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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000002447
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Niigata Cancer Center Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002993

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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