UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006708 |
|---|---|
| Receipt number | R000007909 |
| Scientific Title | Phase II study of Letrozole combined with Cyclophosphamide and Capecitabine(LCX) for Hormone-Sensitive advanced breast cancer(age over 65) (JBCRG-14) |
| Date of disclosure of the study information | 2011/11/18 |
| Last modified on | 2018/08/24 10:06:03 |
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Basic information
Public title
Phase II study of Letrozole combined with Cyclophosphamide and Capecitabine(LCX) for Hormone-Sensitive advanced breast cancer(age over 65) (JBCRG-14)
Acronym
JBCRG-14
Scientific Title
Phase II study of Letrozole combined with Cyclophosphamide and Capecitabine(LCX) for Hormone-Sensitive advanced breast cancer(age over 65) (JBCRG-14)
Scientific Title:Acronym
JBCRG-14
Region
| Japan |
Condition
Condition
Postmenopausal, ER positive and HER2 negative advanced 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 , and the safety of Letrozole combined with Cyclophosphamide and Capecitabine (LCX) for Hormone-Sensitive advanced breast cancer(age over 65) .
At the same time, the breast-conserving surgery rate, relapse-free survival and overall survival will be assessed.
In addition, the clinical efficacy as well as biological properties of the cancer tissue will be investigated using molecular biological and biochemical techniques.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Overall Response Rate: ORR
Key secondary outcomes
Pathological Complete Response: pCR
Safety
Breast Conserving Rate: BCR
Disease-free Survival: DFS
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 and Capecitabine 1000mg/m2 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
| 65 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Female
Key inclusion criteria
1. Advanced breast cancer
2. Stage:IIA, IIB, IIIA
3. Histological confirmed invasive breast cancer by biopsy
4. Estorogen receptor(ER) positive by Immunohistochemistry(IHC; => 10% or Allred score => 3).
5. HER2 negative (IHC: 1+ or 0, or FISH: negative)
6. The patient is aged 65 to 79.
7. One of the following cases
1) Histologic grade: => Grade2
2) tumor size => 5cm
3) lymph node-positive
4) Ki67 => 15%
8. Measurable region
9. Principal organs (bone marrow, heart, liver, kidneys, etc.) are functionally preserved.
1)White blood cell count => 3,000/mm3
or Neutrophil count => 1,500/mm3
2)Platelet count => 100,000/mm3
3)Hemoglobin => 9.0 g/dL
4)AST, ALT <= 1.5 x Upper limit of
facility reference
5)Total bilirubin <= 1.25 x Upper limit of facility reference
6)ALP <= 1.25 x Upper limit of facility reference
7)Serum creatinine <= 1.5 x Upper
limit of facility reference
10. ECOG preformance status (P.S.): 0 and 1
11. Written informed consent
Key exclusion criteria
1. Prior chemotherapy or endocrine therapy
2. Need for treatment with taxanes and anthracycline drug
3. need of Treatment with hormone therapy alone
4. Medication that may affect the sex hormone status (hormone replacement therapy, raloxifene, etc.)
5. History or complications of uncontrolled hypertension, severe heart disease (heart failure, ischemic heart disease, endocarditis, valvular heart disease, pericarditis, and congenital heart disease)
6. Active double cancer
7. Inflammatory breast cancer
8. Bilateral breast cancer
9. Medication of investigational new drug
10. Cases in which study participation is considered difficult due to the coexistence of psychosis or psychiatric symptoms
11. Cases considered ineligible by the attending physician for other reasons
Target sample size
32
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takahiro Nakayama |
Organization
Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name
Department of breast and endocrine surgery
Zip code
Address
1-3-3, Nakamichi, Higashinari, Osaka, 537-0025, Japan
TEL
06-6972-1181
taqnakayama@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Katsumasa Kuroi |
Organization
Japan Breast Cancer Research Group (JBCRG)
Division name
Head Office
Zip code
Address
9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo 103-0016, Japan
TEL
03-6264-8873
Homepage URL
http://www.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
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
大阪労災病院(大阪府)
広島市民病院(広島県)
りんくう総合医療センター(大阪府）
八尾市立病院(大阪府)
都立駒込病院(東京都）
愛知県がんセンター中央病院(愛知県）
九州がんセンター(福岡県）
京都大学医学部付属病院(京都府)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2018 | 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
| 2011 | Year | 11 | Month | 11 | Day |
Last modified on
| 2018 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007909
| 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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| Registered date | File name |
