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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
Must not have
Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes
Active inflammatory (e.g., uveitis or vitritis) or infectious (e.g., conjunctivitis, keratitis, scleritis, or endophthalmitis) conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is confirmed to be triple negative.
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My breast cancer was stage I-III when first diagnosed.
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I have finished chemotherapy before surgery for my current cancer.
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I still have a lot of cancer left after chemo before my surgery.
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I have had surgery to remove my primary tumor completely.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have diabetes and am currently on treatment, or I have Type 1 diabetes.
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I have or had eye inflammation or infection.
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I have or had inflammatory bowel disease like Crohn's or ulcerative colitis.
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I need ongoing treatment for high calcium levels in my blood.
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I do not have an active cancer other than non-dangerous skin cancer or incidental prostate cancer.
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I do not have any active inflammation in my bowels.
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I have symptoms of lung problems, like trouble breathing.
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I cannot swallow pills.

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%
Blood Bilirubin Increased
33%
Constipation
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%
Aspartate Aminotransferase Increased
21%
Chills
21%
Dyspepsia
21%
Asthenia
21%
Proteinuria
17%
Platelet Count Decreased
17%
Alanine Aminotransferase Increased
17%
Rash
17%
Ascites
13%
Cough
13%
Abdominal Pain Upper
13%
Hypomagnesaemia
13%
Blood Creatinine Increased
13%
Hyperbilirubinaemia
13%
Dry mouth
13%
Dyspnoea exertional
13%
Weight Decreased
13%
Hypoalbuminaemia
13%
Muscular weakness
13%
Urinary tract infection
8%
Influenza like illness
8%
Gamma-glutamyltransferase increased
8%
Paraesthesia
8%
Dysphonia
8%
Malaise
8%
Faeces discolored
8%
International normalised ratio increased
8%
Hypoaesthesia
8%
Gastrooesophageal Reflux Disease
8%
Depression
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

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
1,542 Previous Clinical Trials
567,880 Total Patients Enrolled
96 Trials studying Breast Cancer
23,021 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,595 Previous Clinical Trials
12,868,573 Total Patients Enrolled
113 Trials studying Breast Cancer
35,998 Patients Enrolled for Breast Cancer

Media Library

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