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Monoclonal Antibodies
Atezolizumab + Chemotherapy for Triple-Negative Breast Cancer (IMpassion132 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
Histologically confirmed triple negative breast cancer (TNBC) that is either locally recurrent, inoperable and cannot be treated with curative intent or is metastatic
Prior treatment (of early breast cancer) with an anthracycline and taxane
Must not have
Active tuberculosis
Major surgical procedure within 4 weeks prior to randomisation or anticipation of the need for a major surgical procedure during the course of the study other than for diagnosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline; every 8 weeks for the first 12 months after randomisation, and every 12 weeks thereafter until disease progression, withdrawal of consent, death, or study termination (approximately 58 months)
Awards & highlights
Pivotal Trial
Summary
This trial will test whether adding the immunotherapy drug atezolizumab to standard chemotherapy can help treat patients with inoperable, recurrent triple-negative breast cancer.
Who is the study for?
This trial is for patients with inoperable recurrent triple-negative breast cancer (TNBC) who haven't had chemotherapy or targeted therapy for their advanced disease. They must have a life expectancy of at least 12 weeks, be able to provide a tumor sample, and not have any severe infections or allergies related to the treatment. Women should agree to use effective contraception.
What is being tested?
The study tests the effectiveness and safety of combining Atezolizumab (an immunotherapy drug) with chemotherapy drugs like Capecitabine, Gemcitabine, and Carboplatin versus placebo plus chemotherapy in treating TNBC that has relapsed early after previous treatment.
What are the potential side effects?
Potential side effects include allergic reactions to ingredients, immune-related inflammation affecting various organs, fatigue, nausea, low blood cell counts increasing infection risk. Specific drugs may cause unique side effects such as hand-foot syndrome from Capecitabine.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is triple negative, cannot be surgically removed, and has spread.
Select...
I have been treated with anthracycline and taxane for early breast cancer.
Select...
I am fully active or can carry out light work.
Select...
I haven't had chemotherapy or targeted therapy for my advanced cancer, but may have had radiation.
Select...
I have tested negative for hepatitis B or have a negative HBV DNA test after a positive HBcAb test.
Select...
I agree to not have sex or use birth control and not donate sperm.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have active tuberculosis.
Select...
I haven't had major surgery in the last 4 weeks and don't expect any during the study.
Select...
I am allergic to some ingredients in atezolizumab or similar drugs.
Select...
I have brain metastases that are untreated or getting worse.
Select...
My cancer pain is not managed with current treatments.
Select...
I have had leptomeningeal disease.
Select...
I have previously been treated with specific immune therapy drugs.
Select...
I haven't taken steroids or immune-weakening drugs in the last 2 weeks.
Select...
I cannot swallow pills.
Select...
I have a condition that affects how my stomach or intestines absorb food.
Select...
I am allergic to platinum drugs or ingredients in carboplatin or gemcitabine.
Select...
I have not been treated with anthracycline or taxane.
Select...
I have high calcium levels in my blood that are causing symptoms.
Select...
I haven't had a severe infection needing antibiotics in the last 4 weeks.
Select...
I have had a previous transplant of stem cells or an organ.
Select...
I have a known DPD deficiency or had severe reactions to certain chemotherapy drugs.
Select...
I am currently on medication for hepatitis B.
Select...
My cancer is quickly worsening or causing symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline; every 8 weeks for the first 12 months after randomisation, and every 12 weeks thereafter until disease progression, withdrawal of consent, death, or study termination (approximately 58 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline; every 8 weeks for the first 12 months after randomisation, and every 12 weeks thereafter until disease progression, withdrawal of consent, death, or study termination (approximately 58 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Overall Survival (OS) in Modified Intent-To-Treat (mITT) Popluation
Overall Survival (OS) in Population With Programmed Death-Ligand 1 (PD-L1)-Positive Tumour Status
Secondary study objectives
Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR) in China Population
Duration of Objective Response (DoR)
+13 moreSide effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
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%
Stomatitis
11%
Vomiting
11%
Neuropathy peripheral
10%
Arthralgia
9%
Neutrophil count decreased
9%
Rash
8%
Dysgeusia
8%
Headache
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Febrile neutropenia
6%
Pneumonia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dry skin
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
Awards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AtezolizumabExperimental Treatment4 Interventions
Participants will receive Atezolizumab on day 1 of each 3-week treatment cycle
Group II: PlaceboPlacebo Group4 Interventions
Participants will receive Placebo on day 1 of each 3-week treatment cycle
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2016
Completed Phase 3
~5860
Gemcitabine
2017
Completed Phase 3
~1920
Capecitabine
2013
Completed Phase 3
~4280
Carboplatin
2014
Completed Phase 3
~6120
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,463 Previous Clinical Trials
1,102,532 Total Patients Enrolled
158 Trials studying Breast Cancer
90,262 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,233 Previous Clinical Trials
901,642 Total Patients Enrolled
137 Trials studying Breast Cancer
70,925 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have active tuberculosis.I haven't had major surgery in the last 4 weeks and don't expect any during the study.I am allergic to some ingredients in atezolizumab or similar drugs.My blood and organs are functioning well.My spinal cord compression hasn't been treated or wasn't stable for 2 weeks before joining.I have brain metastases that are untreated or getting worse.My cancer pain is not managed with current treatments.I have had leptomeningeal disease.You are expected to live for at least 12 weeks.You should have a negative hepatitis B surface antigen (HBsAg) test during the screening.I have previously been treated with specific immune therapy drugs.I haven't taken steroids or immune-weakening drugs in the last 2 weeks.I cannot swallow pills.I have a condition that affects how my stomach or intestines absorb food.I am allergic to platinum drugs or ingredients in carboplatin or gemcitabine.I have not been treated with anthracycline or taxane.I do not need frequent procedures to remove excess fluid from my body.I have high calcium levels in my blood that are causing symptoms.I have not had any cancer other than triple-negative breast cancer in the last 5 years.I have not had serious heart problems in the last 3 months.I have had a previous transplant of stem cells or an organ.I have a history of lung scarring or inflammation but not from radiation.I haven't taken any immune-boosting drugs in the last 4 weeks or longer.I have a known DPD deficiency or had severe reactions to certain chemotherapy drugs.I have been treated with anthracycline and taxane for early breast cancer.My cancer has worsened within a year after my last treatment aimed at curing it.I am fully active or can carry out light work.I haven't had chemotherapy or targeted therapy for my advanced cancer, but may have had radiation.I can provide a sample of my tumor for testing.I agree to use highly effective birth control or abstain from sex during and after treatment.My breast cancer is triple negative, cannot be surgically removed, and has spread.I haven't had a severe infection needing antibiotics in the last 4 weeks.I am currently on medication for hepatitis B.You have a disease that can be measured or not measured according to specific guidelines.You do not have HIV.I have tested negative for hepatitis B or have a negative HBV DNA test after a positive HBcAb test.My tumor is PD-L1 positive with more than 1% expression on immune cells.Your ECG shows an abnormal heart rhythm.I have not received a live vaccine in the last 4 weeks and do not plan to during or within 5 months after treatment.You have had an autoimmune disease in the past.You have had a serious allergic reaction to certain types of medications in the past.I agree to not have sex or use birth control and not donate sperm.You tested negative for hepatitis C virus (HCV) or tested positive for HCV but then tested negative for HCV RNA.My cancer is quickly worsening or causing symptoms.
Research Study Groups:
This trial has the following groups:- Group 1: Atezolizumab
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.