What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving immunotherapies like pembrolizumab and targeted therapies like trastuzumab, can have a range of side effects. Pembrolizumab may cause fatigue, rash, diarrhea, and immune-related adverse events such as pneumonitis, colitis, and hepatitis. Trastuzumab can lead to cardiotoxicity, infusion reactions, and gastrointestinal symptoms. Chemotherapy, often used in combination, typically results in nausea, hair loss, neutropenia, and fatigue. These side effects vary in severity and frequency among patients.

What prior FDA approvals exist?

The FDA has approved several immune checkpoint inhibitors for the treatment of breast cancer, particularly those targeting the PD-1/PD-L1 pathway. A notable example is atezolizumab, an anti-PD-L1 antibody, which has been approved in combination with nab-paclitaxel for the treatment of PD-L1-positive, metastatic triple-negative breast cancer. Pembrolizumab, an anti-PD-1 antibody, has also been approved for high-risk, early-stage triple-negative breast cancer in combination with chemotherapy. These treatments, like the investigational M7824, aim to enhance the immune system's ability to attack cancer cells by inhibiting pathways that tumors use to evade immune detection.

What other types of research exist?

Promising novel alternatives to M7824 for breast cancer patients include BR102, a bifunctional fusion protein targeting PD-L1 and TGF-β, which has shown efficacy and safety in preclinical studies. Additionally, other emerging therapies such as personalized, genotype-directed treatments and novel immunotoxins targeting specific cancer epitopes (e.g., 806-PE38 for EGFR-positive triple-negative breast cancer) are also being developed and may offer new options for patients in 2024.

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PD-L1/TGFbetaRII Inhibitor

Immunotherapy with Bintrafusp Alfa for Breast Cancer

Phase 1

Waitlist Available

Led By Rashmi K Murthy

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

Female subjects must either be of non-reproductive potential or must have a negative serum pregnancy test upon study entry and be using highly effective contraception

Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year

Awards & highlights

Study Summary

This trial studies how well M7824 works in treating patients with stage II-III HER2 positive breast cancer. M7824 is an immunotherapy that may help the body's immune system attack the cancer.

Who is the study for?

This trial is for women and men with stage II-III HER2 positive breast cancer, who have not been treated with PD-1/PD-L1 or CTLA-4 inhibitors. Participants must have a tumor size of at least 2 cm, no distant metastasis, proper liver and kidney function, an acceptable blood count, and use effective contraception. They should be able to follow the study protocol.Check my eligibility

What is being tested?

The trial is testing M7824 (Bintrafusp Alfa), which may boost the immune system's ability to fight cancer and prevent tumor growth in patients with specific breast cancer. It's an early-phase study to see how well this immunotherapy works.See study design

What are the potential side effects?

Potential side effects of M7824 could include typical reactions related to immunotherapies such as fatigue, skin reactions, inflammation in various organs like lungs or intestines (colitis), hormonal gland problems (like thyroid issues), or infusion-related reactions.

Eligibility Criteria

Inclusion Criteria

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

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I am not pregnant and use effective birth control or cannot become pregnant.

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I am fully active or can carry out light work.

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My tumor is at least 2 cm big and has not spread to distant parts of my body.

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My breast cancer is HER2 positive according to ASCO-CAP guidelines.

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My kidneys are functioning well, with a creatinine clearance rate of at least 60 mL/min.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in tumor-infiltrating lymphocytes (TIL) percentage

Electrocardiogram parameters

Eye symptoms (and signs if symptoms warranted additional evaluation)

+2 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%

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

Musculoskeletal chest pain

Respiratory tract infection

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 (M7824)Experimental Treatment1 Intervention

Participants receive anti-PD-L1/TGFbetaRII fusion protein M7824 IV over 1 hour on days 1 and 15. During days 28-56 participants receive planned neoadjuvant chemotherapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bintrafusp alfa

Not yet FDA approved

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include immunotherapy, chemotherapy, hormone therapy, and targeted therapy. Immunotherapy, such as the anti-PD-L1/TGFbetaRII fusion protein M7824, works by enhancing the body's immune response to attack cancer cells and inhibiting tumor growth. This is particularly important for breast cancer patients as it offers a novel approach to treatment, potentially improving outcomes for those who may not respond well to traditional therapies. Chemotherapy targets rapidly dividing cells, hormone therapy blocks hormones that fuel certain cancers, and targeted therapy focuses on specific molecular targets associated with cancer growth. Understanding these mechanisms helps patients and doctors make informed decisions about the most appropriate treatment options.