Unique ID issued by UMIN | UMIN000043917 |
---|---|
Receipt number | R000050098 |
Scientific Title | Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer |
Date of disclosure of the study information | 2021/04/14 |
Last modified on | 2021/04/14 07:35:40 |
Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer
Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer
Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer
Observational study investigating the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer
Japan |
Breast cancer
Breast surgery |
Malignancy
NO
To evaluate the efficacy and safety of fulvestrant + CDK4 / 6 inhibitor as a primary endocrine therapy for hormone receptor-positive, HER2-negative advanced/metastatic breast cancer
Safety,Efficacy
Progression free survival
1)Time to treatment failure
2)Overall survival
3)Objective response rate
4)Clinical benefit rate
5)Parcentage of participants with over Grade 3 adverse events
Observational
20 | years-old | <= |
Not applicable |
Female
Hormone receptor-positive, HER2-negative advanced/metastatic breast cancer patients who have completed postoperative hormone therapy for more than 1 year or who have not been treated with hormone therapy and who meet all of the following criteria are included.
1) Histologically confirmed advanced/metastatic breast cancer
2) Premenopausal or postmenopausal patients aged 20 years or older
3) Confirmed diagnosis of ER positive breast cancer
4) Confirmed diagnosis of HER2 negative breast cancer
5) Adequate organ and bone marrow function
6) Easter Cooperative Oncology Group [ECOG]0-1
7) No prior systemic chemotherapy or 1st line prior systemic chemotherapy
8) Signed written informed consent
1) Recurrence during postoperative hormone therapy or within 1 year from completion of treatment
2) Known uncontrolled or symptomatic central nervous system metastases
3) Patients with advanced symptomatic visceral spread that are at risk of life threatening complication in the short term
4) Prior endocrine therapy for advanced/metastatic breast cancer
5) Known interstitial lung disease on imaging
6) Known uncontrolled infection
7) Current pregnancy and lactation or possibility of pregnancy
8) Known drug allergy to any of study drugs
9) Assessment by investigator that subject unable to comply with protocol
30
1st name | Yutaka |
Middle name | |
Last name | Mizuno |
Yokkaichi Municipal Hospital
Breast Surgery
510-8567
2-2-37 Shibata Yokkaichi-city Mie
059-354-1111
mizunoy729@yokkaichihp01.jp
1st name | Yutaka |
Middle name | |
Last name | Mizuno |
Yokkaichi Municipal Hospital
Breast Surgery
510-8567
2-2-37 Shibata Yokkaichi-city Mie
059-354-1111
mizunoy729@yokkaichihp01.jp
Breast Surgery, Yokkaichi Municipal Hospital
Breast Surgery, Yokkaichi Municipal Hospital
Other
Institutional Review Board, Yokkaichi Municipal Hospital
2-2-37 Shibata Yokkaichi-city Mie
059-354-1111
chiken@yokkaichihp01.jp
NO
2021 | Year | 04 | Month | 14 | Day |
Unpublished
Open public recruiting
2021 | Year | 03 | Month | 01 | Day |
2021 | Year | 03 | Month | 22 | Day |
2021 | Year | 04 | Month | 01 | Day |
2026 | Year | 12 | Month | 31 | Day |
Observational study
2021 | Year | 04 | Month | 14 | Day |
2021 | Year | 04 | Month | 14 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050098
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |