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

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 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


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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017698


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name