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PD-L1 Inhibitor
Targeted Therapy for Triple Negative Breast Cancer (PERSEVERE Trial)
Phase 2
Recruiting
Led By Bryan P Schneider, MD
Research Sponsored by Bryan Schneider, MD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must have histologically or cytologically confirmed triple negative (ER-/PR-/HER2-) invasive breast cancer per pathology report
Must have clinical stage I-III at diagnosis (AJCC 8th edition) based on initial evaluation by physical examination and/or breast imaging prior to neoadjuvant chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights
PERSEVERE Trial Summary
This trial is testing whether different targeted therapies can improve outcomes for women with residual Triple Negative Breast Cancer after pre-operative treatment.
Who is the study for?
This trial is for women with residual Triple Negative Breast Cancer (TNBC) after pre-op therapy. They must have completed neoadjuvant chemotherapy and surgery, not be pregnant, and agree to use contraception. Excluded are those with chronic hepatitis B, uncontrolled diseases, recent investigational drug use, certain eye conditions or diabetes requiring treatment, active second malignancy other than specific skin/prostate cancer types, HIV without undetectable viral load in the past 6 months, recent heart issues or severe allergies to study meds.Check my eligibility
What is being tested?
The study tests three treatments based on plasma ctDNA positivity and genomic markers: Pembrolizumab (an immunotherapy), Capecitabine (a chemotherapy drug), Talazoparib and Inavolisib (targeted therapies). Patients will be stratified into one of these three arms depending on their individual tumor DNA characteristics.See study design
What are the potential side effects?
Potential side effects include immune-related reactions like inflammation in organs from Pembrolizumab; hand-foot syndrome, diarrhea from Capecitabine; anemia or fatigue from Talazoparib; and high blood sugar levels or rash from Inavolisib. Each patient's experience may vary.
PERSEVERE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My breast cancer is confirmed to be triple negative.
Select...
My breast cancer was stage I-III when first diagnosed.
Select...
I have finished chemotherapy before surgery for my current cancer.
Select...
I still have a lot of cancer left after chemo before my surgery.
Select...
I have had surgery to remove my primary tumor completely.
PERSEVERE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
2 year Disease Free Survival (DFS) ARM 1
Secondary outcome measures
1 year Disease Free Survival (DFS)
2 year Disease Free Survival (DFS) in ARM 2
2 year Disease Free Survival (DFS) in ARM 3
+4 moreSide effects data
From 2020 Phase 2 & 3 trial • 151 Patients • NCT0309387063%
Nausea
58%
Fatigue
54%
Diarrhoea
50%
Decreased Appetite
46%
Vomiting
42%
Pyrexia
42%
Hypokalaemia
38%
Abdominal Pain
33%
Constipation
33%
Blood Bilirubin Increased
29%
Abdominal Distension
29%
Hyponatraemia
29%
Dizziness
29%
Oedema Peripheral
29%
Back Pain
25%
Hypotension
25%
Stomatitis
25%
Palmar-plantar Erythrodysaethesia Syndrome
25%
Dehydration
25%
Anaemia
21%
Aspartate Aminotransferase Increased
21%
Dyspnoea
21%
Chills
21%
Dyspepsia
21%
Asthenia
21%
Proteinuria
17%
Platelet Count Decreased
17%
Alanine Aminotransferase Increased
17%
Rash
17%
Ascites
13%
Hyperbilirubinaemia
13%
Cough
13%
Abdominal Pain Upper
13%
Blood Creatinine Increased
13%
Hypomagnesaemia
13%
Dry mouth
13%
Dyspnoea exertional
13%
Weight Decreased
13%
Hypoalbuminaemia
13%
Muscular weakness
13%
Urinary tract infection
8%
Depression
8%
Gastrooesophageal Reflux Disease
8%
Gamma-glutamyltransferase increased
8%
International normalised ratio increased
8%
Paraesthesia
8%
Influenza like illness
8%
Dysphonia
8%
Malaise
8%
Hypoaesthesia
8%
Faeces discolored
8%
Hypoglycemia
8%
Acute Kidney Injury
8%
Enterocolitis
8%
Hematemesis
8%
Hyperkalaemia
8%
Hypocalcaemia
8%
Blood alkaline phosphatase increased
8%
Epistaxis
8%
Bile duct obstruction
8%
Oral pain
8%
Neutrophil Count Decreased
8%
Myalgia
8%
Insomnia
8%
Early satiety
8%
Rhinitis allergic
8%
Bursitis
8%
Musculoskeletal pain
8%
Anxiety
8%
Dysgeusia
8%
Acute kidney injury
8%
Cholangitis
4%
Cardiac arrest
4%
Rash generalized
4%
Respiratory Failure
4%
Septic shock
4%
Small intestinal obstruction
4%
Spinal cord compression
4%
Toxic leukoencephalopathy
4%
Peripheral Sensory Neuropathy
4%
Haematemesis
4%
Hypercalcaemia
4%
Hyponatremia
4%
Hypoxic-ischaemic encephalopathy
4%
Ischaemic stroke
4%
Lung Infection
4%
Metabolic acidosis
4%
Aspiration
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo and Capecitabine - Part 1
Varlitinib and Capecitabine - Safety Lead-In
Varlitinib and Capecitabine - Part 1
PERSEVERE Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Arm 1Experimental Treatment4 Interventions
Arm 1a: Patients who are ctDNA-positive and harbor a genomic target. DNA repair pathway = talazoparib + capecitabine (CLOSED)
Arm 1b: Patients who are ctDNA-positive and harbor a genomic target. Immunotherapy pathway = pembrolizumab + capecitabine (CLOSED)
Arm 1c: Patients who are ctDNA-positive and harbor a genomic target. PI3K Pathway = inavolisib + capecitabine ---> +/- standard of care pembrolizumab
Arm 1d: Patients who are ctDNA-positive and harbor a genomic target. DNA Repair + Immunotherapy = talazoparib + capecitabine +/- standard of care pembrolizumab
Group II: Arm 2Active Control2 Interventions
Arm 2 subjects have plasma ctDNA positive but do not have a genomically driven treatment option. Treatment of physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician.
Group III: Arm 3Active Control2 Interventions
Arm 3 subjects have plasma ctDNA negative. Treatment of patient and physician's choice will be given with consideration for capecitabine and pembrolizumab. Dose, schedule and duration of treatment to be determined by treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010
Capecitabine
2013
Completed Phase 3
~3420
Talazoparib
2021
Completed Phase 2
~2770
Inavolisib
2021
Completed Phase 2
~260
Find a Location
Who is running the clinical trial?
Bryan Schneider, MDLead Sponsor
1 Previous Clinical Trials
193 Total Patients Enrolled
1 Trials studying Breast Cancer
193 Patients Enrolled for Breast Cancer
Genentech, Inc.Industry Sponsor
1,541 Previous Clinical Trials
567,946 Total Patients Enrolled
96 Trials studying Breast Cancer
23,021 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,570 Previous Clinical Trials
10,915,829 Total Patients Enrolled
111 Trials studying Breast Cancer
36,247 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had strong allergic reactions to the study medications before.I need radiotherapy after my breast-conserving surgery unless my doctor advises against it.I am willing to use effective birth control during the study.I have chronic hepatitis B with an undetectable viral load in the last 6 months.I have diabetes and am currently on treatment, or I have Type 1 diabetes.I have or had eye inflammation or infection.I am 18 years old or older.I have or had inflammatory bowel disease like Crohn's or ulcerative colitis.My breast cancer is confirmed to be triple negative.I need ongoing treatment for high calcium levels in my blood.Women who could become pregnant must have a negative pregnancy test before joining the study.I do not have any eye conditions needing treatment during the study.I have received pembrolizumab before surgery and can continue it during screening.Any side effects from previous treatments have mostly gone away.I do not have an active cancer other than non-dangerous skin cancer or incidental prostate cancer.I am HIV-positive, on treatment, and my viral load is undetectable.I have not had a heart attack or unstable angina in the last year.My cancer has spread to other parts of my body.I have been mostly active and able to carry on all pre-disease activities without restriction recently.My recent lab tests are within normal ranges for starting treatment.My breast cancer was stage I-III when first diagnosed.I agree to provide blood and tumor samples for genetic testing.I do not have any active inflammation in my bowels.I have symptoms of lung problems, like trouble breathing.My doctor does not consider my infections serious.I have finished chemotherapy before surgery for my current cancer.I still have a lot of cancer left after chemo before my surgery.I have had surgery to remove my primary tumor completely.I cannot swallow pills.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2
- Group 2: Arm 1
- Group 3: Arm 3
Awards:
This trial has 1 awards, including:- 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 any other investigations that have featured Capecitabine?
"First examined in 2005 at Withington Hospital, capecitabine has been the subject of 656 studies so far. At present, 727 clinical trials are being conducted with many based out of Madison, Wisconsin."
Answered by AI
Is enrollment still open for this trial?
"Affirmative. The clinical trial's page on clinicaltrials.gov indicates that the study, which was initially posted on August 24th 2021, is presently seeking participants. Approximately 197 patients are needed to be enrolled from 5 different sites."
Answered by AI
What are the key applications of Capecitabine?
"Capecitabine is a commonly prescribed medication for treating brca1 gene, but it can also be used as part of pharmacotherapy, or to address refractory fallopian tube carcinoma and small cell lung cancer."
Answered by AI
Are any of the participating sites for this research trial located in North America?
"This trial is being conducted across numerous sites, such as the University of Wisconsin in Madison, Memorial Healthcare System located in Hollywood, Florida and Georgetown University situated in Washington D.C., among other 5 locations."
Answered by AI
How does Capecitabine measure up in terms of safety for human consumption?
"A score of 2 was ascribed to capecitabine's safety as there is evidence that it is safe, however no clinical data exists supporting its efficacy."
Answered by AI
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