UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Letrozole combined with Cyclophosphamide and Capecitabine(LCX) for Hormone-Sensitive advanced breast cancer(age over 65) (JBCRG-14)
Title of the study (Brief title)	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	Takahiro Nakayama
Organization	Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name	Department of breast and endocrine surgery
Address	1-3-3, Nakamichi, Higashinari, Osaka, 537-0025, Japan
TEL	06-6972-1181
Email	taqnakayama@hotmail.com

Public contact
Name of contact person	Katsumasa Kuroi
Organization	Japan Breast Cancer Research Group (JBCRG)
Division name	Head Office
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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2011 Year 10 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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