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Monoclonal Antibodies
Chemotherapy + Atezolizumab for Breast Cancer
Phase 3
Waitlist Available
Led By Norman Wolmark, MD
Research Sponsored by NSABP Foundation Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
The ECOG performance status must be 0-1.
The diagnosis of invasive adenocarcinoma of the breast must have been made by core needle biopsy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 years
Awards & highlights
Study Summary
This trial is studying whether a combination of the standard chemotherapy regimen for breast cancer plus the experimental drug atezolizumab is more effective than the standard chemotherapy regimen plus a placebo.
Who is the study for?
This trial is for adults with triple-negative breast cancer who haven't had certain treatments yet. They should be relatively healthy, able to perform daily activities (ECOG 0-1), and have normal organ function. Women must not be pregnant or breastfeeding and agree to contraception if of childbearing potential.Check my eligibility
What is being tested?
The study tests whether adding Atezolizumab to standard pre-surgery chemotherapy is more effective than chemo with a placebo in shrinking tumors and preventing cancer return post-surgery. After surgery, patients may continue receiving Atezolizumab or placebo to further assess benefits.See study design
What are the potential side effects?
Atezolizumab can cause side effects like immune-related inflammation in various organs, infusion reactions that may feel like an allergic response, fatigue, digestive issues such as nausea or diarrhea, blood disorders including low counts of different cell types, and increased risk of infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or can carry out light work.
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My breast cancer was diagnosed with a needle biopsy.
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I am fully active or can carry out light work.
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I have HER2-negative breast cancer in both breasts or in multiple areas of one breast.
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My kidney function, measured by creatinine clearance, is good.
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I am 18 years old or older.
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My breast cancer is at stage T2 or T3 and has not spread to my lymph nodes.
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My cancer is triple-negative.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Event-free survival (EFS)
Secondary outcome measures
Cardiac safety lead-in (Left ventricular ejection fraction; LVEF)
Cardiac safety lead-in (Troponin-T)
Disease-free survival (DFS)
+5 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%
Respiratory tract infection
1%
Musculoskeletal chest pain
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
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: AtezolizumabExperimental Treatment1 Intervention
IV infusion, 1200mg, once every 3 weeks for 4 doses (Cycle 1), once every 3 weeks for 4 doses (Cycle 2) and once every 3 weeks after surgery for 1 year after first dose
Group II: PlaceboPlacebo Group1 Intervention
IV infusion once every 3 weeks for 4 doses (Cycle 1), once every 3 weeks for 4 doses (Cycle 2) and once every 3 weeks after surgery for 1 year after first dose
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
FDA approved
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheIndustry Sponsor
2,428 Previous Clinical Trials
1,087,504 Total Patients Enrolled
160 Trials studying Breast Cancer
91,467 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,539 Previous Clinical Trials
566,139 Total Patients Enrolled
97 Trials studying Breast Cancer
23,218 Patients Enrolled for Breast Cancer
NSABP Foundation IncLead Sponsor
86 Previous Clinical Trials
135,438 Total Patients Enrolled
45 Trials studying Breast Cancer
100,530 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had breast cancer in the opposite breast before.You have had a transplant using cells or organs from another person.My high blood pressure is not under control.You have been diagnosed with HIV.Using fine needle aspiration alone for diagnosing breast cancer.You have agreed to take part in the study and have signed a form that explains the study and how your information will be used. This includes giving a sample of your tumor for research purposes.I am fully active or can carry out light work.My breast cancer was diagnosed with a needle biopsy.My cancer has spread to other parts of my body.I have had breast cancer or DCIS on the same side before.I have not received any treatment for my current breast cancer diagnosis before joining this study.I have active tuberculosis.I have not received a live vaccine in the last 28 days.You have or had a disease that affects your immune system.You have an active hepatitis C virus (HCV) infection.I have been treated with anthracyclines or taxanes for cancer.You have a history of severe allergic reactions.I have HER2-negative breast cancer in both breasts or in multiple areas of one breast.Your recent blood tests must show specific levels to qualify for the study.My kidney function, measured by creatinine clearance, is good.Your blood clotting test results must be within the normal range within 28 days before joining the study.I have had a lump or part of my breast surgically removed.I have not had any cancer other than breast cancer in the last 5 years.I have an active hepatitis B infection.I have not had a severe infection in the last 28 days.I do not have any health conditions that prevent me from taking experimental drugs.I experience pain in my limbs due to poor blood flow.I am 18 years old or older.My breast cancer is at stage T2 or T3 and has not spread to my lymph nodes.I have previously been treated with CD137 agonists or immune checkpoint inhibitors.I have a moderate to severe nervous system disorder.I am either female or male.I am fully active or can carry out light work.Your heart function must be checked within 42 days before you can join the study.I have a history of specific lung conditions or currently active lung inflammation.My cancer is triple-negative.I have had a surgery to check lymph nodes in my armpit before joining the study.My underarm lymph nodes on the same side as my tumor were checked by a scan within the last 84 days.I am 18 years old or older.I do not have heart conditions that would prevent me from taking certain cancer drugs.My liver is functioning well, as confirmed by tests within the last 28 days.I am either female or male.I haven't taken any immune-weakening drugs recently.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo
- Group 2: Atezolizumab
Awards:
This trial has 2 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- 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.
Could you explain the main reasons why Atezolizumab is used?
"Atezolizumab is an effective treatment for small cell lung cancer (sclc), malignant neoplasms, and non-small cell lung carcinoma."
Answered by AI
What is the scientific basis for Atezolizumab's effectiveness?
"Atezolizumab was first studied in 2008 and, to date, 18363 have completed the necessary research. There are currently 357 live studies being conducted with a large number of them based out of Bristol, Virginia."
Answered by AI
How many different medical clinics are conducting this study?
"Presently, this trial is running at 100 sites. The locations are located in Bristol, Columbus and Erie along with other locations 100 other locations. If you enroll, it would be helpful to choose the site closest to your location so that you don't have to travel as much."
Answered by AI
Are there any patients who can still join this clinical trial?
"Unfortunately, this particular clinical trial is not currently looking for patients. Although the last edit was made on 7/27/2022, the study originally posted over 4 years ago on 12/19/2017. Having said that, there are 2793 other active studies which are recruiting right now."
Answered by AI
To the best of your knowledge, does a similar study exist?
"Atezolizumab was first studied in 2008 by Hoffmann-La Roche. After the initial Phase 1 clinical trial with 720 patients, Atezolizumab received drug approval and moved on to Phase 2 trials. There are currently 357 active studies taking place in 1665 cities and 74 countries."
Answered by AI
How many people are currently allowed to participate in this research project?
"This particular clinical trial is no longer looking for patients. The study was first posted on December 19th, 2017 and had its last update on July 27th, 2022. However, there are 2436 other trials actively searching for patients with triple negative breast neoplasms and 357 studies involving Atezolizumab that need participants."
Answered by AI
What is the Atezolizumab FDA status?
"Atezolizumab has received a score of 3 for safety. This is because it is in Phase 3 clinical trials, which suggests that not only is the medication effective, but that there is also data supporting its safety from multiple rounds of testing."
Answered by AI
Who else is applying?
What state do they live in?
California
Pennsylvania
How old are they?
< 18
65+
What site did they apply to?
Kaiser Permanente-Anaheim
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
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