UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006667 |
|---|---|
| Receipt number | 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 10:10:57 |
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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
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
Sponsor or person
Institute
Setouchi Breast Comprehensive Support Organaization
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007834
