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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014163
Receipt No. 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

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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
Email 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
Email neo-eribulin@ml.res.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016482

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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