UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of neoadjuvant CEX-XT treatment for triple-negative breast cancer
Acronym	NeoXX trial
Scientific Title	Efficacy and safety of neoadjuvant CEX-XT treatment for triple-negative breast cancer
Scientific Title:Acronym	NeoXX trial
Region	Japan

Condition
Condition	Triple-negative breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluate efficacy and safety of neoadjuvant treatment using CEX (cyclophosphamideepirubicin, capecitabine)-XT(capecitabine, docetaxel) for triple-negative breast cancers
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pathological complete response
Key secondary outcomes	Clinical response, breast conserving rate, safety, DFS, OS

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	cyclophosphamide, epirubicin, capecitabine, docetaxel
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	70 years-old >=
Gender	Female
Key inclusion criteria	1. Histologically confirmed breast cancer aged between 20-70 years old female 2. Operable stage I-III (TNM) breast cancers 3. Estrogen receptor negative 4. Progesterone receptor negative 5. HER 2 negative: either 0, 1, 2 expression by IHC and FISH-negative 6. No prior treatment for breast cancer including chemotherapy, radiotherapy, endocrine therapy, immunotherapy 7. PS: 0-1 (ECOG) 8. Signed written informed consent
Key exclusion criteria	1. Another cancer diagnosed within 5 years 2. Pregnant or nursing women 3. Male patients 4. With history of serious drug allergy 5. With interstitial pneumonitis or lung fibrosis 6. Infection or possible infection associated with clinical symptoms such as fever 7. With symptom of varicella 8. With uncontrollable pleural effusion, or pericardial effusion 9. With severe edema 10. With severe peripheral neuropathy 11. Usual treatment with steroid 12. With severe psychological complication 13. Bilateral breast cancer 14. Cases who physician judged improper to entry this trial
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yasuo Miyoshi
Organization	Hyogo college hospital
Division name	Department of breast and endocrine surgery
Zip code
Address	Mukogawa 1-1, Nishinomiya, Hyogo
TEL	0798-45-6374
Email	ymiyoshi@hyo-med.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yasuo Miyoshi
Organization	Hyogo college hospital
Division name	Department of breast and endocrine surgery
Zip code
Address	1-1 Mukogawa Nishinomiya
TEL	0798-45-6374
Homepage URL
Email	ymiyoshi@hyo-med.ac.jp

Sponsor
Institute	Department of breast and endocrine surgery, Hyogo college of medicine
Institute
Department

Funding Source
Organization	Department of breast and endocrine surgery, Hyogo college of medicine
Organization
Division
Category of Funding Organization	Other
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

Other administrative information
Date of disclosure of the study information	2012 Year 01 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	Terminated
Date of protocol fixation	2011 Year 06 Month 01 Day
Date of IRB	2011 Year 07 Month 01 Day
Anticipated trial start date	2012 Year 01 Month 01 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2011 Year 12 Month 25 Day
Last modified on	2020 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000008207