UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029433
Receipt No. R000029940
Scientific Title Prospective study of neoadjuvant chemotherapy with FEC100x4 for BRCAness cases in triple negative breast cancer
Date of disclosure of the study information 2017/10/05
Last modified on 2017/10/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Prospective study of neoadjuvant chemotherapy with FEC100x4 for BRCAness cases in triple negative breast cancer
Acronym Neoadjuvant chemotherapy for BRCAness
Scientific Title Prospective study of neoadjuvant chemotherapy with FEC100x4 for BRCAness cases in triple negative breast cancer
Scientific Title:Acronym Neoadjuvant chemotherapy for BRCAness
Region
Japan

Condition
Condition Breast cancer
Classification by specialty
Breast surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The efficacy of anthracycline based chemotherapy is investigated for BRCAness
homologous recombination deficiency cases in triple negative breast cancer patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes pathologic complete response(pCR)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Patients who have obtained consent from tis study will start neoadjuvant chemotherapy with the following 3 anti-cancer drugs every 3 weeks for a total of 4 cycles.
Fluorouracil 500mg/m2 Epirubicin 100mg/m2 Cyclophosphamide 100m/m2
BRCAness is examined and cases with non-BRCAness will be taken Taxan every 3 weeks, for a total of 4 cycles.
Interventions/Control_2 Cases with BRCAness will undergo surgery without adding Taxan. If pCR is not obtained, Taxan will be given.

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
75 years-old >=
Gender Female
Key inclusion criteria 1.Patients with primary breast cancer who indicates the neoadjuvant chemotherapy from stage 1-3
2.PS 0-1
3.normal cardiac function
4.clinical examination is normal
Key exclusion criteria 1.Patients who have been administered moderate doses of anti-cancer drugs.
2.Patients who have been undergone gastrointestinal surgery
3.Active double cancers
4.Pregnant, lactating, possible pregnancy, having oral contraceptive
5.Patients who the investigator judged unsuitable for this trial
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Ishikawa
Organization Tokyo medical university hospital
Division name breast oncology
Zip code
Address 6-1-1 Nishishinnjyuku Shinjyuku-ku Tokyo
TEL 0333516141
Email tishik55@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Saeko Teraoka
Organization Tokyo medical university hospital
Division name breast oncology
Zip code
Address 6-1-1 Nishishinnjyuku Shinjyuku-ku Tokyo
TEL 0333516141
Homepage URL
Email s_teraoka0809@yahoo.co.jp

Sponsor
Institute Tokyo medical university
Institute
Department

Funding Source
Organization Tokyo medical university cancer institute.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor FALCO biosystems
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

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 05 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 Enrolling by invitation
Date of protocol fixation
2015 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 05 Day
Last modified on
2017 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029940

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.