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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months post-treatment
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Rate of disease control
Secondary outcome measures
Biomarker analyses
Disease control survival
Overall survival time

Side effects data

From 2024 Phase 2 trial • 57 Patients • NCT03004183
21%
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%
Malnutrition, Hypercalcemia and Weakness
5%
Pneumothorax
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 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 2
~2010

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,710 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,082 Total Patients Enrolled
Clinton YamPrincipal InvestigatorM.D. Anderson Cancer Center
6 Previous Clinical Trials
1,159 Total Patients Enrolled

Media Library

Pembrolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT02411656 — Phase 2
Swelling Research Study Groups: Treatment (pembrolizumab)
Swelling Clinical Trial 2023: Pembrolizumab Highlights & Side Effects. Trial Name: NCT02411656 — Phase 2
Pembrolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02411656 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What therapeutic indications is Pembrolizumab normally utilized for?

"Pembrolizumab is a frequently utilized treatment method for malignant neoplasms, as well as unresectable melanoma, microsatellite instability high conditions and cancer progression after chemotherapy."

Answered by AI

What is the current sample size of this clinical trial?

"Affirmative. Information on clinicaltrials.gov attests to the fact that this medical trial, initially posted on June 11th 2015, is currently enrolling participants. A total of 35 individuals are required at a single location."

Answered by AI

Has the Federal Drug Administration given its approval to Pembrolizumab?

"Our team at Power gave Pembrolizumab a score of 2 on safety, since we only have preliminary information ensuring its security and not any data that can prove its efficacy."

Answered by AI

Are there any openings available to join this clinical investigation?

"According to clinicaltrials.gov, this medical experiment is in the process of recruiting members for participation. It was initially posted on June 11th 2015 and has been updated as recently as September 7th 2022."

Answered by AI

Has Pembrolizumab been tested in a research setting before?

"Currently, Pembrolizumab is the focus of 961 clinical trials worldwide. Of those studies, 122 are in their final phase and 35731 locations host these investigations. In particular, Houston Texas houses a significant portion of this research."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy
2015. "Pembrolizumab in Treating Patients With Stage IV Metastatic or Recurrent Inflammatory Breast Cancer or Triple-Negative Breast Cancer Who Have Achieved Clinical Response or Stable Disease to Prior Chemotherapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02411656.
All > Metastatic Triple Negative Breast Cancer > Triple Negative Breast Cancer
~25 spots leftby Dec 2028
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