UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015168
Receipt number R000017287
Scientific Title Investigation of optimal regimen of Fulvestrant in patients with postmenopausal ER-positive advanced recurrent breast cancer
Date of disclosure of the study information 2014/09/16
Last modified on 2021/08/06 08:24:51

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Investigation of optimal regimen of Fulvestrant in patients with postmenopausal ER-positive advanced recurrent breast cancer

Acronym

JBCRG-C06

Scientific Title

Investigation of optimal regimen of Fulvestrant in patients with postmenopausal ER-positive advanced recurrent breast cancer

Scientific Title:Acronym

JBCRG-C06

Region

Japan


Condition

Condition

Patients with postmenopausal ER-positive advanced recurrent breast cancer

Classification by specialty

Hematology and clinical oncology Surgery in general Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to retrospectively evaluate effects of subject's clinical background and prior therapies on the treatment time with Fulvestrant(TTF), in patients with postmenopousal ER-positive advanced recurrent breast cancer receiving Fulvestrant in clinical setting in Japan. Also this study is to explore the impact on prognosis for advanced recurrent breast cancer receiving Fulvestrant as a secondary analysis.
In the explanatory analysis study, JBCRG-C06-A1 (MPA analysis), using the data accumulated in C06, the TTF (treatment success period) of MPA is clarified as real world data, and factors affecting TTF in patients using MPA in the third and subsequent treatments are investigated.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Effects of clinical background and prior therapies on the treatment time with Fulvestrant (TTF)

Key secondary outcomes

Secondary analysis
1.Effects of clinical background and prior therapies on overall survival (OS) after start of Fulvestrant
2.Descriptive statistics of treatment
3.Summary of therapies administered to subjects with long survival
In the explanatory analysis study JBCRG-C06-A1 (MPA analysis), the treatment success period of MPA by treatment line (TTF), the number of endocrine therapy treatment lines for progression recurrence of MPA, and patient factors for TTF of MPA are evaluated.


Base

Study type

Observational


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) Patients with postmenopausal ER-positive advanced recurrent breast cancer after prior hormone therapy
2) Register the patients that start to use Fulvestrant between November, 2011 (after release of Fulvestrant) and December 31, 2014 in a real clinical treatment

Key exclusion criteria

1)Patients not agree with this study

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name C061)Hidetoshi 2)Shinji C06-A11)Hidetoshi 2)Yutaka
Middle name
Last name JBCRG-C06 1)Kawaguchi 2)Ohno JBCRG-C06-A1 1)Kawaguchi 2)Yamamoto

Organization

JBCRG-C06 1) Matsuyama Red Cross Hospital
2) The Cancer Institute Hospital Of JFCR
JBCRG-C06-A1 1) Matsuyama Red Cross Hospital 2) Kumamoto University, Graduate School of Medical Sciences

Division name

JBCRG-C06 1) Department of breast surgery 2) Breast Oncology Center JBCRG-C06-A1 1) Department of breast surgery 2) Department of breast and endocrine surgery

Zip code

790-8524

Address

1) 1 Bunkyo-cho , Matsuyama-shi, Ehime Japan

TEL

089-924-1111

Email

hkawaguchi@matsuyama.jrc.or.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://jbcrg.jp/

Email

office@jbcrg.jp


Sponsor or person

Institute

Japan Breast Cancer Research Group(JBCRG)

Institute

Department

Personal name



Funding Source

Organization

AstraZeneca K.K.(JBCRG-C06)

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)

Department of Breast and Endocrine Surgery, Graduate School of Life Sciences, Kumamoto University (JBCRG-C06,JBCRG-C06-A1)


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

松山赤十字病院(愛媛県)、国立病院機構 九州がんセンター(福岡県)、弘前市立病院(青森県)、新潟県立がんセンター新潟病院(新潟県)、久留米総合病院(福岡県)、広島市民病院(広島県)、愛知県がんセンター中央病院(愛知県)、相良病院(鹿児島県)、北海道大学病院(北海道)、群馬県立がんセンター(群馬県)、昭和大学病院(東京都)、四国がんセンター(愛媛県)、北九州市立医療センター(福岡県)、がん研究会有明病院(東京都)、虎の門病院(東京都)、熊本大学医学部附属病院(熊本県)


Other administrative information

Date of disclosure of the study information

2014 Year 09 Month 16 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/10.1080/03007995.2017.1400426

Number of participants that the trial has enrolled

1072

Results

1031 patients (96.2%) were evaluable for efficacy. F500 was administered as 1st-line treatment in 2.0%, 2nd-line in 22.7%, 3rd-line in 26.7%, and >=4th-line in 48.6% patients. Median TTF was 5.4 months. Multivariate analysis found that earlier F500 use (1st and 2nd vs. 3rd vs.>=4th line; P<0.001), longer period from AMBC diagnosis to F500 use (>=3 vs.<3 years; P<.001), and no prior palliative chemotherapy administered for unresectable or MBC (no vs. yes; P<.001) was associated with significantly longer TTF.

Results date posted

2021 Year 08 Month 06 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results

2017 Year 11 Month 03 Day

Baseline Characteristics

Postmenopausal patients with ER-positive advanced recurrent breast cancer

Participant flow

1072 patients were registered that started to use Fulvestrant between November,2011 (after release of Fulvestrant) and December 31, 2014 in a real clinical treatment.

Adverse events

Three patients (0.3%) experienced grade 3 (CTCAE v.1.1) AEs including injection site infection (n = 1), lower-extremity peripheral neuropathy (n = 1).

Outcome measures

The endpoint of this study was to evaluate the effect of clinical background and treatment line of F500 on TTF using multivariate analysis.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Main results already published

Date of protocol fixation

2014 Year 07 Month 30 Day

Date of IRB

2013 Year 08 Month 08 Day

Anticipated trial start date

2014 Year 10 Month 01 Day

Last follow-up date

2018 Year 04 Month 30 Day

Date of closure to data entry

2018 Year 06 Month 30 Day

Date trial data considered complete

2018 Year 06 Month 30 Day

Date analysis concluded



Other

Other related information

This study is a retrospective observational study to investigate clinical experience of Fulvestrant. The study does not involve study-specific intervention such as treatments or tests because it is designed as an observational study. Instead, data obtained from daily practice is surveyed. Treatment method is selected for each subject by the attending physician and the subject herself.


Management information

Registered date

2014 Year 09 Month 16 Day

Last modified on

2021 Year 08 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017287


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name