UMIN-CTR Clinical Trial

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
Email	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
Email	skuba@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

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
Email

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017698