Clinical Trials

ALEXANDRA/IMpassion030
GLOBAL ALEXANDRA/IMpassion030

A PHASE III, MULTICENTER, RANDOMIZED, OPEN-LABEL STUDY COMPARING ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) IN COMBINATION WITH ADJUVANT ANTHRACYCLINE/TAXANEBASED CHEMOTHERAPY VERSUS CHEMOTHERAPY ALONE IN PATIENTS WITH OPERABLE TRIPLE-NEGATIVE BREAST CANCER

Status
Study Closed

Objectives
1. Compare and evaluate effectiveness for TNBC patients with Atezolizumab as postoperative therapy + T-AC / EC vs T-AC / EC only
2. Evaluate the effectiveness of AtezoliZumab as adjuvant therapy + T–AC/EC vs T–AC/EC only

Subjects

Endpoints
iDFS, OS, RFI, DRFI, DFS,

Trial Period
Aug 2018 - 7years after final randomization

Lead Principal Investigator
(Japan) Dr. Shigehira Saji (Fukushima Medical Univ)

Target Sample Size
(Global) 2300, (Japan) 200

Regimen
Atezolizmab(RO5541267)

Source of Funding
BIG, F. Hoffman-La Roche Ltd. , Chugai

Conference Presentation

Articles and Publications

UMIN-ID
EUDRACT no:2016-003695-47

jRCT

Memo

COI Disclosure

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