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Checkpoint Inhibitor

Pembrolizumab for Breast Cancer

M D Anderson Cancer Center, Houston, TX
Targeting 9 different conditionsPembrolizumab +1 morePhase 2Waitlist AvailableLed by Clinton YamResearch Sponsored by M.D. Anderson Cancer Center

Study Summary

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

Eligible Conditions
  • Swelling
  • Breast Cancer
  • Erythema
  • Peau d'Orange

Eligibility Criteria

Inclusion Criteria

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

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 2021 Phase 3 trial • 453 Patients • NCT03066778
54%
Neutropenia
45%
Anaemia
38%
Nausea
34%
Alopecia
31%
Decreased appetite
29%
Constipation
27%
Fatigue
26%
Thrombocytopenia
22%
Leukopenia
21%
Diarrhoea
20%
Cough
17%
Asthenia
17%
Dyspnoea
16%
Vomiting
14%
Pyrexia
14%
Dizziness
13%
Headache
13%
Arthralgia
13%
Rash
12%
Hypothyroidism
11%
Pruritus
11%
Insomnia
11%
Back pain
10%
Weight decreased
9%
Hyponatraemia
9%
Aspartate aminotransferase increased
8%
Pneumonia
8%
Oedema peripheral
8%
Upper respiratory tract infection
8%
Alanine aminotransferase increased
7%
Febrile neutropenia
7%
Abdominal pain
7%
Blood creatinine increased
7%
Hypokalaemia
6%
Abdominal pain upper
6%
Stomatitis
6%
Dry skin
6%
Erythema
6%
Dysgeusia
5%
Hyperthyroidism
5%
Dyspepsia
5%
Dysphagia
5%
Nasopharyngitis
5%
Blood alkaline phosphatase increased
5%
Pain in extremity
5%
Musculoskeletal chest pain
5%
Musculoskeletal pain
5%
Chest pain
5%
Hypertension
4%
Hypotension
4%
Urinary tract infection
2%
Atrial fibrillation
2%
Death
2%
Acute kidney injury
2%
Pneumonitis
2%
Pulmonary embolism
1%
Hemiparesis
1%
Clostridium difficile colitis
1%
Neutropenic sepsis
1%
Pleural infection
1%
Sepsis
1%
Infusion related reaction
1%
Diabetes mellitus
1%
Aortic aneurysm
1%
Inappropriate antidiuretic hormone secretion
1%
Pneumothorax
1%
Transient ischaemic attack
1%
Gastritis
1%
Superior vena cava syndrome
100%
80%
60%
40%
20%
0%
Study treatment Arm
Pembrolizumab+EP
Placebo+EP
Pembrolizumab Second Course

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
~2030

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,914 Previous Clinical Trials
1,773,681 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,486 Previous Clinical Trials
41,265,866 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
~27 spots leftby Dec 2028