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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Disease free survival (DFS)
Secondary outcome measures
Incidence of adverse events
Overall survival (OS)
Side effects data
From 2024 Phase 2 trial • 57 Patients • NCT0300418321%
Fatigue
13%
Nausea
11%
Back pain
9%
Shortness of Breath
9%
Anemia
9%
Abdominal pain
9%
Diarrhea
7%
Pneumonia
7%
Kidney Injury and/or Infection
7%
Dyspnea
7%
Weight Loss
5%
Pneumothorax
5%
Malnutrition, Hypercalcemia and Weakness
5%
Intractable pain, back pain, hip pain
5%
Activated partial thromboplastin time prolonged
4%
Pleural effusion
4%
Atrial fibrillation with rapid ventricular response
2%
Thrombocytopenia
2%
Respiratory failure
2%
Skin rash
2%
colitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Single Arm
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 2
~2010
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,987 Previous Clinical Trials
1,798,198 Total Patients Enrolled
148 Trials studying Breast Cancer
63,277 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,277 Total Patients Enrolled
942 Trials studying Breast Cancer
1,543,966 Patients Enrolled for Breast Cancer
Clinton YamPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
1,193 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have an immune system disorder or am on drugs that weaken my immune system.I am 18 years old or older.I have an autoimmune disease that needed treatment in the last 3 months.I have had pneumonitis treated with steroids or have it now.I have been treated with specific antibodies before.I have been diagnosed with HIV.I have an active Hepatitis B or C infection.I have not received a live vaccine in the last 30 days.I have had issues with my digestive system or a history of colitis.I need daily corticosteroids through pills or infusion.My cancer did not fully respond to chemotherapy before surgery.My cancer is not HER2 positive.I am fully active or can carry out light work.I will start or have finished radiation and will begin hormone therapy within 4 weeks.I started hormone therapy within 6 months after radiation and can begin the study drug within 4 weeks after screening.I am currently being treated for an infection.My breast cancer has been confirmed through tissue examination.My breast cancer is confirmed as inflammatory by international standards.My organ functions are within normal ranges according to recent tests.My cancer is positive for estrogen or progesterone receptors.I have had cancer before, but it's one of the exceptions.I am still experiencing side effects from previous treatments.My breast cancer has spread beyond the breast and nearby lymph nodes.I haven't had a heart attack or severe heart issues in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (pembrolizumab)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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