UMIN-CTR Clinical Trial

Basic information
Public title	Phase II study of Neoadjuvant Letrozole for Postmenopausal Women with Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-06)
Acronym	JBCRG-06
Scientific Title	Phase II study of Neoadjuvant Letrozole for Postmenopausal Women with Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-06)
Scientific Title:Acronym	JBCRG-06
Region	Japan

Condition
Condition	Postmenopausal, hormone-receptor positive and primary breast cancer
Classification by specialty	Hematology and clinical oncology Surgery in general Breast surgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	Evaluation of the response rate, the pathological response and the safety of neoadjuvant Letrozole for postmenopausal women with hormone receptor positive, operable and primary breast which confirmed SD or PD in prior anthracycline-containing chemotherapy.
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 daily for 12 weeks to 18 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	75 years-old >=
Gender	Female
Key inclusion criteria	1. Operable primary breast cancer(T1c-3 N0 M0 / T1-3 N1 M0: at first diagnosis). 2. Histological confirmed invasive breast cancer by biopsy. 3. Estorogen receptor(ER) and/or Progesterone receptor(PgR) positive by Immunohistochemistry(IHC; >=10%). 4. HER2 <= 2+ or FISH negative 5. All of the following patients that received 2-4 cycles of anthracycline-containing regimen. i) SD/PD on CT/MRI confirmed by RECIST ii) >=75% relative dose intensity in one of the following regimens; FEC75-100, AC 60/600, EC 75-90/600 iii) SD >= 3 cycles, PD >= 2 cycles 6. Postmenopausal women when receiving the anthracycline-containing chemotherapy 7. Measurable region 8. Adequate major organ function; WBC >= 3,000/mm3 <= 12,000/mm3 or ANC >= 1,500/mm3 PLT >= 100,000/mm3 Hb >= 9.6 g/dl AST, ALT <= 1.5 x ULN T. Bil <= 1.25 x ULN Serum Cr. <= 1.5 Nomal ECG 9. ECOG preformance status (P.S.): 0 and 1 10. Age: <= 75 11. Possible to provide the biopsy specimens, isolated tissues and blood samples for this study. 12. Written informed consent
Key exclusion criteria	1. Unmanageable serious complications 2. HCV 3. Unmanageable diabetes 4. Suspicious infection with fever 5. Active double cancer 6. Inflammatory breast cancer 7. Bilateral breast cancer 8. 10. History of drug-hypersensitivity 9. Receiving continuous systematic steroids, estrogen and Raloxifene 10. Mental disease 11. Patient judged inappropriate for this study by the physicians
Target sample size	33

Research contact person
Name of lead principal investigator	1st name Masahiro Middle name Last name Kashiwaba
Organization	School of Medicine, Iwate Medical School
Division name	Department of Surgery
Zip code	020-8505
Address	19-1, Uchimaru, Morioka-shi, Iwate
TEL	019-651-5111
Email	mkashiwa@iwate-med.ac.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

Other administrative information
Date of disclosure of the study information	2008 Year 09 Month 01 Day

Related information
URL releasing protocol	N/A
Publication of results	Unpublished

Result
URL related to results and publications	N/A
Number of participants that the trial has enrolled	0
Results	N/A
Results date posted	2019 Year 11 Month 21 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	N/A
Participant flow	N/A
Adverse events	N/A
Outcome measures	N/A
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Terminated
Date of protocol fixation	2007 Year 09 Month 07 Day
Date of IRB	2008 Year 01 Month 18 Day
Anticipated trial start date	2007 Year 10 Month 01 Day
Last follow-up date	2015 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	2008 Year 08 Month 20 Day
Last modified on	2019 Year 11 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001608