UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002447 |
|---|---|
| Receipt number | R000002993 |
| Scientific Title | Study of neoadjuvant Letrozole combined with standerd chemotherapy for postmenopausal women with Endocrine-responsive Breast Cancer(subject of stage2,3A) |
| Date of disclosure of the study information | 2009/09/04 |
| Last modified on | 2012/09/04 10:10:22 |
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Basic information
Public title
Study of neoadjuvant Letrozole combined with standerd chemotherapy for postmenopausal women with Endocrine-responsive Breast Cancer(subject of stage2,3A)
Acronym
Niigata Breast Cancer Trial-02
Scientific Title
Study of neoadjuvant Letrozole combined with standerd chemotherapy for postmenopausal women with Endocrine-responsive Breast Cancer(subject of stage2,3A)
Scientific Title:Acronym
Niigata Breast Cancer Trial-02
Region
| Japan |
Condition
Condition
Postmenopausal, hormone-receptor positive and resectable primary breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the pathological response for neoadjuvant letorozole combined with anthracycline followed by taxane in postmenopausal women with hormone receptor positive Stage II or IIIA breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological response
Key secondary outcomes
Clinical response rate,Breast Conserving Surgery rate,Safety
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
Epirubicin 90-100 mg/m2, Cyclophosphamide 600 mg/m2, q3w x 4 cycles or Adriamycin 60 mg/m2, Cyclophosphamide 600 mg/m2, q3w x 4 cycles + Paclitaxel 80 mg/m2, weekly 12cycles and Letrozole 2.5mg p.o. daily for 24weeks over
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
| 60 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Female
Key inclusion criteria
1.Operable primary breast cancer(Stage2 ,3A at first diagnosis)
2.Postmenopausal patients who satisfies one or more below criteria;
A,Prior bilateral oophorectomy
B,>=60 years old < 70 years old
C,< 60 years old and amenorrheic for 12 months or more and FSH , plasma estradiol level in postmenopausal ranges
D,< 60 years old and after hysterectomy and FSH , plasma estradiol level in postmenopausal ranges
3.Measurable region
4.ER and/or PgR positive
5.PS 0-1(ECOG)
6.Adequate major organ function;
WBC >= 3,000/mm3, <= 12,000/mm3 or ANC >= 2,000/mm3
PLT >= 100,000/mm3
Hb >= 9.5 g/dl
GOT,GPT <=1.5 x ULN
Total bilirubin <= 1.25 x ULN
Serum creatinin <= 1.5
Cardiac function normal ECG
7.Patient judged appropriate for this study by the physicians
8.Written informed consent
Key exclusion criteria
1.Serious complications ( e.g malignant hypertension, CHF, hepatic failure, MI within 6 months, PE, arrhythmia treatment needed, infection, hemorrhagic tendency )
2.Hepatitis B
3.Serious Diabetes mellitus
4.Infection disease
5.Active multiple cancer
6.Edema
7.Inflammatory breast cancer
8.Synchronous bilateral breast cancer
9.History of drug-hypersensitivity
10.Patients have been treated with steroid or hormone replacement therapy or raloxifene
11.Mental disease
12.Osteoporosis, treated with bisphosphonate at present
13.Patient judged inappropriate for this study by the physicians
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Chizuko Kanbayashi |
Organization
Niigata Cancer Center Hospital
Division name
Department of Surgery
Zip code
Address
2-15-3, Kawagishi-cho, Chuo-ku, Niigata-City 951-8566, Niigata Prefecture
TEL
025-266-5111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Niigata Cancer Center Hospital
Division name
Department of Surgery
Zip code
Address
2-15-3, Kawagishi-cho, Chuo-ku, Niigata-City 951-8566, Niigata Prefecture
TEL
025-266-5111
Homepage URL
Sponsor or person
Institute
Niigata Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
| 2009 | Year | 09 | 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
Suspended
Date of protocol fixation
| 2009 | Year | 05 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 04 | Day |
Last modified on
| 2012 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002993
