UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001325 |
|---|---|
| Receipt number | R000001608 |
| Scientific Title | Phase II study of Neoadjuvant Letrozole for Postmenopausal Women with Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-06) |
| Date of disclosure of the study information | 2008/09/01 |
| Last modified on | 2019/11/21 16:43:58 |
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Basic information
Public title
Phase II study of Neoadjuvant Letrozole for Postmenopausal Women with Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-06)
Acronym
JBCRG-06
Scientific Title
Phase II study of Neoadjuvant Letrozole for Postmenopausal Women with Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-06)
Scientific Title:Acronym
JBCRG-06
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 for postmenopausal women with hormone receptor positive, operable and primary breast 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
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
| 75 | 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. HER2 <= 2+ or FISH negative
5. 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
6. Postmenopausal women when receiving the anthracycline-containing chemotherapy
7. Measurable region
8. 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
9. ECOG preformance status (P.S.): 0 and 1
10. Age: <= 75
11. Possible to provide the biopsy
specimens, isolated tissues and
blood samples for this study.
12. 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. Inflammatory breast cancer
7. Bilateral breast cancer
8. 10. History of drug-hypersensitivity
9. Receiving continuous systematic steroids, estrogen and Raloxifene
10. Mental disease
11. Patient judged inappropriate for this study by the physicians
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Kashiwaba |
Organization
School of Medicine, Iwate Medical School
Division name
Department of Surgery
Zip code
020-8505
Address
19-1, Uchimaru, Morioka-shi, Iwate
TEL
019-651-5111
mkashiwa@iwate-med.ac.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/
office@jbcrg.jp
Sponsor or person
Institute
Japan Breast Cancer Research Group (JBCRG)
Institute
Department
Personal name
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
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 | 09 | Month | 01 | 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
0
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 | 09 | Month | 07 | Day |
Date of IRB
| 2008 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 09 | 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 | 08 | Month | 20 | Day |
Last modified on
| 2019 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001608
