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Monoclonal Antibodies

Atezolizumab for Breast Cancer (IMpassion030 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 baseline to end of study (approximately 7 years)

Awards & highlights

IMpassion030 Trial Summary

This trial will compare two different treatments for triple negative breast cancer to see which is more effective.

Eligible Conditions

Breast Cancer

IMpassion030 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to end of study (approximately 7 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to end of study (approximately 7 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of study (approximately 7 years) for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Invasive Disease-Free Survival (iDFS)

Secondary outcome measures

Disease-Free Survival (DFS)

Distant RFI

Invasive Disease Free Survival (iDFS) including second primary non-breast invasive cancer

+9 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227

36%

Fatigue

35%

Alopecia

24%

Diarrhoea

23%

Nausea

23%

Decreased appetite

22%

Anaemia

20%

Asthenia

19%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Neuropathy peripheral

11%

Vomiting

11%

Stomatitis

10%

Arthralgia

Rash

Neutrophil count decreased

Dysgeusia

Paraesthesia

Headache

Pain in extremity

Peripheral sensory neuropathy

Insomnia

Mucosal inflammation

Back pain

Pneumonia

Febrile neutropenia

Abdominal pain

Dry skin

Lacrimation increased

Dizziness

Haemoptysis

Weight decreased

Malaise

Urinary tract infection

Nail disorder

Productive cough

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Pruritus

Upper respiratory tract infection

Alanine aminotransferase increased

Aspartate aminotransferase increased

Influenza like illness

Respiratory tract infection

Musculoskeletal chest pain

Lower respiratory tract infection

Acute kidney injury

Depression

Lung infection

Dehydration

Chronic obstructive pulmonary disease

Atrial fibrillation

Syncope

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

IMpassion030 Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Atezolizumab + ChemotherapyExperimental Treatment4 Interventions

Participants will receive atezolizumab (in combination with chemotherapy as described below) every 2 weeks for 10 doses, followed by atezolizumab maintenance therapy every 3 weeks to complete 1 year of treatment from the first dose Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)

Group II: ChemotherapyActive Control3 Interventions

Chemotherapy will consist of paclitaxel every week for 12 weeks, followed by dose-dense doxorubicin +cyclophosphamide or dose-dense epirubicin + cyclophosphamide every 2 weeks, for 4 doses supported with Granulocyte Colony-Stimulating Factor (G-CSF) or Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

2017

Completed Phase 3

~5860

Paclitaxel

2011

Completed Phase 4

~5380

Dose-dense Doxorubicin or dose-dense Epirubicin

2018

Completed Phase 3

~2210

Cyclophosphamide

1995

Completed Phase 3

~3780

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Institut Jules Bordet/Clinical Trials Support Unit (IJB/CTSU)UNKNOWN

Frontier Science & Technology Research Foundation, Inc.Industry Sponsor

7 Previous Clinical Trials

5,188 Total Patients Enrolled

1 Trials studying Breast Cancer

1,836 Patients Enrolled for Breast Cancer

Hoffmann-La RocheLead Sponsor

2,428 Previous Clinical Trials

1,086,851 Total Patients Enrolled

160 Trials studying Breast Cancer

91,467 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.

For what types of illnesses is Atezolizumab commonly prescribed?

"Atezolizumab, which is most often used to treat urothelial carcinoma that has metastasized to the ureter, can also be effective in treating corticotropin, kaposi's sarcoma aids related, and leukemia."

Answered by AI

Can you elaborate on other Atezolizumab trials that have been completed in the past?

"Atezolizumab is being trialled in 2096 separate studies, with 452 of those trials currently ongoing. The large number of trials for this medication are centred around Philadelphia, but there are 83495 locations worldwide running these tests."

Answered by AI

Have other research teams conducted similar studies before?

"Atezolizumab has a long history, with the first clinical trial beginning in 1997. Alfacell Corporation sponsored the original study which had 300 participants. After Phase 3 approval was given, 2096 trials popped up in 88 different countries and across 3694 cities."

Answered by AI

Are there any patients who can still join this clinical trial?

"The clinical trial is recruiting participants and the latest information available on clinicaltrials.gov was edited on 10/19/2022. This study was first posted on 8/2/2018 and they are looking for 2300 individuals total from 13 different sites."

Answered by AI

What are some of the potential risks associated with Atezolizumab?

"Atezolizumab has received a 3 from our analysts at Power. This is due to the fact that this medication is currently in Phase 3 clinical trials, meaning that there is some data supporting efficacy as well as multiple rounds of safety data."

Answered by AI

Where are the trial sites located?

"This study is being conducted at 13 different hospitals and cancer research centres, including Monter Cancer Center in Lake Success, New hampshire Hematology Oncology in Manchester, and Baptist - MD Anderson Cancer Center in Jacksonville."

Answered by AI

How many people are allowed to be a part of this experiment at one time?

"The sponsor, Hoffmann-La Roche, needs 2300 eligible patients in order to commence the clinical trial. The research will be conducted at various sites including Monter Cancer Center in Lake Success, New york and New hampshire Hematology Oncology in Manchester, New Hampshire."

Answered by AI

Recent research and studies

Expert Opinion on Biological TherapyJournal

Atezolizumab in the Treatment of Metastatic Triple-negative Breast Cancer

Pérez-García, José, Jesús Soberino, Fabricio Racca, María Gion, Agostina Stradella, and Javier Cortés. 2020. “Atezolizumab in the Treatment of Metastatic Triple-negative Breast Cancer”. Expert Opinion on Biological Therapy. Informa UK Limited. doi:10.1080/14712598.2020.1769063.

clinicaltrials.govStudy

A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer

2018. "A Study Comparing Atezolizumab (Anti PD-L1 Antibody) In Combination With Adjuvant Anthracycline/Taxane-Based Chemotherapy Versus Chemotherapy Alone In Patients With Operable Triple-Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03498716.