UMIN-CTR Clinical Trial

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
Email	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/
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

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001613