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

Must not have

Active tuberculosis

History of organ transplants that require immunosuppression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial studies how well M7824 works in treating patients with stage II-III HER2 positive breast cancer. M7824 is a medicine that helps the immune system fight cancer and stops cancer cells from growing. The trial aims to see if this treatment can improve immune response and reduce tumor size.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active tuberculosis.

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I have had an organ transplant and take medicine to prevent rejection.

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I have or had inflammatory bowel disease.

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I have inflammatory breast cancer.

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I have been treated with a PD-1, PD-L1, or CTLA-4 inhibitor before.

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I have had an autoimmune disease in the last 2 years.

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I have not received a live vaccine within 30 days before joining the study or before getting M7824.

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I have seizures that are not controlled by medication.

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I haven't had major surgery, except for a biopsy, in the last 4 weeks.

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I have a history of bleeding disorders.

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I do not have any uncontrolled illnesses.

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I have had cancer before, but it fits the exceptions.

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I am not pregnant, breastfeeding, or if capable of having children, I am using effective birth control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

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

Dysgeusia

Headache

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 18Eligibility 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.