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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001331
Receipt No. R000001613
Scientific Title Phase II study of neoadjuvant Letrozole combined with low dose metronomic Cyclophosphamide for postmenopausal women with Endocrine-responsive Breast Cancer (JBCRG-07)
Date of disclosure of the study information 2008/08/22
Last modified on 2019/11/21

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Basic information
Public title Phase II study of neoadjuvant Letrozole combined with low dose metronomic Cyclophosphamide for postmenopausal women with Endocrine-responsive Breast Cancer (JBCRG-07)
Acronym JBCRG-07
Scientific Title Phase II study of neoadjuvant Letrozole combined with low dose metronomic Cyclophosphamide for postmenopausal women with Endocrine-responsive Breast Cancer (JBCRG-07)
Scientific Title:Acronym JBCRG-07
Region
Japan

Condition
Condition Postmenopausal, hormone-receptor positive and primary breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Evaluation of the response rate and the pathological response for primary site or measurable involved lymph nodes, and the safety of neoadjuvant LC(Letrozole combined with metronomic cyclophosphamide) for postmenopausal women with hormone receptor positive, operable and primary breast cancer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Phase II

Assessment
Primary outcomes Response rate
Key secondary outcomes Pathological CR rate, Breast Conserving Surgery rate, Safety, Disease- free survival and Overall survival

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 Letrozole 2.5mg p.o. daily and Cyclophosphamide 50mg p.o. daily for 24 weeks
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

Not applicable
Gender Female
Key inclusion criteria 1.Operable primary breast cancer(T2-4 N0-1 M0: at first diagnosis).
2.Histological confirmed invasive breast cancer by biopsy.
3.Estorogen receptor(ER) positive by Immunohistochemistry(IHC; >=10%).
4.Postmenopausal women and >=60 years old
5.Measurable region
6.Adequate major organ function;
WBC >= 3,000/mm3 <= 12,000/mm3 or ANC >= 1,500/mm3
PLT >= 100,000/mm3
Hb >= 9.5 g/dl
AST, ALT <= 1.5 x ULN
T. Bil <= 1.25 x ULN
Serum Cr. <= 1.5
Nomal ECG
EF >= 60%
7.ECOG preformance status (P.S.): 0 and 1
1.
8.Written informed consent
Key exclusion criteria 1. Prior chemotherapy or endocrine therapy
2. Under treatment by medicines with the possibility to affect the state of the sex hormone (hormone replacement therapy or raloxifene, etc)
3. Active double cancer
4. Inflammatory breast cancer
5. Bilateral breast cancer
6. History of drug-hypersensitivity
7. Under treatment of investigational new drug for other disease except breast cancer
8. Mental disease
9. Patient judged inappropriate for this study by the physicians
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Norikazu
Middle name
Last name Masuda
Organization National Hospital Organization Osaka Medical Center
Division name Department of Surgery
Zip code 540-0006
Address 2-1-14, Houenzaka, Chuo-ku, Osaka 540-0006
TEL 06-6946-5660
Email nmasuda@alpha.ocn.ne.jp

Public contact
Name of contact person
1st name Katsumasa
Middle name
Last name Kuroi
Organization Japan Breast Cancer Research Group (JBCRG)
Division name Head Office
Zip code 103-0016
Address 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
TEL 03-6264-8873
Homepage URL https://jbcrg.jp/
Email office@jbcrg.jp

Sponsor
Institute Japan Breast Cancer Research Group (JBCRG)
Institute
Department

Funding Source
Organization Japan Breast Cancer Research Group (JBCRG)
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 Japan Breast Cancer Research Group (JBCRG)
Address 9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
Tel 03-6264-8873
Email office@jbcrg.jp

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 大阪医療センター(大阪府)、京都大学医学部附属病院(京都府)、八尾市立病院(大阪府)、市立堺病院(大阪府)

Other administrative information
Date of disclosure of the study information
2008 Year 08 Month 22 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Completed
Date of protocol fixation
2007 Year 07 Month 02 Day
Date of IRB
2007 Year 10 Month 10 Day
Anticipated trial start date
2008 Year 02 Month 07 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Presentation: ASCO(2011)

Management information
Registered date
2008 Year 08 Month 21 Day
Last modified on
2019 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001613

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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