Monoclonal Antibodies
Pembrolizumab for Breast Cancer
Seattle Cancer Care Alliance / University of Washington, Seattle, WA
Pembrolizumab +1 morePhase 1 & 2Waitlist AvailableResearch Sponsored by Seagen Inc.Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At least 6 months since prior treatment with curative intent and recurrence
Be older than 18 years old
Must not have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Upup to 18 weeks following last dose; approximately 1 year
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is testing a new cancer treatment involving two drugs. It will study the side effects and if the drugs are effective in treating triple-negative breast cancer.
Eligible Conditions
- Triple Negative Breast Cancer
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have not received treatment intended to cure the disease for at least 6 months and the disease has come back.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 weeks following last dose; approximately 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 weeks following last dose; approximately 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Confirmed objective response rate
Incidence of adverse events
Incidence of dose-limiting toxicities
+1 moreSecondary outcome measures
Disease control rate
Duration of response
Overall survival
+1 moreSide effects data
From 2021 Phase 3 trial • 453 Patients • NCT0306677854%
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%
Aspartate aminotransferase increased
9%
Hyponatraemia
8%
Pneumonia
8%
Oedema peripheral
8%
Upper respiratory tract infection
8%
Alanine aminotransferase increased
7%
Abdominal pain
7%
Blood creatinine increased
7%
Hypokalaemia
7%
Febrile neutropenia
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%
Musculoskeletal chest pain
5%
Pain in extremity
5%
Musculoskeletal pain
5%
Chest pain
5%
Hypertension
4%
Hypotension
4%
Urinary tract infection
2%
Death
2%
Acute kidney injury
2%
Pneumonitis
2%
Pulmonary embolism
2%
Atrial fibrillation
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%
Hemiparesis
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: LV + pembrolizumabExperimental Treatment2 Interventions
LV + pembrolizumab
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
FDA approved
Ladiratuzumab vedotin
Not yet FDA approved
Find a site
Who is running the clinical trial?
Seagen Inc.Lead Sponsor
200 Previous Clinical Trials
67,875 Total Patients Enrolled
5 Trials studying Breast Cancer
3,278 Patients Enrolled for Breast Cancer
Merck Sharp & Dohme LLCIndustry Sponsor
3,793 Previous Clinical Trials
5,001,770 Total Patients Enrolled
58 Trials studying Breast Cancer
7,715 Patients Enrolled for Breast Cancer
Zejing Wang, MD, PhDStudy Director
Seagen Inc.2 Previous Clinical Trials
495 Total Patients Enrolled
Sinhan Tran, PharmD, MBAStudy Director
Seagen Inc.2 Previous Clinical Trials
495 Total Patients Enrolled
Kristel Apolinario, PharmDStudy Director
Seagen Inc.1 Previous Clinical Trials
290 Total Patients Enrolled
Brandon Croft, PharmDStudy Director
Seagen Inc.3 Previous Clinical Trials
720 Total Patients Enrolled
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What are some of the conditions that Pembrolizumab has been proven to be an effective treatment for?
"Pembrolizumab, while most effective for malignant neoplasms, can also serve as treatment for unresectable melanoma, microsatellite instability high, and disease progression after chemotherapy."
Answered by AI
What are we hoping to learn or achieve from this research?
"The purpose of this study, as it will be evaluated over a 10 month period, is to establish the adverse event rate. Additionally, the trial will secondary measure progress-free survival (PFS), overall survival (OS), and disease control rate (DCR)."
Answered by AI
Are there any open spots left in this trial for new patients?
"Yes, the latest information available on clinicaltrials.gov indicates that this study is still recruiting patients. The study was first posted on February 27th, 2018 and was last updated on October 28th, 2020. A total of 211 participants are needed, and so far 24 sites have agreed to take part."
Answered by AI
Are there similar ongoing Pembrolizumab trials elsewhere?
"City of Hope first researched pembrolizumab in 2010 and there have been 248 trials completed as of now. 1003 additional studies are still active, with a significant portion being conducted in Minneapolis, Minnesota."
Answered by AI