UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019556 |
|---|---|
| Receipt number | R000022616 |
| Scientific Title | Hormonal therapy resistant estorgen receptor positive metastatic breast cancer cohort study |
| Date of disclosure of the study information | 2015/11/01 |
| Last modified on | 2020/05/11 12:20:19 |
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Basic information
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
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
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
Assessment
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
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
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
Research contact person
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
ntaira@md.okayama-u.ac.jp
Public contact
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
fujisawa@gunma-cc.jp
Sponsor or person
Institute
General Incorporated Association of CSPOR-BC
Institute
Department
Personal name
Funding Source
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
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
http://cspor-bc.or.jp/members/horse-bc/index.html
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
| 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
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.
Management information
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
