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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000006708
Receipt No. 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

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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
Email 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/
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 Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007909

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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