UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006946 |
|---|---|
| Receipt number | R000008207 |
| Scientific Title | Efficacy and safety of neoadjuvant CEX-XT treatment for triple-negative breast cancer |
| Date of disclosure of the study information | 2012/01/01 |
| Last modified on | 2020/01/04 08:04:17 |
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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
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
ymiyoshi@hyo-med.ac.jp
Sponsor or person
Institute
Department of breast and endocrine surgery, Hyogo college of medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008207
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
