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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008423
Receipt No. R000009912
Scientific Title Single institute phase II study of neoadjuvant chemotherapy with trastuzumab and letrozole for postmenopausal ER-positive/HER2-positive breast cancers
Date of disclosure of the study information 2012/07/16
Last modified on 2020/03/15

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Basic information
Public title Single institute phase II study of neoadjuvant chemotherapy with trastuzumab and letrozole for postmenopausal ER-positive/HER2-positive breast cancers
Acronym NeoTL study
Scientific Title Single institute phase II study of neoadjuvant chemotherapy with trastuzumab and letrozole for postmenopausal ER-positive/HER2-positive breast cancers
Scientific Title:Acronym NeoTL study
Region
Japan

Condition
Condition Breast Cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate efficacy of concurrent use of chemotherapy with trastuzumab and letrozole for postmenopausal breast cancers with ER-positive/HER2-positive.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall Response Rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
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/day, 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

Not applicable
Age-upper limit
75 years-old >=
Gender Female
Key inclusion criteria 1) Stage2A, 2B, 3A, 3B breast cancer
2) Histologically confirmed breast cancer
3) Postmenopausal women
4) ER- and/or PgR-positive (10% or more cancer cells were positive)
5) HER2-psotive (IHC score 3, or IHC score 2+ and FISH-positive)
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 or fobrosis 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 40

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, Ninshinomiya, Hyogo
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 Hyogo College of medicine
Division name Breast and endocrine Surgery
Zip code 663-8501
Address 1-1 Mukogawa, Nishinomiya City, Hyogo, Japan
TEL 0798-45-6374
Homepage URL
Email ymiyoshi@hyo-med.ac.jp

Sponsor
Institute Department of Breast and Endocrine Surgery, Hyogo College of medicine
Institute
Department

Funding Source
Organization Breast and Endocrine Surgery, Hyogo College of Medicine
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 Unpublished
Publication of results Unpublished

Result
URL related to results and publications No publication
Number of participants that the trial has enrolled 0
Results
No patient was recruited.
Results date posted
2020 Year 03 Month 15 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No patient was recruited.
Participant flow
No patient was recruited.
Adverse events
No patient was recruited.
Outcome measures
No patient was recruited.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Terminated
Date of protocol fixation
2012 Year 07 Month 10 Day
Date of IRB
2012 Year 07 Month 25 Day
Anticipated trial start date
2012 Year 08 Month 01 Day
Last follow-up date
2014 Year 06 Month 30 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 13 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/ctr_e/ctr_view.cgi?recptno=R000009912

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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