UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phase II study of Neoadjuvant Eribulin followed by FEC for operable triple-negative breast cancer
Title of the study (Brief title)	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	Kan Yonemori
Organization	National Cancer Center Hospital
Division name	Breast and Medical Oncology Division
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	Tomomi Hata
Organization	National Cancer Center Center for Research Administration and Support
Division name	Research Management Section Research Coordination Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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