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Monoclonal Antibodies

Atezolizumab for Breast Cancer (IMpassion050 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 randomization to date of death from any cause (up to approximately 54 months)
Awards & highlights

IMpassion050 Trial Summary

This trial will compare atezolizumab to placebo in neoadjuvant treatment for early HER2-positive breast cancer.

Eligible Conditions
  • Breast Cancer

IMpassion050 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to date of death from any cause (up to approximately 54 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to date of death from any cause (up to approximately 54 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
Percentage of Participants With Pathological Complete Response (pCR) in the PD-L1-Positive Population (IC 1/2/3)
pCR in the ITT Population
Secondary outcome measures
Cmax of Trastuzumab Emtansine in Serum
Cmin of Trastuzumab Emtansine in Serum
DFS Based on PIK3CA Mutation Status
+18 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
27%
Fatigue
25%
Decreased appetite
24%
Cough
19%
Dyspnoea
19%
Asthenia
18%
Constipation
18%
Pyrexia
18%
Nausea
16%
Diarrhoea
13%
Arthralgia
12%
Vomiting
12%
Anaemia
11%
Back pain
11%
Musculoskeletal pain
11%
Rash
10%
Headache
9%
Oedema peripheral
9%
Weight decreased
9%
Chest pain
9%
Insomnia
9%
Pruritus
9%
Pain in extremity
8%
Dizziness
7%
Upper respiratory tract infection
7%
Aspartate aminotransferase increased
7%
Myalgia
7%
Haemoptysis
6%
Influenza like illness
6%
Nasopharyngitis
6%
Alanine aminotransferase increased
6%
Bronchitis
6%
Productive cough
5%
Musculoskeletal chest pain
5%
Depression
5%
Dry skin
4%
Abdominal pain
4%
Urinary tract infection
4%
Neuropathy peripheral
4%
Paraesthesia
3%
Stomatitis
3%
Dysgeusia
3%
Pneumonia
2%
Malaise
2%
Pleural effusion
2%
Neutropenia
1%
Lacrimation increased
1%
Respiratory tract infection
1%
Sepsis
1%
Pneumonitis
1%
Mucosal inflammation
1%
Bone pain
1%
Pulmonary embolism
1%
Peripheral sensory neuropathy
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab
Docetaxel

IMpassion050 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Atezolizumab +ddAC-PacHPExperimental Treatment7 Interventions
Participants will receive atezolizumab (atezo) 840 mg IV Q2W for 4 cycles during neoadjuvant phase with ddAC (doxorubicin 60 mg/m2 & cyclophosphamide 600 mg/m2 IV), followed by atezo 1200 mg IV Q3W for 4 cycles with paclitaxel 80 mg/m2 IV weekly for 12 continuous weeks, trastuzumab 6 mg/kg IV (with initial 8mg/kg IV loading dose) Q3W for 4 cycles, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W for 4 cycles. During adjuvant phase, participants will continue to receive following study treatments Q3W to complete up to 1 year HER2-target therapy inclusive of therapy given both in neoadjuvant and adjuvant setting: atezo 1200 mg IV Q3W, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W. Participants who do not achieve pCR have option of receiving blinded atezo+trastuzumab emtansine post surgery for 14 cycles. In response to USM DIL dated 3 Feb 2021 treatment with atezo must be discontinued.
Group II: Placebo + ddAC-PacHPPlacebo Group7 Interventions
Participants will receive placebo 840 mg IV Q2W for 4 cycles during neoadjuvant phase with ddAC (doxorubicin 60 mg/m2 & cyclophosphamide 600 mg/m2 IV), followed by placebo 1200 mg IV Q3W for 4 cycles with paclitaxel 80 mg/m2 IV weekly for 12 continuous weeks, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W for 4 cycles & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W for 4 cycles. During adjuvant phase, participants will continue to receive following study treatments Q3W to complete up to 1 year HER2-target therapy inclusive of therapy given both in neoadjuvant & adjuvant setting: placebo 1200 mg IV Q3W, trastuzumab 6 mg/kg IV (with initial 8-mg/kg IV loading dose) Q3W, & pertuzumab 420 mg IV (with initial 840-mg IV loading dose) Q3W. Participants who do not achieve pCR have option of receiving blinded atezolizumab + trastuzumab emtansine post surgery for 14 cycles. In response to USM DIL, dated 3 Feb 2021 treatment with placebo must be discontinued.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~6040
Doxorubicin
2012
Completed Phase 3
~7940
Cyclophosphamide
1995
Completed Phase 3
~3780
Paclitaxel
2011
Completed Phase 4
~5380
Trastuzumab
2014
Completed Phase 4
~5190
Pertuzumab
2014
Completed Phase 3
~7500
Trastuzumab Emtansine
2016
Completed Phase 3
~5630

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,426 Previous Clinical Trials
1,088,715 Total Patients Enrolled
159 Trials studying Breast Cancer
91,013 Patients Enrolled for Breast Cancer
Chugai PharmaceuticalIndustry Sponsor
94 Previous Clinical Trials
21,065 Total Patients Enrolled
2 Trials studying Breast Cancer
280 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,197 Previous Clinical Trials
888,143 Total Patients Enrolled
137 Trials studying Breast Cancer
71,642 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 is the Atezolizumab FDA approval status?

"Power's team has given Atezolizumab a safety rating of 3. This is due to the fact that this drug has completed Phase 3 clinical trials, meaning that there is both efficacy and safety data available."

Answered by AI

Could you please share if there is any existing research on Atezolizumab?

"Atezolizumab was first studied in 1997 at Spectrum Health Hospital. As of now, there have been 20886 completed trials and 2228 live trials. The majority of these ongoing studies are based in New york City."

Answered by AI

For what purpose is Atezolizumab most often employed?

"Cyclophosphamide is typically treated with Atezolizumab, which can also help patients manage metastatic ureter urothelial carcinoma, kaposi's sarcoma aids related, and leukemia."

Answered by AI

How many subjects are trialing this medication?

"This clinical trial is not currently looking for new patients, as it has already reached its recruitment goals. The study was originally posted on 1/11/2019 and was last updated on 8/29/2022. However, there are 2677 other trials actively recruiting participants with breast cancer and 2228 trials for Atezolizumab actively admitting patients."

Answered by AI

In how many different healthcare facilities is this experiment being carried out presently?

"New york University Medical Center PRIME, NYU Langone Medical Center, Tennessee Oncology, Tom Baker Cancer Centre-Calgary, and 7 other locations are all participating in this study."

Answered by AI
~74 spots leftby Mar 2025