Unique ID issued by UMIN | UMIN000028774 |
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Receipt number | R000032851 |
Scientific Title | Meta-analysis of Abraxane used as a neo-adjuvant chemotherapy for operable breast cancer |
Date of disclosure of the study information | 2017/09/01 |
Last modified on | 2021/07/02 10:08:44 |
Meta-analysis of Abraxane used as a neo-adjuvant chemotherapy for operable breast cancer
JBCRG-S01
Meta-analysis of Abraxane used as a neo-adjuvant chemotherapy for operable breast cancer
JBCRG-S01
Japan | Asia(except Japan) |
Operable breast cancer(stage I-III)
Hematology and clinical oncology | Breast surgery |
Malignancy
NO
To investigate the average efficacy rate of Abraxane-containing regimen as a neoadjuvant chemotherapy for breast cancer in Japan based on the following two hypotheses.
For anthracycline and taxane containing regimen as a neoadjuvant chemotherapy, the following two hypotheses are set up.
1.Abraxane as taxane may show a high pCR rate in combination with trastuzumab for HER2-positive breast cancer.
2.Abraxane as taxane may be safe and tolerable for most of patients.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
pCR: pathological complete response
Adverse events(>=G3)
RDI(Relative dose intensity for Abraxane)
Others,meta-analysis etc
Not applicable |
Not applicable |
Female
1)Clinical trial(s) started after July 2010.
2)Principal investigator(s) in each trial agree with participation in this study.
3)Abraxane-containing regimen was used for neoadjuvant chemotherapy in naive operable breast cancer patients.
4)Registered in UMIN with ethical review.
5)Clinical trials in which more than 10 patients participated.
6)Clinical trials that have already been completed (unpublished data are available).
7)To submit the data, each researcher was authorized by each research ethics committee.
Patients who are unwilling to participate in this study.
500
1st name | 1.Manabu 2.Mari 3.Norikazu |
Middle name | |
Last name | 1.Futamura 2.Oba 3.Masuda |
1. Gifu University Hospital
2. Toho University
3. National Hospital Organization Osaka Medical Center
1. Dept. of Surgical Oncology 2. Dept. of Medical Statistics Faculty of Medicine 3. Dept. of Surgery, Breast Oncology
501-1194
1) 1-1Yanagito Gifu, Gifu, Japan
058-230-6235
mfutamur@gifu-u.ac.jp
1st name | Jun |
Middle name | |
Last name | Fukase |
Japan Breast Cancer Research Group (JBCRG)
Head office
103-0016
9-4-3F, Nihonbashikoamicho, Chuo-ku, Tokyo, Japan
03-6264-8873
https://www.jbcrg.jp/
office@jbcrg.jp
Japan Breast Cancer Research Group (JBCRG)
TAIHO Pharmaceutical Co., Ltd
Profit organization
Japan
N/A
N/A
N/A
N/A
NO
岐阜大学医学部附属病院(岐阜県)
2017 | Year | 09 | Month | 01 | Day |
https://upload.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f5.cgi
Published
https://doi.org/10.1007/s12282-021-01238-9
753
Result
The overall crude frequencies of pCR (ypT0 ypN0, ypT0/is ypN0, and ypT0/is ypNX) were 18.1, 26.0, and 28.6%, respectively. Specifically, the frequencies were 6.7, 10.2, and 13.4% for luminal ; 40.5, 63.5, and 68.9% for HER2-rich ; 21.9, 40.6, and 42.7% for luminal/HER2 ; and 26.3, 31.5, and 32.3% for TNBC.
Conclusions
Nab-PTX is an acceptable chemotherapeutic agent for aggressive breast cancers such as HER2-rich, luminal/HER2, and TNBC subtypes in a neoadjuvant setting.
2021 | Year | 07 | Month | 02 | Day |
2021 | Year | 04 | Month | 03 | Day |
Nab-PTX used as neoadjuvant chemotherapy for operable breast cancer based on individual patient data
Patients with operable BC (cStages I-III) who received NAC with nab-PTX were included.
The proportion of hematological toxicities (neutropenia (39.7%) and leukopenia (22.5%)), peripheral sensory neuropathy (9.7%), myalgia (5.7%), and arthralgia (4.7%) was higher than grade 3 adverse events.
The primary endpoint was pathological complete response (pCR) rate of each breast cancer
subtype.
Completed
2017 | Year | 10 | Month | 01 | Day |
2017 | Year | 11 | Month | 01 | Day |
2017 | Year | 10 | Month | 15 | Day |
2019 | Year | 12 | Month | 31 | Day |
Backgraund:
1.Classification of sex
2.Age
3.Menopausal Status
4.Performance Status
Stage:
TNM Classification
Histopathological Finding:
1.Histological Type
2.Hormonal Receptor(ER/PgR)
3.HER2(IHC, FISH/DISH)
4.Histological/Nuclear Grade
5.Ki-67 labelling index
6.Clinical Stage
Neoadjuvant Chemotherapy:
1.Chemotherapy regimen(Abraxane is mandatory)
2.Trastuzumab(does, duration)
3.Administered Cycle/dose of chemotherapy
4.Adverse events(>=G3)
5.Clinical outcome due to RECIST
Operation:
1.Pathological stage
2.Histological grade
3.Status of axillary lymph node metastasis
4.Hormonal Receptor(ER/PgR)
5.HER2(IHC, FISH/DISH)
6.Ki67
7.pCR(ypT0ypN0, ypT0/isypN0, ypT0/isypNX)
2017 | Year | 08 | Month | 22 | Day |
2021 | Year | 07 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032851
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