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Monoclonal Antibodies

Nab-Paclitaxel + Atezolizumab for Triple Negative Breast Cancer

Phase 2

Waitlist Available

Led By Clinton Yam

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Estrogen receptor (ER) and progesterone receptor (PR) expression both < 10% by immunohistochemistry (IHC) and human epidermal growth factor receptor 2 (HER2) negative or non-amplified as determined by the current American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) criteria

Histologically confirmed primary invasive adenocarcinoma of the breast with the size of the primary tumor being at least 1.5 cm, or at least 1 biopsy confirmed involved lymph node > 1.5 cm, on imaging by either mammography, ultrasound or breast magnetic resonance imaging (MRI)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 years

Awards & highlights

Study Summary

This trial is studying how well nab-paclitaxel and atezolizumab work in treating patients with triple negative breast cancer.

Who is the study for?

This trial is for women with triple negative breast cancer who haven't had certain treatments. They must have a tumor of at least 1.5 cm or a lymph node over this size, be able to get pregnant and agree to use contraception, and have no prior malignancies within the last 5 years except some skin cancers or cervical carcinoma in situ.Check my eligibility

What is being tested?

The study tests nab-paclitaxel combined with atezolizumab before surgery in patients with triple negative breast cancer. It aims to see if this drug combo can shrink tumors effectively enough to reduce the amount of tissue removed during surgery.See study design

What are the potential side effects?

Possible side effects include reactions related to immune system activation such as inflammation, fatigue, allergic responses from infusion, potential harm to organs like liver or lungs, and increased risk of infections due to weakened immunity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is mostly not driven by estrogen, progesterone, or HER2.

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My breast cancer is confirmed and the tumor is at least 1.5 cm or I have a lymph node larger than 1.5 cm.

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I am fully active or can carry out light work.

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My tumor did not shrink enough after chemotherapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 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

Breast

Secondary outcome measures

Overall survival (OS)

Progression free survival (PFS)

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%

Neuropathy peripheral

11%

Vomiting

11%

Stomatitis

10%

Arthralgia

Rash

Neutrophil count decreased

Dysgeusia

Paraesthesia

Headache

Pain in extremity

Peripheral sensory neuropathy

Insomnia

Mucosal inflammation

Back pain

Pneumonia

Febrile neutropenia

Abdominal pain

Dry skin

Lacrimation increased

Dizziness

Haemoptysis

Weight decreased

Malaise

Urinary tract infection

Nail disorder

Productive cough

Chest pain

Nasopharyngitis

Musculoskeletal pain

Bronchitis

Pruritus

Upper respiratory tract infection

Alanine aminotransferase increased

Aspartate aminotransferase increased

Influenza like illness

Respiratory tract infection

Musculoskeletal chest pain

Lower respiratory tract infection

Acute kidney injury

Depression

Lung infection

Dehydration

Chronic obstructive pulmonary disease

Atrial fibrillation

Syncope

Pleural effusion

100%

80%

60%

40%

20%

Study treatment Arm

Docetaxel

Atezolizumab

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (atezolizumab, nab-paclitaxel)Experimental Treatment2 Interventions

NEOADJUVANT: Patients receive atezolizumab IV over 60 minutes on day 1 and nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. SURGERY: Patients undergo definitive breast surgery within 6 weeks of the completion of treatment. ADJUVANT: Within 4 weeks after surgery, patients receive atezolizumab IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Atezolizumab

FDA approved

Paclitaxel

FDA approved

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,967 Previous Clinical Trials

1,804,765 Total Patients Enrolled

148 Trials studying Breast Cancer

63,286 Patients Enrolled for Breast Cancer

Clinton YamPrincipal InvestigatorM.D. Anderson Cancer Center

6 Previous Clinical Trials

1,193 Total Patients Enrolled

Media Library

Atezolizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT02530489 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are enrollment opportunities currently available for this experiment?

"This research has reached its recruitment target, as indicated by the last update on April 6th 2021. If you are looking for other trials related to triple negative breast neoplasms and Atezolizumab, there is a combined total of 5766 clinical studies currently enrolling participants."

Answered by AI

What other research efforts have focused on Atezolizumab?

"Presently, there are 1166 studies being conducted on Atezolizumab, with 284 of those in Phase 3. Predominately situated in Woolloongabba, Queensland, these trials span across 60778 sites globally."

Answered by AI

Has the United States Food and Drug Administration given their blessing to Atezolizumab?

"With the available evidence, Atezolizumab is estimated to be a 2 on our 1-3 safety scale. This rating indicates that there are clinical data points affirming its protection but none supporting efficacy yet."

Answered by AI

What is the total number of participants in this research endeavor?

"At the moment, no new participants are being accepted for this trial. It was initially opened on February 4th 2016 and last updated April 6th 2021. If you search through other studies, there are currently 4600 trials open to those with triple negative breast neoplasms and 1166 seeking volunteers that can take part in Atezolizumab research."

Answered by AI

What conditions is Atezolizumab commonly utilized to treat?

"Atezolizumab is the conventional medication used to prevent central volume depletion. Additionally, it can be employed for treating neoplasm metastasis, hypoalbuminemia, and acute pyelonephritis (APN)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Nab-Paclitaxel and Atezolizumab Before Surgery in Treating Patients With Triple Negative Breast Cancer

2016. "Nab-Paclitaxel and Atezolizumab Before Surgery in Treating Patients With Triple Negative Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02530489.

All > Metastatic Triple Negative Breast Cancer > Triple Negative Breast Cancer