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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000006667
Receipt No. R000007834
Scientific Title Phase II study of efficacy of letrozole in postmenopausal patients with endocrine-responsive, HER2-negative metastatic breast cancer resistant to exemestane or anastrozole.
Date of disclosure of the study information 2011/11/04
Last modified on 2011/11/04

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Basic information
Public title Phase II study of efficacy of letrozole in postmenopausal patients with endocrine-responsive, HER2-negative metastatic breast cancer resistant to exemestane or anastrozole.
Acronym SBP-02
Scientific Title Phase II study of efficacy of letrozole in postmenopausal patients with endocrine-responsive, HER2-negative metastatic breast cancer resistant to exemestane or anastrozole.
Scientific Title:Acronym SBP-02
Region
Japan

Condition
Condition Metastatic breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Examine the efficacy of therapy with letrozole for endocrine-responsive, HER2-negative metastatic breast cancer patients in postmenopausal women with tumor which has relapsed or progressed during treatment or after within 1 year by exemestane or anastrozole.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Clinical benefit rate
Key secondary outcomes Response rate, Time to progression, Overall survival, Safety

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 EL: Letrozole(2.5 mg Tablet) is administered orally once a day for endocrine-responsive, HER2-negative metastatic breast cancer patients in postmenopausal women with tumor which has relapsed or progressed during treatment or after within 1 year by exemestane.
Interventions/Control_2 AL: Letrozole(2.5 mg Tablet) is administered orally once a day for endocrine-responsive, HER2-negative metastatic breast cancer patients in postmenopausal women with tumor which has relapsed or progressed during treatment or after within 1 year by anastrozole.
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

Not applicable
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1. Patients who provided written informed consent by themselves in principle to participate in this trial.
2. Patients with a performance status (ECOG) of 2-0.
3. Patients who confirmed to be Amenorrhea past 1 year.
4. Patients whom the primary or metastatic lesion was confirmed to be breast cancer by histological examination.
5. Patients whom the primary or metastatic lesion was confirmed to be ER-positive and HER2-negative.Except for IHC 2+/not tested FISH
6. Patients with measurable metastatic by RECIST ver1.1
7. Patients who showed recurrence during or after treatment within 1 year of exemestane or anastrozole.
8. Patients with no history of treatment by letrozole.EL: Patients with no history of treatment by anastrozole.(AL: Does not matter for history of treatment by exemestane.)
9. Patients expected to survive for 3 months or more.
10. Patients who satisfies the following organ function.
(Using the latest Laboratory parameters within 30 days prior to enrollment.)
WBC: >= 2,000/mm3 or Neu: >= 1,000/mm3
Hb: >= 9.0g/dL
Plt: >= 100,000/mm3
T-Bil: <= 2 times ULN(upper limit of normal)
AST and ALT: <= 2 times ULN
Creatinin: <= 2 times ULN
Key exclusion criteria 1. Patients with active other malignancies.(other simultaneity malignancies and other heterochrony malignancies within 5 years disease-free interval)
*Except patients who cured carcinoma in situ or intramucosal carcinoma by local treatment.
2. Patients with brain metastasis with symptom.
3. Patients who confirmed to be unstable angina pectoris, congestive heart failure, myocardial infarction, myocardial infarction, ventricular arrhythmia that need treat within 6 months before register.
4. Patients who confirmed to be uncontrollable hypertension, diabetes when you register.
5. Patients with severe infectious disease.
6. Patients with severe complications
7. Patients who are receiving bisphosphonates for hypercalcemia by malignancy.(Except patients who had receiving bisphosphonates for osteoporosis, bone metastases.)
8. Other patients who were considered by the primary care physician to be inappropriate as subjects of this trial.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiko Ikeda
Organization Fukuyama City Hospital
Division name Department of Breast and Thyroid Surgery
Zip code
Address 5-23-1 Zao-Cho, Fukuyama-City, Hiroshima, Japan, 721-8511
TEL 084-941-5151
Email

Public contact
Name of contact person
1st name
Middle name
Last name Tadahiko Shien
Organization Setouchi Breast Project Comprehensive Organization
Division name Clinical Research Group
Zip code
Address 2-5-1 Shikata Kita-ku Okayama Okayama Japan, 700-8558
TEL 086-235-7265
Homepage URL
Email

Sponsor
Institute Setouchi Breast Comprehensive Support Organaization
Institute
Department

Funding Source
Organization Setouchi Breast Comprehensive Support Organaization
Organization
Division
Category of Funding Organization Non profit foundation
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 11 Month 04 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 Open public recruiting
Date of protocol fixation
2011 Year 10 Month 26 Day
Date of IRB
Anticipated trial start date
2011 Year 11 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 11 Month 04 Day
Last modified on
2011 Year 11 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007834

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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