UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001331 |
|---|---|
| Receipt number | 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 | 2021/08/18 09:41:00 |
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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
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/
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
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
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Publication of results
Published
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
41
Results
Results:
The CRR was 67.5% '52.0-80.0%).
No patients achieved pCR. Seven patients (17.5%) showed grade 2 pathological responses and 28 (70%) showed grade 1 responses.
Conclusion:
Metronomic chemo-endocrine therapy with letrozole plus cyclophosphamide showed a good response and was tolerated in Japanese postmenopausal patients with ER-positive breast cancer.
Results date posted
| 2021 | Year | 08 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2018 | Year | 05 | Month | 07 | Day |
Baseline Characteristics
Postmenopausal patients with
estrogen receptor-positive breast
cancer
Participant flow
Single-arm neoadjuvant therapy with letrozole and cyclophosphamide was conducted.
Adverse events
Twenty-two patients (54%) had
leukocytopenia, but most (17/22)
of them were grade 1. Grade 3 leukocytopenia was observed
in one patient. The most common
nonhematological AE was arthralgia, which was observed
in six patients.
Outcome measures
Primary endpoint: clinical response rate (CRR)
Secondary endpoints:
pathological therapeutic
effects,
breast conservation rate,
safety
disease-free survival (DFS) overall survival (OS).
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
| 2021 | Year | 08 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001613
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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