UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014163 |
|---|---|
| Receipt number | R000016482 |
| Scientific Title | Phase II study of Neoadjuvant Eribulin followed by FEC for operable triple-negative breast cancer |
| Date of disclosure of the study information | 2014/07/01 |
| Last modified on | 2018/07/01 17:58:59 |
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Basic information
Public title
Phase II study of Neoadjuvant Eribulin followed by FEC for operable triple-negative breast cancer
Acronym
A phase II study of Neoadjuvant Eribulin in TNBC patients
Scientific Title
Phase II study of Neoadjuvant Eribulin followed by FEC for operable triple-negative breast cancer
Scientific Title:Acronym
A phase II study of Neoadjuvant Eribulin in TNBC patients
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the efficacy and safety of Eribulin followed by FEC as neoadjuvant chemotherapy for operable triple-negative breast cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
Pathological complete response rate, which is defined as the absence of viable invasive tumor in both the breast and the axillary nodes, or residual ductal carcinoma in situ (DCIS) in breast and no viable invasive tumor in the axillary nodes.
Key secondary outcomes
1) Clinical response rate
2) Disease-free survival
3) Breast-conservation rate
4) Adverse events
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
Eribulin 1.4mg/m2 (day 1, 8) /q3wks x 4 courses, followd by FEC (cyclophosphamide/epirubicin/5-fluorouracil 500/100/500mg/m2/q3wks) x 4 courses
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
Disease Characteristics
1) Previously untreated, histological confirmation of invasive breast cancer.
2) Clinical stage II and IIIA
Patients with a tumor size; > 2.0 cm dimension by imaging test, or < 2.0 cm with axillary lymph node metastasis clinically diagnosed as positive, are eligible.
3) Histological confirmation of breast cancer without overexpression of HER2.
4) Histological confirmation of hormonal receptor-negative breast cancer (Allred Proportion Score < 1, or J-Score <1 in the IHC test for estrogen receptor and progesterone receptor).
Patient's Characteristics
1) Age of 20 and over years old.
2) PS (ECOG) 0 - 1
3) Patients with the following values in their latest laboratory tests
- Neutrophil count >1,500/m3
- Platelet count > 100,000/m3
- Serum AST/ALT < 100 IU/L
- Total bilirubin < 1.5 mg/dL
- Serum creatinine < 1.2 mg/dL
-ECG Normal or minimal changes not requiring treatment
4) Written informed consent was obtained from the patient.
Key exclusion criteria
1) Pregnant or breast-feeding women, or women of child bearing potential who intend to become pregnant
2) Patients with active infection
3) Patients with respiratory failure requiring oxygen inhalation therapy
4) Patients with signs or symptoms of interstitial pneumonia or pulmonary fibrosis
5) Patients who are HBs antigen-positive, HCV antibody-positive and/or HIV antibody-positive
6) Patients with diabetes mellitus associated with poor glycemic control
7) Patients with psychiatric illness that would prevent informed consent
8) Patients with history of allergy to eribulin mesylate, epirubicin hydrochloride, fluorouracil or cyclophosphamide hydrate
9) Patients with cancer within five years, not including breast cancer and lesions equivalent to carcinoma in situ or mucosal carcinoma considered healed with topical therapy
10) Patients with a history of invasive breast cancer
11) Prior treatment with Epirubicin Hydrochloride >500mg/m2
12) Patients who have a previous and concurrent inflammatory breast cancer
13) Patients otherwise considered ineligible for enrollment in the study by the investigator
Target sample size
43
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kan Yonemori |
Organization
National Cancer Center Hospital
Division name
Breast and Medical Oncology Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo104-0045, Japan
TEL
03-3542-2511
neo-eribulin@ml.res.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomomi Hata |
Organization
National Cancer Center Center for Research Administration and Support
Division name
Research Management Section Research Coordination Division
Zip code
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo104-0045, Japan
TEL
03-3542-2511
Homepage URL
neo-eribulin@ml.res.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
Eisai Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
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
国立研究開発法人国立がん研究センター中央病院（東京都）
独立行政法人国立病院機構北海道がんセンター（北海道）
千葉県がんセンター（千葉県）
独立行政法人国立病院機構大阪医療センター（大阪府）
独立行政法人国立病院機構四国がんセンター（愛媛県）
地方独立行政法人神奈川県立病院機構 神奈川県立がんセンター(神奈川県）
公益財団法人がん研究会有明病院（東京都）
独立行政法人国立がん研究センター東病院（千葉県）
聖路加国際病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | 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 | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2016 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 04 | Day |
Last modified on
| 2018 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016482
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| Registered date | File name |
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