UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026143 |
|---|---|
| Receipt number | R000030036 |
| Scientific Title | Phase 2 study of dose-dense nab-paclitaxel followed by EC as neoadjuvant chemotherapy for HER2-negative breast cancer |
| Date of disclosure of the study information | 2017/02/20 |
| Last modified on | 2020/02/18 13:44:45 |
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Basic information
Public title
Phase 2 study of dose-dense nab-paclitaxel followed by EC as neoadjuvant chemotherapy for HER2-negative breast cancer
Acronym
Phase 2 study of dose-dense nab-paclitaxel followed by EC as neoadjuvant chemotherapy for HER2-negative breast cancer
Scientific Title
Phase 2 study of dose-dense nab-paclitaxel followed by EC as neoadjuvant chemotherapy for HER2-negative breast cancer
Scientific Title:Acronym
Phase 2 study of dose-dense nab-paclitaxel followed by EC as neoadjuvant chemotherapy for HER2-negative breast cancer
Region
| Japan |
Condition
Condition
HER2-negative primary breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of dose-dense Nab-PTX followed by EC as neoadjuvant chemotherapy for HER2-negative primary breast cancer. To evaluate the effect of cryotherapy and compression therapy using stockings, and prophylactic medication including goshajinkigan, mecobalamin and lafutidine for prevention of nab-PTX- induced peripheral neuropathy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological complete response rate
Key secondary outcomes
Clinical response rate, disease-free survival, adverse events, the evaluation of peripheral neuropathy by Patient Neurotoxicity Questionnaire (PNQ), the evaluation of QOL by FACT-Taxane
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 | Device,equipment |
Interventions/Control_1
Neoadjuvant chemotherapy with 4 cycles of dose-dense (every 2 week) Nab-PTX (260mg/m2) followed by 4 cycles of dose-dense (every 2 week) EC therapy (epirubicin 90 mg/m2 and CPA 600 mg/m2). Pegfilgrastim (3.6mg) will be administered on day2 or 3 of every cycle.
Patients will receive cryotherapy using ice and wear elastic stockings during nab-PTX administration, and will receive prophylactic medication over the course of treatment; including goshajinkigan (7.5 g/day), mecobalamin (1,500 ug/day) and lafutidine (20 mg/day).
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
| Not applicable |
Gender
Female
Key inclusion criteria
1) Female breast cancer histologically diagnosed HER2-negative primary invasive breast cancer
2) Stage 1-3
3) No previous treatment for breast cancer
4) 20 years old or older
5) Performance Status (PS) 0-1
6) Results from a laboratory test meet the following:
Leukocyte count is >=3000/mm3 or
Neutrophil count is >=2000/mm3
Platelet >=100 000/mm3
Hemoglobin >=9.0g/dL
AST and ALT <=x 1.5 of upper limit of normal (ULN)
Total bilirubin <=x 1.5 of ULN
Serum creatinine <=x 1.5 of ULN
7) No poorly controlled complication
8) Signed written informed consent
Key exclusion criteria
1) Women who are pregnant or lactating
2) Multiple primary cancer
3) HER2-positive breast cancer
4) Poorly controlled complication (interstitial pneumonia, severe diabetes, heart failure, renal insufficiency, hepatic insufficiency)
5) Active infection
6) Serious peripheral neuropathy (>=CTCAE grade2)
7) Ineligible based on decision of an investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Jinno |
Organization
Teikyo University School of Medicine
Division name
Department of Surgery
Zip code
173-8606
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL
+81-3-3964-1211
jinno@med.teikyo-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiromitsu |
| Middle name | |
| Last name | Jinno |
Organization
Teikyo University School of Medicine
Division name
Department of Surgery
Zip code
173-8606
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
TEL
+81-3-3964-1211
Homepage URL
jinno@med.teikyo-u.ac.jp
Sponsor or person
Institute
Teikyo University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Teikyo University School of Medicine
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
Teikyo university institutional review board
Address
2-11-1 Kaga, Itabashi-ku, Tokyo, Japan
Tel
03-3964-7256
turb-office@teikyo-u.ac.jp
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 | 02 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 01 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 20 | 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 | 02 | Month | 15 | Day |
Last modified on
| 2020 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030036
