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PD-L1 Inhibitor

Paclitaxel for Breast Cancer (IMpassion131 Trial)

Phase 3

Waitlist Available

Research Sponsored by Hoffmann-La Roche

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from objective response to pd, assessed up to primary completion date (approximately 26 months)

Awards & highlights

IMpassion131 Trial Summary

This trial is testing a new drug to see if it is effective and safe in treating people with a certain type of breast cancer.

Eligible Conditions

Breast Cancer

IMpassion131 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from objective response to pd, assessed up to primary completion date (approximately 26 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from objective response to pd, assessed up to primary completion date (approximately 26 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and from objective response to pd, assessed up to primary completion date (approximately 26 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Intent-to-Treat (ITT) Population

Progression-Free Survival (PFS) Assessed Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in the Subpopulation With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status

Secondary outcome measures

Duration of Confirmed Response (C-DoR) in (C-DoR)-Evaluable Population

Duration of Objective Response (DOR) Assessed Using RECIST v1.1 in DOR-evaluable Population (Unconfirmed)

Maximum Observed Plasma Concentration (Cmax) of Paclitaxel

+17 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Neurotoxicity

13%

Alanine aminotransferase increased

13%

Cough

13%

Vomting

Headache

Musculoskeletal pain

Aspartate aminotransferase increased

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

IMpassion131 Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Atezolizumab and PaclitaxelExperimental Treatment2 Interventions

Participants will receive atezolizumab at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg per square meter (mg/m^2) via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

Group II: Placebo and PaclitaxelPlacebo Group2 Interventions

Participants will receive placebo matching to atezolizumab via IV infusion on Days 1 and 15 (± 3 days) of every 28-day cycle along with paclitaxel administered at a dose of 90 mg/m^2 via IV infusion on Days 1, 8, and 15 of every 28-day cycle until disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab Placebo

2017

Completed Phase 3

~1960

Paclitaxel

2011

Completed Phase 4

~5380

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,431 Previous Clinical Trials

1,089,415 Total Patients Enrolled

160 Trials studying Breast Cancer

91,442 Patients Enrolled for Breast Cancer

Clinical TrialsStudy DirectorHoffmann-La Roche

2,201 Previous Clinical Trials

888,287 Total Patients Enrolled

138 Trials studying Breast Cancer

72,096 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are some of the cancer types that may be helped by paclitaxel?

"Paclitaxel can be used to treat aggressive bladder cancer that has spread, AIDS, and a form of cancer affecting the thymus."

Answered by AI

Has the FDA cleared Paclitaxel for public consumption?

"Paclitaxel has been given a safety rating of 3 by our team at Power. This is because Phase 3 trials, of which this is one, have supporting data for efficacy as well as multiple rounds of data affirming safety."

Answered by AI

What is the sample size of this clinical trial?

"This study is not currently enrolling patients. However, it was last updated on October 26th, 2022. There are 2436 and 1190 studies respectively searching for patients with triple negative breast neoplasms and Paclitaxel that are still recruiting participants."

Answered by AI

In how many different areas is this trial being conducted?

"The trial is being conducted in 17 different locations, which are situated in London, Stanford, Saint Petersburg and other cities. If you choose to participate in the clinical trial, it would be ideal to select a location near you to cut down on travel time and expenses."

Answered by AI

Is there any previous research on Paclitaxel?

"There are currently 1190 clinical trials studying the efficacy of Paclitaxel. Of those, 289 have reached Phase 3. The global study is being conducted in many locations, with the highest concentration 61608 sites based in Shanghai, China."

Answered by AI

Are there any positions available for potential participants in this research?

"This particular trial is no longer recruiting patients. However, interested parties can refer to the 2536 clinical trials actively searching for individuals with triple negative breast neoplasms and 1190 trials for Paclitaxel that are still looking for participants."

Answered by AI

Recent research and studies

Annals of OncologyJournal

Primary Results from Impassion131, a Double-blind, Placebo-controlled, Randomised Phase III Trial of First-line Paclitaxel with or Without Atezolizumab for Unresectable Locally Advanced/metastatic Triple-negative Breast Cancer

Miles, D., J. Gligorov, F. André, D. Cameron, A. Schneeweiss, C. Barrios, B. Xu, et al.. 2021. “Primary Results from Impassion131, a Double-blind, Placebo-controlled, Randomised Phase III Trial of First-line Paclitaxel with or Without Atezolizumab for Unresectable Locally Advanced/metastatic Triple-negative Breast Cancer”. Annals of Oncology. Elsevier BV. doi:10.1016/j.annonc.2021.05.801.

clinicaltrials.govStudy

A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)

2017. "A Study of Atezolizumab and Paclitaxel Versus Placebo and Paclitaxel in Participants With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer (TNBC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03125902.