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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
Must not have
Previous history of contralateral invasive breast cancer
Uncontrolled hypertension
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

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 below
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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had breast cancer in the opposite breast before.
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My high blood pressure is not under control.
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My cancer has spread to other parts of my body.
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I have had breast cancer or DCIS on the same side before.
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I have not received any treatment for my current breast cancer diagnosis before joining this study.
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I have active tuberculosis.
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I have previously been treated with CD137 agonists or immune checkpoint inhibitors.
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I have a moderate to severe nervous system disorder.
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I have been treated with anthracyclines or taxanes for cancer.
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I have had a lump or part of my breast surgically removed.
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I have not had any cancer other than breast cancer in the last 5 years.
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I have an active hepatitis B infection.
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I have not had a severe infection in the last 28 days.
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I experience pain in my limbs due to poor blood flow.
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I have a history of specific lung conditions or currently active lung inflammation.
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I have had a surgery to check lymph nodes in my armpit before joining the study.
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I do not have heart conditions that would prevent me from taking certain cancer drugs.

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
This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of randomization through study follow-up, to the time the target number of events is obtained, up to 5 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
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 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%
Dyspnoea
19%
Cough
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%
Weight decreased
5%
Haemoptysis
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%
Lung infection
1%
Acute kidney injury
1%
Lower respiratory tract infection
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Depression
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
2,436 Previous Clinical Trials
1,090,085 Total Patients Enrolled
160 Trials studying Breast Cancer
90,892 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,542 Previous Clinical Trials
566,527 Total Patients Enrolled
97 Trials studying Breast Cancer
23,218 Patients Enrolled for Breast Cancer
NSABP Foundation IncLead Sponsor
88 Previous Clinical Trials
138,752 Total Patients Enrolled
46 Trials studying Breast Cancer
102,330 Patients Enrolled for Breast Cancer

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT03281954 — Phase 3
Breast Cancer Research Study Groups: Placebo, Atezolizumab
Breast Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03281954 — Phase 3
Atezolizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03281954 — Phase 3
~92 spots leftby Dec 2024
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