UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028774
Receipt number R000032851
Scientific Title Meta-analysis of Abraxane used as a neo-adjuvant chemotherapy for operable breast cancer
Date of disclosure of the study information 2017/09/01
Last modified on 2021/07/02 10:08:44

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Basic information

Public title

Meta-analysis of Abraxane used as a neo-adjuvant chemotherapy for operable breast cancer

Acronym

JBCRG-S01

Scientific Title

Meta-analysis of Abraxane used as a neo-adjuvant chemotherapy for operable breast cancer

Scientific Title:Acronym

JBCRG-S01

Region

Japan Asia(except Japan)


Condition

Condition

Operable breast cancer(stage I-III)

Classification by specialty

Hematology and clinical oncology Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To investigate the average efficacy rate of Abraxane-containing regimen as a neoadjuvant chemotherapy for breast cancer in Japan based on the following two hypotheses.
For anthracycline and taxane containing regimen as a neoadjuvant chemotherapy, the following two hypotheses are set up.
1.Abraxane as taxane may show a high pCR rate in combination with trastuzumab for HER2-positive breast cancer.
2.Abraxane as taxane may be safe and tolerable for most of patients.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

pCR: pathological complete response

Key secondary outcomes

Adverse events(>=G3)
RDI(Relative dose intensity for Abraxane)


Base

Study type

Others,meta-analysis etc


Study design

Basic design


Randomization


Randomization unit


Blinding


Control


Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms


Purpose of intervention


Type of intervention


Interventions/Control_1


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


Not applicable

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1)Clinical trial(s) started after July 2010.
2)Principal investigator(s) in each trial agree with participation in this study.
3)Abraxane-containing regimen was used for neoadjuvant chemotherapy in naive operable breast cancer patients.
4)Registered in UMIN with ethical review.
5)Clinical trials in which more than 10 patients participated.
6)Clinical trials that have already been completed (unpublished data are available).
7)To submit the data, each researcher was authorized by each research ethics committee.

Key exclusion criteria

Patients who are unwilling to participate in this study.

Target sample size

500


Research contact person

Name of lead principal investigator

1st name 1.Manabu 2.Mari 3.Norikazu
Middle name
Last name 1.Futamura 2.Oba 3.Masuda

Organization

1. Gifu University Hospital
2. Toho University
3. National Hospital Organization Osaka Medical Center

Division name

1. Dept. of Surgical Oncology 2. Dept. of Medical Statistics Faculty of Medicine 3. Dept. of Surgery, Breast Oncology

Zip code

501-1194

Address

1) 1-1Yanagito Gifu, Gifu, Japan

TEL

058-230-6235

Email

mfutamur@gifu-u.ac.jp


Public contact

Name of contact person

1st name Jun
Middle name
Last name Fukase

Organization

Japan Breast Cancer Research Group (JBCRG)

Division name

Head office

Zip code

103-0016

Address

9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo, Japan

TEL

03-6264-8873

Homepage URL

https://www.jbcrg.jp/

Email

office@jbcrg.jp


Sponsor or person

Institute

Japan Breast Cancer Research Group (JBCRG)

Institute

Department

Personal name



Funding Source

Organization

TAIHO Pharmaceutical Co., Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

N/A

Address

N/A

Tel

N/A

Email

N/A


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

岐阜大学医学部附属病院(岐阜県)


Other administrative information

Date of disclosure of the study information

2017 Year 09 Month 01 Day


Related information

URL releasing protocol

https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1007/s12282-021-01238-9

Number of participants that the trial has enrolled

753

Results

Result
The overall crude frequencies of pCR (ypT0 ypN0, ypT0/is ypN0, and ypT0/is ypNX) were 18.1, 26.0, and 28.6%, respectively. Specifically, the frequencies were 6.7, 10.2, and 13.4% for luminal ; 40.5, 63.5, and 68.9% for HER2-rich ; 21.9, 40.6, and 42.7% for luminal/HER2 ; and 26.3, 31.5, and 32.3% for TNBC.

Conclusions
Nab-PTX is an acceptable chemotherapeutic agent for aggressive breast cancers such as HER2-rich, luminal/HER2, and TNBC subtypes in a neoadjuvant setting.

Results date posted

2021 Year 07 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2021 Year 04 Month 03 Day

Baseline Characteristics

Nab-PTX used as neoadjuvant chemotherapy for operable breast cancer based on individual patient data

Participant flow

Patients with operable BC (cStages I-III) who received NAC with nab-PTX were included.

Adverse events

The proportion of hematological toxicities (neutropenia (39.7%) and leukopenia (22.5%)), peripheral sensory neuropathy (9.7%), myalgia (5.7%), and arthralgia (4.7%) was higher than grade 3 adverse events.

Outcome measures

The primary endpoint was pathological complete response (pCR) rate of each breast cancer
subtype.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 10 Month 01 Day

Date of IRB

2017 Year 11 Month 01 Day

Anticipated trial start date

2017 Year 10 Month 15 Day

Last follow-up date

2019 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Backgraund:
1.Classification of sex
2.Age
3.Menopausal Status
4.Performance Status

Stage:
TNM Classification

Histopathological Finding:
1.Histological Type
2.Hormonal Receptor(ER/PgR)
3.HER2(IHC, FISH/DISH)
4.Histological/Nuclear Grade
5.Ki-67 labelling index
6.Clinical Stage

Neoadjuvant Chemotherapy:
1.Chemotherapy regimen(Abraxane is mandatory)
2.Trastuzumab(does, duration)
3.Administered Cycle/dose of chemotherapy
4.Adverse events(>=G3)
5.Clinical outcome due to RECIST

Operation:
1.Pathological stage
2.Histological grade
3.Status of axillary lymph node metastasis
4.Hormonal Receptor(ER/PgR)
5.HER2(IHC, FISH/DISH)
6.Ki67
7.pCR(ypT0ypN0, ypT0/isypN0, ypT0/isypNX)


Management information

Registered date

2017 Year 08 Month 22 Day

Last modified on

2021 Year 07 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032851


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name