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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000001214
Receipt No. R000001477
Scientific Title Phase II study of Neoadjuvant Letrozole and Docetaxel for Postmenopausal, Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-05)
Date of disclosure of the study information 2008/06/27
Last modified on 2019/11/21

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Basic information
Public title Phase II study of Neoadjuvant Letrozole and Docetaxel for Postmenopausal, Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-05)
Acronym JBCRG-05
Scientific Title Phase II study of Neoadjuvant Letrozole and Docetaxel for Postmenopausal, Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-05)
Scientific Title:Acronym JBCRG-05
Region
Japan

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

Objectives
Narrative objectives1 Evaluation of the response rate, the pathological response and the safety of neoadjuvant Letrozole combined with Docetaxel x 4 courses for postmenopausal women with hormone receptor positive, operable and primary breast cancer which confirmed SD or PD in prior anthracycline-containing chemotherapy.
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 daily for 12 weeks to 18 weeks and Docetaxel 75mg/m2 x 4 courses
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
50 years-old <=
Age-upper limit
70 years-old >
Gender Female
Key inclusion criteria 1. Operable primary breast cancer(T1c-3 N0 M0 / T1-3 N1 M0: at first diagnosis).
2. Histological confirmed invasive breast cancer by biopsy.
3. Estorogen receptor(ER) and/or Progesterone receptor(PgR) positive by Immunohistochemistry(IHC; >=10%).
4. All of the following patients that received 2-4 cycles of anthracycline-containing regimen.
i) SD/PD on CT/MRI confirmed by RECIST
ii) >=75% relative dose intensity in one of the following regimens;
FEC75-100, AC 60/600, EC 75-90/600
iii) SD >= 3 cycles, PD >= 2 cycles
5. Postmenopausal women when receiving the anthracycline-containing chemotherapy
6. Measurable region
7. Adequate major organ function;
WBC >= 3,000/mm3 <= 12,000/mm3 or ANC >= 1,500/mm3
PLT >= 100,000/mm3
Hb >= 9.6 g/dl
AST, ALT <= 1.5 x ULN
T. Bil <= 1.25 x ULN
Serum Cr. <= 1.5
Nomal ECG
EF >= 60%
8. ECOG preformance status (P.S.): 0 and 1
9. Age: <= 70
10. Possible to provide the biopsy
specimens, isolated tissues and
blood samples for this study.
11. Written informed consent
Key exclusion criteria 1. Unmanageable serious complications
2. HCV
3. Unmanageable diabetes
4. Suspicious infection with fever
5. Active double cancer
6. Neuropathy
7. Edema
8. Inflammatory breast cancer
9. Bilateral breast cancer
10. History of drug-hypersensitivity
11. Under treatment of continuous systematic steroids, estrogen and raloxifene
12. Serious mental disease
13. Patient judged inappropriate for this study by the physicians
Target sample size 33

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Nakayama
Organization Graduate School of Medicine Osaka University
Division name Department of Breast and Endocrine Surgery
Zip code 565-0871
Address 2-2 Yamadaoka Suita, Osaka 565-0871 Japan
TEL 06-6879-3772
Email nakayama-ta@mc.pref.osaka.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

Other administrative information
Date of disclosure of the study information
2008 Year 06 Month 27 Day

Related information
URL releasing protocol N/A
Publication of results Unpublished

Result
URL related to results and publications N/A
Number of participants that the trial has enrolled 3
Results
N/A
Results date posted
2019 Year 11 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
N/A
Participant flow
N/A
Adverse events
N/A
Outcome measures
N/A
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2007 Year 07 Month 02 Day
Date of IRB
2007 Year 09 Month 04 Day
Anticipated trial start date
2007 Year 08 Month 01 Day
Last follow-up date
2015 Year 02 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
2008 Year 06 Month 27 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=R000001477

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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