UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015224 |
|---|---|
| Receipt number | R000017698 |
| Scientific Title | Studies to examine the best tumor reduction rate for predicting the pCR after two cycles docetaxel chemotherapy breast preoperative |
| Date of disclosure of the study information | 2014/10/01 |
| Last modified on | 2021/01/12 15:19:56 |
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Basic information
Public title
Studies to examine the best tumor reduction rate for predicting the pCR after two cycles docetaxel chemotherapy breast preoperative
Acronym
Studies to examine the best tumor reduction rate for predicting the pCR after two cycles docetaxel chemotherapy breast preoperative
Scientific Title
Studies to examine the best tumor reduction rate for predicting the pCR after two cycles docetaxel chemotherapy breast preoperative
Scientific Title:Acronym
Studies to examine the best tumor reduction rate for predicting the pCR after two cycles docetaxel chemotherapy breast preoperative
Region
| Japan |
Condition
Condition
Invasive breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Reveal the optimal modality cutoff value for starting docetaxel neoadjuvant chemotherapy, to predict the effect determination pCR after 2 cycles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cut-off value of tumor reduction rate by US evaluation for pCR prediction of chemotherapy breast cancer preoperative.
Key secondary outcomes
-Pathological response caliper, MMG, a contrast MRI, by needle biopsy, Ki67,optimal modalities US for predicting the pCR of breast cancer chemotherapy before surgery.
-Treatment discontinuation rate due to evaluation after 2 cycles.
-Safety
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
And chemotherapy two cycles enforcement preoperative, performing a therapeutic effect judgment. If the disease has progressed obviously, to stop the treatment.
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
| 20 | years-old | <= |
Age-upper limit
| 71 | years-old | >= |
Gender
Female
Key inclusion criteria
1.It is diagnosed with invasive breast cancer histologically, female patients T1c-T3 without the entire treatment, N0-2.of M0.
2.Over 20 years old,71years old
3.HER2 positive breast cancer and/or triple negative breast cancer
4.ECOG performance status(PS)0-1
5.Patient consent was obtained in writing for participation in this study from the subject herself.
Key exclusion criteria
1. Patient with suspected infection has a fever or a patient, has been complicated by infection.
2. Patients with drug allergies severe.
3. Renal failure severe, patients with (jaundice) liver failure.
4. Patients with pulmonary fibrosis or interstitial pneumonia evident in chest X-ray.
5. Enhanced MRI of patients contraindicated
6. Patients with hypertension, diabetes uncontrolled.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sayaka Kuba |
Organization
Nagasaki University Hospital
Division name
Depertment of SURGERY
Zip code
Address
nagasaki sakamoto1-7-1
TEL
095-819-7316
skuba@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sayaka KUba |
Organization
Nagasaki University Hospital
Division name
Depertment of SURGERY
Zip code
Address
nagasaki sakamoto1-7-1
TEL
095-819-7316
Homepage URL
skuba@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Address
Tel
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
長崎労災病院
長崎医療センター
長崎みなとメディカル市民病院
長崎県島原病院
国立病院機構佐賀病院
長崎大学病理検査部
長崎大学臨床研究センター
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2014 | Year | 09 | Month | 09 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | 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
| 2014 | Year | 09 | Month | 22 | Day |
Last modified on
| 2021 | Year | 01 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017698
