UMIN-CTR Clinical Trial

Public title

Hormonal therapy resistant estorgen receptor positive metastatic breast cancer cohort study

Acronym

HORSE-BC

Scientific Title

Hormonal therapy resistant estorgen receptor positive metastatic breast cancer cohort study

Scientific Title:Acronym

HORSE-BC

Region

Japan

Condition

Breast cancer

Classification by specialty

Hematology and clinical oncology

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

(1)To demonstrate the efficacy and safety of secondary endocrine therapy in general as well as that of different drugs in estrogen receptor-positive, HER2-negative postmenopausal metastatic breast cancer in which the primary endocrine therapy did not have a favorable clinical effect (i.e., low sensitivity to primary endocrine therapy).

(2)To clarify the effects of reactivity to the previous endocrine therapy (the period from the start of postoperative endocrine therapy to recurrence) and the biological characteristics of each tumor (expression intensity of ER and presence or absence of PgR expression) on the results of the secondary endocrine therapy, and to obtain information to complement Hortobagyi's therapeutic algorithm.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable

Primary outcomes

Clinical benefit rate

Key secondary outcomes

Progression free survival
overall survival
time to treatment failure
time to chemotherapy
response rate
health-related quality of life
adverse events

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Cases that satisfy all of the following conditions are included in this study as subjects.
(1) A patient with estrogen receptor positive postmenopausal breast cancer who is histologically diagnosed as breast cancer.

(2) Diagnosis of breast cancer corresponds to either of the following. No distinction is made according to the presence or absence of measurable lesions.
1. Stage 4 breast cancer associated with distant metastasis that cannot be a candidate for surgery at the first visit.
2. Breast cancer associated with progression or recurrence caused by distant metastasis after initial treatment for breast cancer aiming at curing.

(3) Endocrine therapy for metastatic breast cancer is planned.

(4) Performance status of ECOG is 0 or 1.

(5) Previous endocrine therapy for breast cancer corresponds to either of the following. No distinction is made according to the type of endocrine therapeutic medicines used.
1. A case that has continuously received endocrine therapeutic medicines as a postoperative adjunct therapy and in which recurrence occurred within 5 years after the initiation of the endocrine therapy.

2. A case that received endocrine therapy as the primary treatment for metastatic breast cancer and in which progression of the disease occurred within 9 months after the initiation of the endocrine therapy.

(6) Previous chemotherapy for breast cancer corresponds to either of the following:
1. No previous chemotherapy was administered.
2. When chemotherapy was administered as a preoperative or postoperative adjunct therapy, it has been at least 6 months since the final day of administration.

(7) Previous radiotherapy for breast cancer corresponds to the following:
1. It has been at least 14 days after the final day of radiotherapy administration.

(8)Agreement about the participation in the study will be obtained from the subject him/herself using the consent form.

Key exclusion criteria

A case that corresponds to any of the following is excluded from participating in this study as a subject.
(1)HER2-positive breast cancer.

(2)A case not indicated for endocrine therapy.

(3)Any other case that a physician determines to be unsuitable for participation in this study.

Target sample size

200

Name of lead principal investigator

1st name
Middle name
Last name	Naruto Taira

Organization

Okayama university hospital

Division name

breast and endocrine surgery

Zip code

Address

Shikata-cho 2-5-1, Kita-ku, Okayama city

TEL

086-235-7265

Email

ntaira@md.okayama-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Tomomi Fujisawa

Organization

Gunma Prefectural Cancer Center

Division name

Breast oncology

Zip code

Address

617-1 Takahayashinishicho, Ota, Gunma,

TEL

0276-38-077

Homepage URL

Email

fujisawa@gunma-cc.jp

Institute

General Incorporated Association of CSPOR-BC

Institute

Department

Personal name

Organization

Research funds from the Investigator Initiated-Sponsored Research of the Externally Sponsored Research program of AstraZeneca K.K..

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2015

Year

11

Month

01

Day

URL releasing protocol

http://cspor-bc.or.jp/members/horse-bc/index.html

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2015

Year

08

Month

12

Day

Date of IRB

2015

Year

11

Month

26

Day

Anticipated trial start date

2016

Year

02

Month

22

Day

Last follow-up date

2019

Year

02

Month

22

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study aims to clarify the efficacy and safety of secondary endocrine therapy using endocrine therapeutic medicines in estrogen receptor-positive, HER2-negative postmenopausal metastatic breast cancer for which the primary endocrine therapy had no favorable clinical effect through prospective observation using outcome indices including the clinical benefit rate, progression free survival, overall survival, time to treatment failure, time to chemotherapy, response rate, health-related quality of life, and adverse events.
Secondary aims include to categorize the wide variety of endocrine therapeutic medicines that are currently usable in Japan based on their action mechanisms and to evaluate their efficacy and safety.

Registered date

2015

Year

10

Month

29

Day

Last modified on

2020

Year

05

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022616