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Checkpoint Inhibitor
Pembrolizumab for Triple-Negative Breast Cancer
Phase 3
Recruiting
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Estrogen (ER) and progesterone (PR) =< 10%; HER2-negative by American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines (immunohistochemistry [IHC] and fluorescence in situ hybridization [FISH])
Patients must have received neoadjuvant chemotherapy in combination with pembrolizumab for a minimum of 6 cycles. All systemic chemotherapy and ICI therapy should have been completed preoperatively
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 10 years.
Awards & highlights
Study Summary
This trial will study if immunotherapy with pembrolizumab can help prevent the return of triple-negative breast cancer after preoperative chemotherapy.
Who is the study for?
This trial is for adults over 18 with early-stage triple-negative breast cancer who had no invasive disease after preoperative chemo and pembrolizumab. They must have completed at least 6 cycles of this treatment, be HIV-positive on effective therapy if applicable, not pregnant or nursing, and without severe active liver disease or a history of certain heart conditions.Check my eligibility
What is being tested?
The study compares the effects of continuing pembrolizumab to just observation in patients who've had a complete response to initial treatment. It aims to see if further immunotherapy reduces the risk of cancer returning compared to monitoring without additional drug intervention.See study design
What are the potential side effects?
Pembrolizumab may cause immune-related side effects such as inflammation in various organs, potential infusion reactions (like allergic responses during administration), fatigue, skin issues, hormonal gland problems like thyroid dysfunction, and could possibly worsen existing infections.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is mostly not driven by estrogen or progesterone and is not HER2 positive.
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I completed at least 6 cycles of chemotherapy with pembrolizumab before surgery.
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I am 18 years old or older.
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I can take care of myself and am up and about more than 50% of my waking hours.
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My breast cancer was stage T1cN1-2 or T2-4N0-2 according to AJCC 8th edition.
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My last surgery was no more than 12 weeks ago.
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All visible cancer was removed from my breast and lymph nodes through surgery.
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I am not currently using any experimental cancer treatments.
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
Recurrence-free survival (RFS)
Secondary outcome measures
Incidence of adverse events (AEs)
Locoregional recurrence incidence
Overall survival
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm II (observation)Experimental Treatment5 Interventions
Patients undergo observation on study. Patients also undergo tumor biopsy on study, and collection of blood on study and during follow-up.
Group II: Arm I (pembrolizumab)Active Control5 Interventions
Patients receive pembrolizumab IV on study. Patients also undergo tumor biopsy on study, and collection of blood on study and during follow-up.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1700
Biopsy
2014
Completed Phase 4
~1090
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,670 Previous Clinical Trials
40,925,441 Total Patients Enrolled
940 Trials studying Breast Cancer
1,543,360 Patients Enrolled for Breast Cancer
Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
216,343 Total Patients Enrolled
75 Trials studying Breast Cancer
40,143 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have never had a severe allergic reaction to pembrolizumab or similar medications.Your total bilirubin level is not more than 1.5 times the upper limit of normal.Your levels of AST and ALT in your blood should not be more than three times the normal limit.My breast cancer is mostly not driven by estrogen or progesterone and is not HER2 positive.I have no remaining invasive cancer in my breast or lymph nodes after initial treatment. DCIS may still be present.I completed at least 6 cycles of chemotherapy with pembrolizumab before surgery.I am not pregnant or breastfeeding and have a recent negative pregnancy test.My heart function is classified as class 2B or better, despite my history of heart issues or treatments.My cancer has not come back after initial treatment and surgery.I have another cancer type, but it won't affect this trial's treatment.I am HIV positive, on treatment, and my viral load has been undetectable for the last 6 months.I do not have any active liver diseases like hepatitis or autoimmune disorders.I haven't needed strong immune system-suppressing drugs in the last 2 years.I am 18 years old or older.I can take care of myself and am up and about more than 50% of my waking hours.My breast cancer was stage T1cN1-2 or T2-4N0-2 according to AJCC 8th edition.My last surgery was no more than 12 weeks ago.All visible cancer was removed from my breast and lymph nodes through surgery.I am not currently using any experimental cancer treatments.Your kidneys are working well enough, with an estimated glomerular filtration rate (eGFR) of at least 15 mL/min/1.73m^2.Your absolute neutrophil count is at least 1,000 per cubic millimeter.Your platelet count is at least 100,000 per cubic millimeter.I have never had invasive breast cancer before, but I may have had DCIS.My breast cancer has not spread to distant parts of my body.
Research Study Groups:
This trial has the following groups:- Group 1: Arm II (observation)
- Group 2: Arm I (pembrolizumab)
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still openings in this experiment for participants?
"The information provided on clinicaltrials.gov confirms that this medical trial is still recruiting patients. This study was initially advertised to the public on May 10th, 2021 and its details were updated lastly on the 31st of May 2021."
Answered by AI
How secure is the Arm II (observation) treatment for patients?
"The safety rating for Arm II (observation) is assessed as a 3 by our group at Power. This score reflects the clinical evidence of its efficacy and multiple sets of data that demonstrate its harmlessness."
Answered by AI
What is the aggregate figure of participants enrolled in this trial?
"Affirmative. According to clinicaltrials.gov, the trial was initially posted on May 10th 2023 and has since received updates as recently as May 31st 2023. Currently, 1295 participants are being recruited from a single site for this medical study."
Answered by AI
Who else is applying?
What site did they apply to?
Smilow Cancer Hospital Care Center at Greenwich
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
I’ve tried 2 other drugs.
PatientReceived 2+ prior treatments
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