study of gemcitabine and trastuzumab in patients with metastatic breast cancer
Acronym SBP-01
Scientific Title Phase II study of gemcitabine and trastuzumab in patients with metastatic breast cancer
Scientific Title:Acronym SBP-01
Region
Japan

Condition
Condition Metastatic breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficacy and safety of gemcitabine plus trastuzumab in chemotherapy and trastuzumab-pretreated patients with metastatic breast cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes Objective response rate
Key secondary outcomes Progression free survival, Overall survival, Adverse events rate

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -but assessor(s) are 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 Combination treatment of gemcitabine and trastuzumab
gemcitabine 1250mg/m2 day1,8 21days cycle
trastuzumab 2mg/kg (Initial dose 4mg/kg) q1w
continuing treatment until disease progression
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 Female
Key inclusion criteria 1) Signed written informed consent
2) Age over 20 years.
3) ECOG performance Status 0-2
4) Histologically confirmed adenocarcinoma of the breast
5) HER2-positive in the tissue of primary breast cancer or metastatic sites.
6) Patients must have measurable disease that is evaluable according to RECIST 1.1
7) LVEF over 50% at baseline
8) Adequate organ function
9) Prior combination treatment with trastuzumab and chemotherapy
10) Expectation of more than 3 months survival
Key exclusion criteria 1) Active double cancer
2) Brain metastases that requiring treatment at registration
3) Unstable angina pectoris, congestive heart failure, myocardial infarction, or ventricular arrhythmia requiring medication within 6 months to registration
4) Uncontrolled hypertension or diabetes mellitus.
5) Active infection disease
6) Other severe, uncontrolled systemic disease
7) Over grade 3 hypersensitivity reaction to trastuzumab
8) Hormonal therapy, chemotherapy, or biological treatment <7days prior to registration
9) Radiation therapy <14days prior to registration
10) Prior gemcitabine therapy
11) Current pregnancy and lactation
12) Assessment by the investigator to be unsuitable to comply with the requirements of the protocol

Target sample size 42

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fumikata Hara
Organization National Hospital Organization Shikoku Cancer Center
Division name Department of medical oncology
Zip code
Address 160 Minami Umemoto Ko, Matsuyama, Ehime, Japan 7910280
TEL 089-999-1111
Email hfumikat@shikoku-cc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Naruto Taira
Organization Setouchi Breast Project Comprehensive Organization
Division name Clinical Research Group
Zip code
Address 2-5-1 Shikata Kita-ku Okayama Okayama Japan, 7008558
TEL 086-235-7265
Homepage URL
Email info@setouchi-bp.com

Sponsor
Institute Setouchi Breast Project Comprehensive Organization
Institute
Department

Funding Source
Organization Setouchi Breast Project Comprehensive Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2011 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Background:  There are few evidence on efficacy of Tmab-containing regimens after disease progression. Gemcitabine (GEM) is non-cross resistant to anthracycline and taxane. Preclinical studies have shown that the combination of Tmab and GEM has synergistic effect against HER2-positive breast cancer cell lines. SBP-01 study assessed the efficacy and safety of the combination of Tamb and GEM in patients with HER2-positive MBC previously treated with anti-HER2 therapy. Methods:  SBP-01 study included patients treated with one or more anti-HER2 directed regimens for MBC. Patients were administered with GEM 1250 mg/m2 on days 1 and 8 of each 21-day cycle and Tmab 4mg/kg loading dose and then 2mg/kg weekly. The primary endpoint was objective response rate (ORR). Secondary endpoints included progression free survival (PFS), overall survival, and safety. Results:  Between June 2011 and June 2014, 35 patients were enrolled. Patients had ER positive tumor (37.1%), a median of 2 metastatic organ sites, visceral metastasis (80.0%), prior (neo) adjuvant Tmab (22.9%) and a median of 2 prior chemotherapy regimens for MBC. Previous HER2-directed drugs included Tmab (94.3%), lapatinib (37.1%), T-DM1 (8.6%) and pertuzumab (2.9%). ORR was 22.9% (95% CI, 8.6%-36.8%). Median PFS was 146 days. Patients with stable disease response received a median of 7 cycles (6-28 cycles) of treatment. Grade3/4 leukopenia (20.0%) and neutropenia (48.6%) were observed. All non-hematological toxicities were less than grade3. Conclusions: The Combination Tmab and GEM is effective and well-tolerated regimen for patients previously treated with HER2-directed therapy, and appears to make disease stable for long time period. 
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 Main results already published
Date of protocol fixation
2011 Year 06 Month 16 Day
Date of IRB
Anticipated trial start date
2011 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 06 Month 29 Day
Last modified on
2016 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006944

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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