UMIN-CTR Clinical Trial

Basic information
Public title	Randomized Phase II trial of Neoadjuvant weekly Nab-paclitaxel followed by FEC compared with Docetaxel followed by FEC for early breast cancer
Acronym	ABI-007 Followed by FEC Neoadjuvant Chemotherapy for Breast Cancer (Randomized Phase II Trial)
Scientific Title	Randomized Phase II trial of Neoadjuvant weekly Nab-paclitaxel followed by FEC compared with Docetaxel followed by FEC for early breast cancer
Scientific Title:Acronym	ABI-007 Followed by FEC Neoadjuvant Chemotherapy for Breast Cancer (Randomized Phase II Trial)
Region	Japan

Condition
Condition	Breast Cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Evaluate the efficacy and safety of weekly Nab-paclitaxel followed by FEC as neoadjuvant chemotherapy for early breast cancer. Primary endpoint is to evaluate the pathological CR rate. Secondary endpoint is to evaluate the Clinical response rate, pathological response rate, breast conserving rate, and safety.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase II

Assessment
Primary outcomes	Primary endpoint is to evaluate the pathological CR rate.
Key secondary outcomes	Secondary endpoint is to evaluate the Clinical response rate, pathological response rate, breast conserving rate, and safety.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	After 4 course of Docetaxel and FEC, surgical resection is carried out. Docetaxel Docetaxel 75 mg/m2 is administered intravenously at day 1. One course is consisted by 3 weeks and repeated to 4 courses. FEC After administrated 4 courses of Docetaxel, FEC(5-FU 500mg/m2, Epi-ADM 100mg/m2 and CPA 500mg/m2 are administered at day1) is carried out. One course is consisted by 3 weeks and repeated to 4 courses.
Interventions/Control_2	After 4 course of Weekly Nab-paclitaxel and FEC, surgical resection is carried out. Weekly Nab-paclitaxel Weekly Nab-paclitaxel 100 mg/m2 is administered intravenously at day 1, 8, 15. One course is consisted by 4 weeks and repeated to 4 courses. FEC After administrated 4 courses of Docetaxel, FEC(5-FU 500mg/m2, Epi-ADM 100mg/m2 and CPA 500mg/m2 are administered at day1) is carried out. One course is consisted by 3 weeks and repeated to 4 courses.
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) Histologically confirmed primary breast cancer. 2) Clinical stage T1c-3 N0 M0 or T1-3 N1 M0 3) expected to radical cure by operation and neoadjuvant chemotherapy 4) has measurable region 5) Age more than 20 years old 6) no prior surgery, radiation, chemotherapy and endcrinethrapy 7) Required baseline laboratory parameters (within 14 days before registration): Hb more than 9.0g/dl WBC more than 3500 /mm3 and less than 12,000 /mm3 Neu more than 2000 / mm3 Plt more than 100,000/mm3 T-Bil less than 2 times ULM AST less than 100 IU/L ALT less than 100 IU/L Cre less than 1.5 mg/dL 8) ECOG performance status is 0 to 2 9) Signed informed consent of the patient for the registration.
Key exclusion criteria	1) History of sever hypersensitivity 2) Her 2 overexpression (3+ by IHC stain or 2+ and FISH positive) 3) Active other malignancies 4) Severe complications (infection, diarrhea, intestine on the paralyzed, and ileus which affect to treatment, uncontrolled diabetes mellitus, uncontrolled angina, heart infarction within 6 months, heart failure interstitial pneumonia or pulmonary fibrosis, cerebrovascular accident etc.) 5) has brain metastasis with symptoms 6) has psychological illness which became a problem in practice 7) received transfusion within 2 weeks because of bleeding in gastrointestinal tract 8) sever bone suppression, renal dysfunction, and liver dysfunction 9) sever pleural effusion or ascites fluid 10) water diarrhea at registration 11) has infection or fever which suspected of infection 12) history of hypersensitivity to Nab-paclitaxel, paclitaxel or albumin 13) pregnant or possibility of pregnant 14) history of sever hypersensitivity to docetaxel or polysorbate-containing product 15) Patients judged inappropriate by physicians
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Seigo Middle name Last name Nakamura
Organization	Showa University
Division name	Department of Breast Surgical Oncology
Zip code	142-8666
Address	1-5-8, hatanodai, shinagawaku, Tokyo, japan
TEL	03-3784-8727
Email	breastc@med.showa-u.ac.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Kuwayama
Organization	Showa University
Division name	Department of Breast Surgical Oncology
Zip code	142-8666
Address	1-5-8, hatanodai, shinagawaku, Tokyo, japan
TEL	03-3784-85-8511
Homepage URL
Email	breastc@med.showa-u.ac.jp

Sponsor
Institute	Department of Breast Surgical Oncology, Showa University
Institute
Department

Funding Source
Organization	Japan Society of Clinical Oncology (Clinical Research Program Grant)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Bio-Ethical Committee,Showa University
Address	1-5-8, hatanodai, shinagawaku, Tokyo, japan
Tel	03-3784-8000
Email	mkyoumu@ofc.showa-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	昭和大学病院（東京都） 昭和大学藤が丘病院（東京都） 聖路加国際病院（東京都） 東京医科歯科大学（東京） 東京共済病院（東京） 虎ノ門病院（東京） 聖マリアンナ医科大学（神奈川）

Other administrative information
Date of disclosure of the study information	2011 Year 06 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	No longer recruiting
Date of protocol fixation	2011 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date	2011 Year 04 Month 01 Day
Last follow-up date	2014 Year 09 Month 01 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 04 Month 06 Day
Last modified on	2021 Year 04 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006397