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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
No Placebo-Only Group

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 below
Select...
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 have received pembrolizumab before surgery and can continue it during screening.
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.
Select...
I need radiotherapy after my breast-conserving surgery unless my doctor advises against it.
Select...
Any side effects from previous treatments have mostly gone away.
Select...
I am willing to use effective birth control during the study.
Select...
I am 18 years old or older.
Select...
I have been mostly active and able to carry on all pre-disease activities without restriction recently.
Select...
I agree to provide blood and tumor samples for genetic testing.
Select...
My recent lab tests are within normal ranges for starting treatment.

PERSEVERE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

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 more

Side effects data

From 2020 Phase 2 & 3 trial • 151 Patients • NCT03093870
63%
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%
Dyspnoea
21%
Dyspepsia
21%
Asthenia
21%
Aspartate Aminotransferase Increased
21%
Proteinuria
21%
Chills
17%
Platelet Count Decreased
17%
Alanine Aminotransferase Increased
17%
Rash
17%
Ascites
13%
Cough
13%
Abdominal Pain Upper
13%
Blood Creatinine Increased
13%
Dry mouth
13%
Dyspnoea exertional
13%
Weight Decreased
13%
Hypoalbuminaemia
13%
Hyperbilirubinaemia
13%
Hypomagnesaemia
13%
Muscular weakness
13%
Urinary tract infection
8%
Gastrooesophageal Reflux Disease
8%
International normalised ratio increased
8%
Hypoaesthesia
8%
Paraesthesia
8%
Faeces discolored
8%
Hypoglycemia
8%
Acute Kidney Injury
8%
Enterocolitis
8%
Hematemesis
8%
Hyperkalaemia
8%
Hypocalcaemia
8%
Blood alkaline phosphatase increased
8%
Gamma-glutamyltransferase increased
8%
Dysphonia
8%
Epistaxis
8%
Bile duct obstruction
8%
Depression
8%
Oral pain
8%
Malaise
8%
Neutrophil Count Decreased
8%
Myalgia
8%
Insomnia
8%
Early satiety
8%
Influenza like illness
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

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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 3
~2070
Capecitabine
2013
Completed Phase 3
~3420
Talazoparib
2021
Completed Phase 2
~2740

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
1,538 Previous Clinical Trials
567,668 Total Patients Enrolled
96 Trials studying Breast Cancer
23,021 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,547 Previous Clinical Trials
11,422,610 Total Patients Enrolled
109 Trials studying Breast Cancer
33,407 Patients Enrolled for Breast Cancer

Media Library

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Breast Cancer Research Study Groups: Arm 2, Arm 1, Arm 3
Breast Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT04849364 — Phase 2
Atezolizumab (PD-L1 Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04849364 — Phase 2

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

What is the sample size for this experiment?

"This medical trial necessitates the involvement of 197 patients meeting certain criteria. Epic Sciences is taking charge, operating it from University of Wisconsin in Madison and Memorial Healthcare System in Hollywood, Florida."

Answered by AI
~131 spots leftby Jan 2029