UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007751 |
|---|---|
| Receipt number | 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 12:53:29 |
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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
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
r-matsu@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu Breast Cancer Team
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
