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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

Did not achieve pathological complete response (pCR) to any chemotherapy that was given with the intention to induce best response prior surgery

Is HER2 normal

Must not have

Has a diagnosis of immunodeficiency or any other form of immunosuppressive therapy

Has an active autoimmune disease requiring systemic treatment within the past 3 months or a documented history of clinically severe autoimmune disease, or immunosuppressive agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at how well pembrolizumab works for treating patients with hormone receptor positive inflammatory breast cancer who are receiving hormone therapy and didn't achieve a pathological complete response to chemotherapy.

Who is the study for?

This trial is for patients with hormone receptor positive inflammatory breast cancer that hasn't spread, who didn't fully respond to chemotherapy and are on hormone therapy. Eligible participants must have a certain level of neutrophils, not be pregnant or become pregnant, have started radiation or endocrine therapy recently if applicable, and meet specific health criteria like normal organ function tests.

What is being tested?

The trial is testing pembrolizumab's effectiveness in these patients. Pembrolizumab is an immunotherapy drug that may boost the immune system's ability to fight cancer by blocking tumor growth. This phase II study will assess how well it works when other treatments haven't led to complete cancer removal.

What are the potential side effects?

Pembrolizumab can cause side effects such as fatigue, skin reactions, diarrhea, hormonal gland problems (like thyroid dysfunction), liver inflammation, lung issues (pneumonitis), and could potentially worsen autoimmune diseases.

Eligibility Criteria

Inclusion Criteria

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

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My cancer did not fully respond to chemotherapy before surgery.

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My cancer is not HER2 positive.

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I am fully active or can carry out light work.

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My breast cancer has been confirmed through tissue examination.

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My breast cancer is confirmed as inflammatory by international standards.

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My organ functions are within normal ranges according to recent tests.

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My cancer is positive for estrogen or progesterone receptors.

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 drugs that weaken my immune system.

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I have an autoimmune disease that needed treatment in the last 3 months.

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

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I have been treated with specific antibodies before.

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I have been diagnosed with HIV.

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I have an active Hepatitis B or C infection.

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I have had issues with my digestive system or a history of colitis.

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I need daily corticosteroids through pills or infusion.

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I am currently being treated for an infection.

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My breast cancer has spread beyond the breast and nearby lymph nodes.

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I haven't had a heart attack or severe heart issues in the last 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 months for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Disease free survival (DFS)

Secondary study objectives

Incidence of adverse events

Overall survival (OS)

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

Systemic infection

Clostridium difficile colitis

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

Pembrolizumab + CRT Followed by Pembrolizumab

Placebo + CRT Followed by Placebo

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 Treatment1 Intervention

Patients receive pembrolizumab IV over 30 minutes on day 1. Cycles repeat every 21 days for 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

~3130

0 / 18Eligibility criteria met