UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000023112
Receipt number R000026421
Scientific Title Surveillance of menstrual patterns and adverse effect for LH-RH agonist therapy in premenopausal hormone receptor-positive breast cancer patients
Date of disclosure of the study information 2016/07/12
Last modified on 2018/07/13 12:37:07

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Basic information

Public title

Surveillance of menstrual patterns and adverse effect for LH-RH agonist therapy in premenopausal hormone receptor-positive breast cancer patients

Acronym

Surveillance of menstrual patterns and adverse effect for LH-RH agonist therapy in premenopausal hormone receptor-positive breast cancer patients

Scientific Title

Surveillance of menstrual patterns and adverse effect for LH-RH agonist therapy in premenopausal hormone receptor-positive breast cancer patients

Scientific Title:Acronym

Surveillance of menstrual patterns and adverse effect for LH-RH agonist therapy in premenopausal hormone receptor-positive breast cancer patients

Region

Japan


Condition

Condition

breast cancer

Classification by specialty

Breast surgery

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

Reveal the side effects and QOL after the start of endocrine treatment for pre-menopausal breast cancer patients

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

side effect of the incidence of post-dose after 3 months and QOL

Key secondary outcomes



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

20 years-old <=

Age-upper limit


Not applicable

Gender

Female

Key inclusion criteria

1. premenopausal women
2. Breast cancer patients with hormone receptor-positive
3. Patients scheduled to administer the LH-RH agonist
4. Preoperative or postoperative hormone receptor-positive patient , hormone receptor-positive patients with no prior treatment as metastatic or recurrent treatment

Key exclusion criteria

1. Patients undergoing total hysterectomy surgery of the uterus
2. Patients registration to this study is deemed difficult due to mental disorders clinically relevant

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yasunori Miyamoto

Organization

Hamamatsu Medical Center

Division name

Division of Pharmacy

Zip code


Address

Tomidzuka-cho 328 Nakaku Hamamatsu Shizuoka

TEL

053-453-7111

Email

ymiyamo@hmedc.or.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasunori Miyamoto

Organization

Hamamatsu Medical Center

Division name

Division of Pharmacy

Zip code


Address

Tomidzuka-cho 328 Nakaku Hamamatsu Shizuoka

TEL

053-453-7111

Homepage URL


Email

ymiyamo@hmedc.or.jp


Sponsor or person

Institute

Hamamatsu Medical Center, Division of Pharmacy

Institute

Department

Personal name



Funding Source

Organization

Hamamatsu Medical Center, Division of Pharmacy

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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

浜松医療センター(静岡県)


Other administrative information

Date of disclosure of the study information

2016 Year 07 Month 12 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

2016 Year 06 Month 15 Day

Date of IRB


Anticipated trial start date

2016 Year 07 Month 12 Day

Last follow-up date

2018 Year 06 Month 30 Day

Date of closure to data entry

2018 Year 06 Month 30 Day

Date trial data considered complete


Date analysis concluded



Other

Other related information

To assess the situation and QOL of side effects on patients who meet the selection criteria


Management information

Registered date

2016 Year 07 Month 11 Day

Last modified on

2018 Year 07 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026421


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name