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Checkpoint Inhibitor

Pembrolizumab for 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

Has histological confirmation of HER2 normal breast carcinoma with a clinical diagnosis of IBC based on presence of inflammatory changes in the involved breast, including diffuse erythema and edema (peau d'orange), with or without an underlying palpable mass involving the majority of the skin of the breast; pathological evidence of dermal lymphatic invasion should be noted but is not required for diagnosis of inflammatory breast cancer regardless estrogen receptor (ER)/progesterone receptor (PR) status; OR has histological confirmation of triple negative breast carcinoma (HER2 normal, ER/PR < 10%) without clinical diagnosis of IBC

Is HER2 normal, defined as HER2 0 or 1+ by IHC and negative by FISH if performed; or HER2 is 2+ by IHC and negative by FISH; or HER2 negative by FISH if IHC is not performed

Must not have

Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy

Has a known malignancy (other than breast cancer) except basal cell carcinoma or squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 3 months post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how well pembrolizumab works in treating metastatic or recurrent inflammatory breast cancer or triple-negative breast cancer.

Who is the study for?

This trial is for patients with stage IV or recurrent inflammatory breast cancer or triple-negative breast cancer who have responded to or remained stable after prior chemotherapy. Participants must be able to consent, have good performance status (0-1 ECOG), use effective birth control, and have adequate organ function. Exclusions include HIV, severe psychiatric/substance abuse issues, recent live vaccines, ongoing anti-cancer treatments, certain autoimmune diseases, active infections requiring systemic therapy.

What is being tested?

The trial is testing pembrolizumab's effectiveness in treating advanced or returning inflammatory/triple-negative breast cancer that has responded to previous chemo. Pembrolizumab is an immunotherapy drug designed to boost the immune system's ability to fight cancer by blocking a specific pathway known as PD-1/PD-L1.

What are the potential side effects?

Pembrolizumab may cause side effects like fatigue, skin reactions at the injection site, diarrhea, liver inflammation (hepatitis), hormone gland problems (like thyroid disorders), and can sometimes trigger an immune response against normal organs which might require treatment with steroids.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is HER2 normal, and may or may not be inflammatory or triple negative.

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My cancer is HER2 negative based on specific tests.

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My cancer is stage IV or has come back and has been treated.

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My cancer did not worsen after 2 months of chemotherapy for advanced or recurrent disease.

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I am fully active or restricted in physically strenuous activity but can do light work.

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My blood and organ function tests are within the required ranges.

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I am using or willing to use effective birth control or abstain from sex during the study.

Exclusion Criteria

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

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I have an immune system disorder or am on medication that weakens my immune system.

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I have had skin cancer or cervical cancer but it was treated with the intent to cure.

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I have had pneumonitis treated with steroids or have it now.

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I am currently being treated for an infection.

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I have been treated with specific immune-targeting drugs before.

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I am currently receiving treatment for cancer that has spread.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 3 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 3 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 months post-treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Rate of disease control

Secondary study objectives

Biomarker analyses

Disease control survival

Overall survival time

Side effects data

From 2024 Phase 3 trial • 804 Patients • NCT03040999

64%

Radiation skin injury

63%

Stomatitis

58%

Anaemia

56%

Nausea

48%

Dry mouth

45%

Constipation

45%

Weight decreased

44%

Dysphagia

42%

Neutrophil count decreased

33%

Dysgeusia

33%

Vomiting

32%

Fatigue

31%

White blood cell count decreased

28%

Hypomagnesaemia

26%

Decreased appetite

25%

Hypothyroidism

25%

Hypokalaemia

24%

Lymphocyte count decreased

24%

Platelet count decreased

23%

Oropharyngeal pain

23%

Blood creatinine increased

22%

Diarrhoea

22%

Odynophagia

20%

Hypoacusis

20%

Alanine aminotransferase increased

20%

Hyponatraemia

19%

Tinnitus

19%

Oral candidiasis

19%

Asthenia

16%

Pyrexia

16%

Cough

15%

Aspartate aminotransferase increased

15%

Rash

14%

Insomnia

13%

Acute kidney injury

13%

Pharyngeal inflammation

13%

Pruritus

12%

Dysphonia

12%

Gamma-glutamyltransferase increased

11%

Pneumonia

11%

Dehydration

10%

Hyperthyroidism

10%

Hypoalbuminaemia

10%

Hypocalcaemia

10%

Headache

10%

Productive cough

Neck pain

Peripheral sensory neuropathy

Gastrooesophageal reflux disease

Hiccups

Hyperglycaemia

Hyperuricaemia

Dizziness

Hypophosphataemia

Urinary tract infection

Ear pain

Localised oedema

Hyperkalaemia

Erythema

Oral pain

Abdominal pain upper

Arthralgia

Anxiety

Febrile neutropenia

Dyspepsia

Saliva altered

Back pain

Oedema peripheral

Hypertension

Dyspnoea

Nasopharyngitis

Alopecia

Dry skin

Sepsis

Pneumonia aspiration

Trismus

Pneumonitis

Laryngeal oedema

Malnutrition

Pharyngeal haemorrhage

Cellulitis

Septic shock

Clostridium difficile colitis

Systemic infection

Cardiac arrest

Death

Bronchitis

Hepatitis

Immune-mediated hepatitis

Oesophagitis

General physical health deterioration

Hypophagia

Tumour haemorrhage

Cerebrovascular accident

Syncope

Acute respiratory failure

Aspiration

Colitis

Mouth haemorrhage

Hypersensitivity

Acute myocardial infarction

Abscess neck

Device related infection

Stoma site infection

Vascular device infection

Wound infection

Hypercalcaemia

Pulmonary embolism

Respiratory failure

100%

80%

60%

40%

20%

Study treatment Arm

Placebo + CRT Followed by Placebo

Pembrolizumab + CRT Followed by Pembrolizumab

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 (pembrolizumab)Experimental Treatment2 Interventions

Patients receive pembrolizumab 200mg IV over approximately 30 minutes on day 1. Cycles repeat every 21 days for 8 cycles and then pembrolizumab 400mg IV every 42 days for total up to 24 months in the absence of disease progression or unacceptable toxicity

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Pembrolizumab

2017

Completed Phase 3

~3150

0 / 13Eligibility criteria met