Your session is about to expire
← Back to Search
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
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
IMpassion132 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.Check my eligibility
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.See study design
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.
IMpassion132 Trial 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.
IMpassion132 Trial 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
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
Clinical Benefit Rate (CBR)
Clinical Benefit Rate (CBR) in China Population
Confirmed Objective Response Rate (C-ORR)
+26 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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Pain in extremity
7%
Peripheral sensory neuropathy
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Musculoskeletal chest pain
1%
Respiratory tract infection
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
IMpassion132 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
Gemcitabine
2017
Completed Phase 3
~2070
Atezolizumab
2017
Completed Phase 3
~5860
Capecitabine
2013
Completed Phase 3
~3420
Carboplatin
2014
Completed Phase 3
~6670
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,496 Total Patients Enrolled
160 Trials studying Breast Cancer
91,467 Patients Enrolled for Breast Cancer
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
887,876 Total Patients Enrolled
138 Trials studying Breast Cancer
72,096 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are new patients being signed up for this clinical trial at the current time?
"This clinical trial, which was first posted on January 11th 2018, is looking for patients and has been updated as recently as November 14th 2022 according to the website clinicaltrials.gov"
Answered by AI
Has Atezolizumab undergone the FDA's approval process?
"Atezolizumab has received a score of 3 for safety. This is because it is in Phase 3 clinical trials, meaning that efficacy has been supported by some data and multiple rounds support its safety."
Answered by AI
If so, could you please share the details of other Atezolizumab clinical trials?
"As of now, there are 1687 ongoing clinical trials testing Atezolizumab. Of these, 490 have reached Phase 3. Though most of the research is located in Guangzhou, Guangdong, 84501 different locations are running studies on Atezolizumab."
Answered by AI
What are Atezolizumab's primary therapeutic benefits?
"Atezolizumab is most commonly used to treat urinary bladder issues. Additionally, it has shown efficacy in treating refractory fallopian tube carcinoma, small cell lung cancer (sclc), and advanced testicular cancer."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger