UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010228
Receipt number R000011975
Scientific Title Neoadjuvant chemotherapy with Paclitaxel/Bevacizumab followed by FEC (5-Fluorouracil/Epirubicin/Cyclophosphamide) for triple negative operable primary breast cancer
Date of disclosure of the study information 2013/03/13
Last modified on 2018/08/03 11:07:45

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Basic information

Public title

Neoadjuvant chemotherapy with Paclitaxel/Bevacizumab followed by FEC (5-Fluorouracil/Epirubicin/Cyclophosphamide) for triple negative operable primary breast cancer

Acronym

Neoadjuvant Paclitaxel/Bevacizumab followed by FEC therapy for triple negative breast cancer

Scientific Title

Neoadjuvant chemotherapy with Paclitaxel/Bevacizumab followed by FEC (5-Fluorouracil/Epirubicin/Cyclophosphamide) for triple negative operable primary breast cancer

Scientific Title:Acronym

Neoadjuvant Paclitaxel/Bevacizumab followed by FEC therapy for triple negative breast cancer

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Response rate

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

Response rate

Key secondary outcomes

Pathological complete response rate, Breast-conserving rate, Overall Survival, Relapse-free survival, Safety


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

Neoadjuvant Paclitaxel/Bevacizumab followed by FEC (5-Fluorouracil/Epirubicin/Cyclophosphamide)

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

75 years-old >

Gender

Female

Key inclusion criteria

1) invasive breast cancer by needle biopsy
2) operable primary breast cancer (cStage I~IIIA)
3) ER(-), PgR(-)
4) HER2 negative (IHC 0, 1+ or FISH -)
5) P.S. = 0~1
6) measurable lesions
7) preserving the functions of bone marrow, heart, liver, and kidney
8) written informed consent

Key exclusion criteria

1) drug allergy
2) severe complications (malignant hypertension, congestive heart failure, coronary heart disease, myocardial infarction (onset within 6 months), arrhythmia (treated), infectious disease, bleeding tendency, etc)
3) feber, infection
4) peripheral neuropathy
5) pleural effusion, pericardial effusion
6) active double cancer
7) inflammatory breast cancer
8) male breast cancer
9) pregnancy
10) severe edema
11) interstitial pneumonia, fibrous lung disease
12) steroid-using patients
13) psychosomatic disease
14) active digestive ulcer
15) unsuitable patients

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Koichiro Tsugawa, M.D.

Organization

St. Marianna University School of Medicine

Division name

Department of Surgery, Division of Breast and Endocrine Surgery

Zip code


Address

2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, Japan

TEL

044-977-8111

Email

koitsuga@marianna-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Koiciro Tsugawa

Organization

St. Marianna University School of Medicine

Division name

Department of Surgery, Division of Breast and Endocrine Surgery

Zip code


Address

2-16-1, Sugao, Miyamae-ku, Kawasaki-city, Kanagawa, Japan

TEL

044-977-8111

Homepage URL


Email

koitsuga@marianna-u.ac.jp


Sponsor or person

Institute

Department of Surgery, Division of Breast and Endocrine Surgery, St. Marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Surgery, Division of Breast and Endocrine Surgery, St. Marianna University School of Medicine

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


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



Other administrative information

Date of disclosure of the study information

2013 Year 03 Month 13 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

2012 Year 10 Month 18 Day

Date of IRB


Anticipated trial start date

2013 Year 03 Month 13 Day

Last follow-up date

2014 Year 12 Month 31 Day

Date of closure to data entry

2015 Year 01 Month 31 Day

Date trial data considered complete

2015 Year 02 Month 28 Day

Date analysis concluded

2015 Year 03 Month 31 Day


Other

Other related information



Management information

Registered date

2013 Year 03 Month 13 Day

Last modified on

2018 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011975


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name