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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007751
Receipt No. R000009127
Scientific Title Evaluation of Efficacy and Safty of Neo-adjuvant Chemo-endocrine Therapy in Luminal B(HER2-negative) Breast Cancer: A Prospective Multi-institutional Study
Date of disclosure of the study information 2012/04/13
Last modified on 2020/04/19

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Basic information
Public title Evaluation of Efficacy and Safty of Neo-adjuvant Chemo-endocrine Therapy in Luminal B(HER2-negative) Breast Cancer: A Prospective Multi-institutional Study
Acronym Evaluation of Efficacy and Safty of Neo-adjuvant Chemo-endocrine Therapy in Luminal B(HER2-negative) Breast Cancer: A Prospective Multi-institutional Study
Scientific Title Evaluation of Efficacy and Safty of Neo-adjuvant Chemo-endocrine Therapy in Luminal B(HER2-negative) Breast Cancer: A Prospective Multi-institutional Study
Scientific Title:Acronym Evaluation of Efficacy and Safty of Neo-adjuvant Chemo-endocrine Therapy in Luminal B(HER2-negative) Breast Cancer: A Prospective Multi-institutional Study
Region
Japan

Condition
Condition Luminal B (HER2-negative) primary breast cancer
Classification by specialty
Hematology and clinical oncology Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of efficacy and safty of Neo-adjuvant chemo-endocrine therapy in Luminal B (HER2-negative) breast cancer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase

Assessment
Primary outcomes pathological complete response rate
Key secondary outcomes clinical response rate
adverse events
histological therapeutic effect
breast conserving rate
Health related quality of life

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After 12 cycles of weekly paclitaxel followed by 4 cycles of AC (or EC), surgical resection is carried out.
Interventions/Control_2 After 12 cycles of weekly paclitaxel plus anastrozole followed by 4 cycles of AC (or EC) plus anastrozole, surgical resection is carried out.
(If patient is premenopausal, LH-RH agonist is added.)
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

Not applicable
Gender Female
Key inclusion criteria 1)Female patients with histologically confirmed invasive breast cancer
2)Any T-Stage
3)HER2-negative
4)Either ER -positive or PgR-positive
5)Either Ki67-LI>=14% and NG>=2 or NG=3 regardless of Ki67-LI
6)No significant abnormal EKG
7)No prior treatment for breast cancer
8)No history of breast cancer and no synchronous bilateral breast cancer
9)ECOG PS 0-1
10)Sufficient organ function confirmed with following major examination
WBC>=3000/mm3
Plt>=100000/mm3
Hb>=9.0g/dL
T-Bil<=1.5mg/dL
AST,ALT<=2.5 times ULN
Cre<=1.5mg/dL
No concurrent treatment for cerebral infarction at the registration.
No history of myocardial infarction and congestive heart failure.
No need for treatment of ischemic heart disease and valvular disorder
11)No distant metastasis
12)Written informed consent
Key exclusion criteria 1)Serious drug hypersensitivity
2)Pregnant or lactation women, or women with suspected pregnancy
3)Other any cancer
4)Other severe complications
5)Severe mental disorders
6)Active bleeding of digestive tract
7)Serious myeloablation,renal insufficciency,liver failure
8)Massive hydrothorax or ascites
9)Diarrhea
10)Active infection
11)Under treatment with continuous systemic steroid, estrogen or selective estrogen receptor modulators
12)Active participant in any other clinical trial for breast cancer
13)Not suitable for participating in the study for any other reason
Target sample size 94

Research contact person
Name of lead principal investigator
1st name Hiroyuki
Middle name
Last name Ogura
Organization Hamamatsu University School of Medicine
Division name First Department of Surgery
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka, Japan
TEL 053-435-2276
Email h.ogura@hama-med.ac.jp

Public contact
Name of contact person
1st name Ryoichi
Middle name
Last name Matsunuma
Organization Hamamatsu University School of Medicine
Division name First Department of Surgery
Zip code 431-3192
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka, Japan
TEL 053-435-2276
Homepage URL
Email r-matsu@hama-med.ac.jp

Sponsor
Institute Hamamatsu Breast Cancer Team
Institute
Department

Funding Source
Organization Hamamatsu University School 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 Hamamatsu University School of Medicine IRB
Address 1-20-1 Handayama, Higashi-ku, Hamamatsu-shi, Shizuoka, Japan
Tel 053-435-2680
Email rinri@hama-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 04 Month 13 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results Published

Result
URL related to results and publications https://www.ncbi.nlm.nih.gov/pubmed/32144735
Number of participants that the trial has enrolled 70
Results
In patients with luminal B-like breast cancer, the pCR, clinical response rate, toxicity, and HRQOL with the concomitant administration of endocrine therapy and chemotherapy were not superior to chemotherapy alone in the preoperative setting.
Results date posted
2020 Year 04 Month 19 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Refer to "Breast Cancer. 2020 Mar 6. doi: 10.1007/s12282-020-01077-0".
Participant flow
Refer to "Breast Cancer. 2020 Mar 6. doi: 10.1007/s12282-020-01077-0".
Adverse events
Refer to "Breast Cancer. 2020 Mar 6. doi: 10.1007/s12282-020-01077-0".
Outcome measures
Refer to "Breast Cancer. 2020 Mar 6. doi: 10.1007/s12282-020-01077-0".
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2012 Year 02 Month 01 Day
Date of IRB
2012 Year 03 Month 26 Day
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2017 Year 04 Month 01 Day
Date of closure to data entry
2017 Year 04 Month 01 Day
Date trial data considered complete
2017 Year 04 Month 01 Day
Date analysis concluded
2017 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2012 Year 04 Month 13 Day
Last modified on
2020 Year 04 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009127

Research Plan
Registered date File name
2020/04/19 HBCT臨床試験 プロトコール ver1.2.2.doc

Research case data specifications
Registered date File name

Research case data
Registered date File name


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