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Pembrolizumab for Triple-Negative Breast Cancer
Phase 3
Waitlist Available
Led By Lajos Pusztai
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must not have metastatic disease (i.e., must be clinically M0 or Mx)
Patients must not be planning to receive concomitantly other biologic therapy, hormonal therapy, other chemotherapy, surgery or other anti-cancer therapy except radiation therapy while receiving treatment on this protocol
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years
Awards & highlights
Study Summary
This trial studies pembrolizumab to see how well it works in treating triple-negative breast cancer.
Who is the study for?
This trial is for adults with triple-negative breast cancer who've completed neoadjuvant chemotherapy and surgery, have no metastatic or recurrent disease, and no active hepatitis or infections. They must not be pregnant/nursing, have had certain prior treatments (like anti-HER2 therapies), live vaccines recently, or autoimmune diseases treated in the last 2 years.Check my eligibility
What is being tested?
The study tests Pembrolizumab as an additional treatment after standard therapy for triple-negative breast cancer. It's a phase III trial to see if this immunotherapy can prevent cancer from returning by helping the immune system attack remaining cancer cells.See study design
What are the potential side effects?
Pembrolizumab may cause side effects like fatigue, skin reactions, inflammation of organs such as lungs (pneumonitis), hormonal gland problems (thyroid issues), infusion-related reactions, and it could potentially worsen autoimmune conditions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has not spread to distant parts of my body.
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I am not planning to undergo any other cancer treatments except radiation while on this trial.
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I had a full medical check-up in the last 28 days.
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My kidney function is normal or near normal.
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I do not have an infection that needs treatment with medication.
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My cancer has not spread to distant parts of my body and has not come back in the same place.
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My breast cancer is triple-negative or has low hormone receptor levels.
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I haven't and won't receive HER2 or hormone therapy after initial chemo.
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I have at least 5 tissue slides from my cancer available for testing.
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I had chemotherapy before surgery to shrink my tumor.
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I can take care of myself but might not be able to do heavy physical work.
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I haven't needed steroids for lung inflammation in the last 2 years.
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I do not have an active hepatitis B or C infection.
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I am 18 years old or older.
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I had cancer cells in my underarm lymph nodes confirmed before treatment and only one sentinel lymph node removed after.
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I have never received immunotherapy treatments like anti-PD-L1.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Invasive disease-free survival (IDFS)
Physical function
Severity of fatigue
Secondary outcome measures
Distant recurrence-free survival (DRFS)
Emotional function and disease-related symptoms in patients receiving pembrolizumab
Impact of treatment and treatment-related symptoms on physical function in patients without therapy
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Arm II (pembrolizumab)Experimental Treatment6 Interventions
Patients receive pembrolizumab IV over 30 minutes on days 1 and 22. Cycles repeat every 42 days for 52 weeks in the absence of disease progression or unacceptable toxicity. Patients may undergo radiation therapy within 12 weeks of last breast cancer operation or after treatment. Patients may also undergo collection of blood samples throughout the trial.
Group II: Arm I (observation)Experimental Treatment6 Interventions
Patients receive no treatment but are monitored at standard clinical intervals during first year after randomization. Patients are examined every 12 weeks for 1 year, every 6 months for 4 years, and then annually for 5 years. Patients may undergo radiation therapy within 12 weeks of last breast cancer operation or after treatment. Patients may also undergo collection of blood samples throughout the trial.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Radiation Therapy
2017
Completed Phase 3
~7250
Pembrolizumab
2017
Completed Phase 2
~2010
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,687 Previous Clinical Trials
40,929,216 Total Patients Enrolled
941 Trials studying Breast Cancer
1,543,396 Patients Enrolled for Breast Cancer
Lajos PusztaiPrincipal InvestigatorSWOG Cancer Research Network
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has not spread to distant parts of my body.Your platelet count is at least 100,000 per microliter.You need to order specimen kits at least two weeks before registering the first patient at your site.I am not planning to undergo any other cancer treatments except radiation while on this trial.I had a full medical check-up in the last 28 days.Your ANC is at least 1,500 microliters.You need to have a blood test for thyroid hormones within 28 days before joining the study.Your total bilirubin level must be within a certain range, unless you have Gilbert's syndrome, in which case there is a different limit for your bilirubin level.Your liver enzyme levels are not more than 2.5 times the upper limit of normal.Your alkaline phosphatase level is not more than 2.5 times the upper limit of normal.My kidney function is normal or near normal.I have taken a pregnancy test in the last 28 days and it was negative.I do not have an infection that needs treatment with medication.I have not had cancer before, except for certain types that are exceptions.I am not HER2-positive according to specific cancer guidelines.My cancer has not spread to distant parts of my body and has not come back in the same place.I still have cancer in my breast larger than 1 cm after chemotherapy.My cancer is weakly ER/PR positive and I'm not eligible for hormone therapy.My cancer has not returned in the same place it was treated.I am not planning to take any treatments not allowed in the study.My breast cancer is triple-negative or has low hormone receptor levels.I haven't and won't receive HER2 or hormone therapy after initial chemo.I have at least 5 tissue slides from my cancer available for testing.I had chemotherapy before surgery to shrink my tumor.My last breast surgery for cancer removed all the cancer with clear margins.I can take care of myself but might not be able to do heavy physical work.I haven't needed steroids for lung inflammation in the last 2 years.I haven't needed treatment for an autoimmune disease in the last 2 years.I have not received any live vaccines in the last 30 days.I do not have an active hepatitis B or C infection.I am 18 years old or older.I had cancer cells in my underarm lymph nodes confirmed before treatment and only one sentinel lymph node removed after.You are not participating in another specific clinical trial or your surgeon has decided that a complete ALND is not the best option for you.I have never received immunotherapy treatments like anti-PD-L1.Your hemoglobin level is at least 9 grams per deciliter.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (pembrolizumab)
- Group 2: Arm I (observation)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Why is Patient Observation commonly used?
"Patient Observation can be used to treat malignant neoplasms, unresectable melanoma, and microsatellite instability high."
Answered by AI
Do you know of other research groups who have used Patient Observation in their work?
"City of Hope first began studying Patient Observation in 2010. To date, there have been 1050 completed trials. Currently, there are 1000 active trials, many of which are based in Lakewood, Colorado."
Answered by AI
Are people with the target condition still being sought for this treatment research?
"Unfortunately, this specific trial is no longer looking for patients. Although, as of October 18th, 2022, there are 5717 other trials that are actively recruiting."
Answered by AI
Is the Patient Observation method backed by the FDA?
"While Phase 3 trials don't have as much data supporting efficacy as later stages, there is still some data, as well as multiple rounds of data supporting safety. Therefore, our team at Power estimates the safety of Patient Observation to be a 3."
Answered by AI
Who else is applying?
What state do they live in?
California
How old are they?
18 - 65
What site did they apply to?
Atlantic Health Sciences Corporation-Saint John Regional Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
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