Clinical Trials

JBCRG-S01

Meta-analysis of Abraxane used as a neo-adjuvant chemotherapy for operable breast cancer  

Status
Study Closed

Objectives
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.

Subjects

Endpoints
Primary: pCR: pathological complete response
Secondary: Adverse events(>=G3) , RDI(Relative dose intensity for Abraxane)

Trial Period
Nov. 2017~Jan. 2019

Lead Principal Investigator
1.Manabu Futamura(Gifu University Hospital ) 2.Mari Oba(Toho University) 3.Norikazu Masuda(National Hospital Organization Osaka Medical Center )

Target Sample Size

Regimen
Abraxane

Source of Funding
TAIHO Pharmaceutical Co., Ltd 

Conference Presentation
Meta-analysis of nanoparticle albumin-bound paclitaxel (Nab-PTX) used as a neoadjuvant chemotherapy for operable breast cancer based on individual patient data (JBCRG-S01)

Articles and Publications
Meta‑analysis of nanoparticle albumin‑bound paclitaxel used as neoadjuvant chemotherapy for operable breast cancer based on individual patient data (JBCRG‑S01 study)

UMIN-ID
UMIN000028774

jRCT

Memo

COI Disclosure

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