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Monoclonal Antibodies

Tiragolumab for Breast Cancer

Phase 1

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 up to approximately 21 months

Awards & highlights

Study Summary

This trial is testing a new cancer treatment involving two drugs and chemotherapy to see if it is effective and safe for people with metastatic and early-stage triple-negative breast cancer.

Eligible Conditions

Breast Cancer

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 21 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 21 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 21 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

Confirmed Objective Response Rate ORR (Cohort A)

Percentage of Participants With Adverse Events (Cohort B)

Secondary outcome measures

Duration of Response (Cohort A)

Overall Survival (Cohort A)

Percentage of Participants With ADAs to Atezolizumab

+9 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Cohort B: Tiragolumab and Atezolizumab + Nab-pac-carbo-ACExperimental Treatment8 Interventions

Participants with early TNBC in the neoadjuvant setting, who are eligible for surgery, will receive tiragolumab and atezolizumab every 2 weeks (Q2W) in combination with nab-paclitaxel weekly (QW) and carboplatin every 3 weeks (Q3W) for four cycles, followed by tiragolumab and atezolizumab in combination with doxorubicin and cyclophosphamide Q2W with granulocyte colony-stimulating factor (G-CSF; filgrastim or pegfilgrastim) or granulocyte-macrophage colony-stimulating factor (GM-CSF) support for four doses.

Group II: Cohort B: Tiragolumab and Atezolizumab + Nab-pac-ACExperimental Treatment7 Interventions

Participantswith early TNBC in the neoadjuvant setting, who are eligible for surgery, will receive tiragolumab and atezolizumab Q2W in combination with nab-paclitaxel QW for 12 weeks, followed by tiragolumab and atezolizumab in combination with doxorubicin and cyclophosphamide Q2W with G-CSF (filgrastim or pegfilgrastim) or GM-CSF support for four doses.

Group III: Cohort A: Tiragolumab and Atezolizumab + Nab-paclitaxelExperimental Treatment3 Interventions

Participants with first-line metastatic TNBC will receive tiragolumab and atezolizumab on Day 1 of every 28-day cycle plus nab-paclitaxel on Days 1, 8, and 15 of every 28-day cycle.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Doxorubicin

2012

Completed Phase 3

~7940

Cyclophosphamide

1995

Completed Phase 3

~3770

Tiragolumab

2020

Completed Phase 2

~460

Atezolizumab

2017

Completed Phase 3

~5860

Nab-paclitaxel

2014

Completed Phase 3

~2030

Carboplatin

2014

Completed Phase 3

~6670

Granulocyte-macrophage colony-stimulating factor (GM-CSF)

2020

Completed Phase 1

~90

Granulocyte colony-stimulating factor (G-CSF)

2004

Completed Phase 3

~620

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor

2,432 Previous Clinical Trials

1,089,803 Total Patients Enrolled

160 Trials studying Breast Cancer

91,442 Patients Enrolled for Breast Cancer

Clinical TrialStudy DirectorHoffmann-La Roche

9 Previous Clinical Trials

2,187 Total Patients Enrolled

Frequently Asked Questions

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

To what medical ailments is Tiragolumab typically prescribed?

"Tiragolumab is used to treat acute lymphoblastic leukemia (ALL) and has also been found to effectively manage neoplasm metastasis, metastatic ureter urothelial carcinoma, lymphomas, and non-Hodgkin's."

Answered by AI

What other clinical explorations have been carried out regarding Tiragolumab?

"Tiragolumab was initially investigated in 1997 at the Spectrum Health Hospital - Butterworth Campus. In total, 3167 clinical experiments have been completed and 2324 are still enlisting participants with a large quantity of them held in Chicago, Illinois."

Answered by AI

Has Tiragolumab been granted authorization from the Food and Drug Administration?

"Our analysts gave Tiragolumab a safety rating of 1 out of 3 due to the fact that it is still in its preliminary testing phase, with limited data available to support both efficacy and security."

Answered by AI

What is the current capacity of this experimental endeavor?

"As of this moment, it does not seem that the trial is actively enrolling. The initial posting date was September 28th 2020 and data was last updated on November 22nd 2022. For those looking for other studies related to triple negative breast neoplasms or Tiragolumab, there are currently 2351 and 2324 respective clinical trials seeking out participants."

Answered by AI

Has a research effort of this kind ever been attempted before?

"Tiragolumab research has been ongoing since 1997, with Alfacell's Phase 3 study involving 300 participants kickstarting the process. Over the past two decades, 2324 trials have spanned 89 countries and 3970 cities - a total of 3167 studies in all."

Answered by AI

Is this study currently accepting participants?

"This study is no longer accepting applications; however, if you are seeking other medical trials there are presently 2351 active studies recruiting patients with triple negative breast neoplasms and an additional 2324 searching for those who can benefit from Tiragolumab."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer

2020. "A Study of the Safety, Efficacy, and Pharmacokinetics of Tiragolumab in Combination With Atezolizumab and Chemotherapy in Participants With Triple-Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04584112.