Unique ID issued by UMIN | UMIN000035863 |
---|---|
Receipt number | R000040855 |
Scientific Title | Prospective Cohort Study of Palbociclib for Postmenopausal Metastatic Breast Cancer |
Date of disclosure of the study information | 2019/02/20 |
Last modified on | 2024/02/01 11:45:36 |
Prospective Cohort Study of Palbociclib for Postmenopausal Metastatic Breast Cancer
Palbociclib Cohort Study
Prospective Cohort Study of Palbociclib for Postmenopausal Metastatic Breast Cancer
Palbociclib Cohort Study
Japan |
postmenopausal patients with unresectable and metastatic hormone receptor-positive breast cancer,
Breast surgery |
Malignancy
NO
This study aims 1) to determine the efficacy and safety of palbociclib treatment as a daily clinical therapy in postmenopausal patients with unresectable and metastatic hormone receptor-positive breast cancer, and 2) to evaluate the effects of palbociclib treatment on the subsequent treatment that the research subjects will receive in Japan.
Efficacy
progression-free survival (PFS) in each treatment line.
1) overall survival,
2) clinical benefit rate (CBR)
3) AEs
4) patient-reported outcomes of the common terminology criteria for adverse events (PRO-CTCAE)
5) PFS
6) CBR with the next treatment
7) AEs caused by the subsequent treatment,
8) PRO-CTCAE with the subsequent treatment
9) reasons for selecting the treatment.
Observational
Not applicable |
Not applicable |
Female
Postmenopausal patients with ER-positive
Patients who is not adopt endocrine therapy.
700
1st name | Takashi |
Middle name | |
Last name | Ishikawa |
Tokyo Medical University Hospital
breast surgery
160-0023
6-7-1 Nishishinjyuku, Shinjyukuku, Tokyo
03-3342-6111
tsihik55@gmail.com
1st name | Takashi |
Middle name | |
Last name | Ishikawa |
Tokyo Medical University Hospital
Breast surgery
160-0023
6-7-1 Nishishinjyuku, Shinjyukuku, Tokyo
03-3342-6111
tsihik55@gmail.com
CSPOR-BC
CSPOR-BC
Non profit foundation
Tokyo Medical University Hospital
6-7-1 Nishishinjyuku, Shinjyukuku, Tokyo
03-3342-6111
tsihik55@gmail.com
NO
2019 | Year | 02 | Month | 20 | Day |
Unpublished
Completed
2018 | Year | 10 | Month | 03 | Day |
2019 | Year | 01 | Month | 17 | Day |
2019 | Year | 02 | Month | 18 | Day |
2024 | Year | 01 | Month | 31 | Day |
Observational study
2019 | Year | 02 | Month | 13 | Day |
2024 | Year | 02 | Month | 01 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040855
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |