UMIN-CTR Clinical Trial

Basic information
Public title	Randomized phase II study of neoadjuvant chemotherapy with or without letrozole for postmenopausal ER-positive/HER2-negative breast cancers
Acronym	KBCOG 10
Scientific Title	Randomized phase II study of neoadjuvant chemotherapy with or without letrozole for postmenopausal ER-positive/HER2-negative breast cancers
Scientific Title:Acronym	KBCOG 10
Region	Japan

Condition
Condition	Postmenopausal breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluate efficacies of neoajuvant chemotherapy with letrozole on patients with psotmenopausal ER-positive and HER2-negative.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Overall Response Rate
Key secondary outcomes	Pathological complete response rate, Breast conserving rate, Safety, Disease-free survival, Overall survival

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	letrozole, 25mg/day, 24 weeks
Interventions/Control_2	without letrozole
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	Not applicable
Age-upper limit	75 years-old >=
Gender	Female
Key inclusion criteria	1) Stage2A, 2B, 3A, 3B breast cancer 2) Histologically or cytologically confirmed breast cancer 3) Postmenopausal women 4) ER-positive (10% or more cancer cells were positive) 5) HER2-negatie (IHC score 0, 1+, or IHC score 2+ and FISH-negative) 6) 75 years old or less 7) Performance status 0 or 1 8) Breast cancers with evaluable lesion 9) Sufficient organ function meeting following criteria: (1) Leukocyte > 3000 mm3 or Neutrophil >1500 mm3 (2) Hemoglobin >9.0g/dL (3) Platelet >100000 mm3 (4) AST (GOT) and ALT(GPT) < 2.5 x upper limit of normal (ULN) (5) Serum total bilirubin <1.5 mg/dL (6) Serum creatinine <1.5 mg/dL (7) Normal electrocardiogram (8) LVEF is >55% measured by echocardiography or MUGA scan 10) No finding of pneumonitis by Chest CT or X-ray 11) MRI or CT of the breast must be done pre- and post-chemotherapy 12) No prior treatment for breast cancers 13) Signed written informed consent
Key exclusion criteria	1) Inflammatory breast cancer 2) Bilateral breast cancers without DCIS or ICIS 3) With multiple cancers diagnosed with 5 years 4) With uncontrollable hypertension, angina pectoris, congestive heart failure 5) With severe complication including infection or uncontrolled diabetes mellitus 6) With viral hepatitis (HBs antigen- or HCV antibody-positive) 7) Patients treated with endocrine therapy 8) Infection or possible infection associated with clinical symptoms such as fever 9) With severe edema 10) With severe mental disorder 11) Cases who physician judged improper to entry this trial
Target sample size	70

Research contact person
Name of lead principal investigator	1st name Yasuo Middle name Last name Miyoshi
Organization	Hyogo College of Medicine
Division name	Breast and Endocrine Surgery
Zip code	663-8501
Address	Mukogawa 1-1, Nishinomiya, Hyogo 663-8501
TEL	0798-45-6374
Email	ymiyoshi@hyo-med.ac.jp

Public contact
Name of contact person	1st name Yasuo Middle name Last name Miyoshi
Organization	Kobe Breast Cancer Oncology Group
Division name	Hyogo College of medicine
Zip code	663-8501
Address	Mukogawa 1-1, Nishinomiya, Hyogo 663-8501
TEL	0798-45-6374
Homepage URL
Email	ymiyoshi@hyo-med.ac.jp

Sponsor
Institute	Kobe Breast Cancer Oncology Group
Institute
Department

Funding Source
Organization	Kobe Breast Cancer Oncology Group
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	Institutional Review Board of Hyogo College of Medicine
Address	Mukogawa 1-1, Nishinomiya City
Tel	0798456374
Email	rinri@hyo-med.ac.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	2012 Year 07 Month 16 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	2012 Year 06 Month 20 Day
Date of IRB	2012 Year 07 Month 07 Day
Anticipated trial start date	2012 Year 07 Month 10 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2012 Year 07 Month 12 Day
Last modified on	2020 Year 03 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009898