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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

All Individual Drugs Already Approved

Pivotal Trial

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.

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.

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 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

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Event-free survival (EFS)

Secondary study objectives

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%

Cough

19%

Dyspnoea

16%

Myalgia

15%

Neutropenia

14%

Constipation

14%

Oedema peripheral

12%

Pyrexia

11%

Stomatitis

11%

Vomiting

11%

Neuropathy peripheral

10%

Arthralgia

Neutrophil count decreased

Rash

Headache

Dysgeusia

Paraesthesia

Pain in extremity

Mucosal inflammation

Back pain

Peripheral sensory neuropathy

Insomnia

Febrile neutropenia

Pneumonia

Lacrimation increased

Abdominal pain

Dry skin

Dizziness

Malaise

Urinary tract infection

Weight decreased

Haemoptysis

Nail disorder

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Productive cough

Upper respiratory tract infection

Pruritus

Influenza like illness

Alanine aminotransferase increased

Aspartate aminotransferase increased

Syncope

Dehydration

Atrial fibrillation

Lower respiratory tract infection

Lung infection

Respiratory tract infection

Acute kidney injury

Chronic obstructive pulmonary disease

Pleural effusion

Depression

Musculoskeletal chest pain

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Awards & Highlights

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.

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

0 / 26Eligibility criteria met