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PD-L1 Inhibitor

Targeted Therapy for Triple Negative Breast Cancer (PERSEVERE Trial)

Phase 2
Waitlist Available
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.
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.
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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
2 year Disease Free Survival (DFS) ARM 1
Secondary study objectives
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 2021 Phase 3 trial • 693 Patients • NCT02028507
63%
Neutrophil count decreased
55%
Fatigue
34%
Hypertension
27%
Mucositis
24%
Nausea
22%
Weight gain
20%
Diarrhea
20%
Arthralgia
19%
Hypothermia
19%
Upper respiratory infection
19%
Weight loss
18%
Vomiting
17%
Headache
15%
Anorexia
15%
Back pain
15%
Constipation
15%
Pruritus
14%
Cough
12%
Dyspepsia
12%
Bone pain
11%
Abdominal pain
11%
Fever
10%
Flu like symptoms
10%
Alopecia
10%
Pain
10%
Hot flashes
8%
Dizziness
8%
Obesity
8%
Pain in extremity
6%
Anemia
6%
Dysgeusia
5%
Nail disorder
5%
Palmar-plantar erythrodysesthesia syndrome
2%
Respiratory infection
1%
Urinary bladder carcinoma
1%
Acidosis
1%
Bone fracture
1%
Catheter related infection
1%
Dyspnea
1%
Febrile neutropenia
1%
Heart failure
1%
Hematoma
1%
Lymphedema
1%
Non-cardiac chest pain
1%
Pneumonitis
1%
Respiratory failure
1%
Sepsis
1%
Stroke
1%
Suicide attempt
1%
Hip replacement
1%
Tooth infection
1%
Urinary tract infection
1%
Uveitis
1%
Hypercalcemia
1%
Bacteremia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Cohort 1: Palbociclib Plus Exemestane
Cohort 1 and 2: Capecitabine
Cohort 2: Palbociclib Plus Fulvestrant

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
~2850
Capecitabine
2013
Completed Phase 3
~3970
Talazoparib
2021
Completed Phase 2
~2820
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
1,554 Previous Clinical Trials
568,757 Total Patients Enrolled
96 Trials studying Breast Cancer
23,021 Patients Enrolled for Breast Cancer
PfizerIndustry Sponsor
4,635 Previous Clinical Trials
17,736,488 Total Patients Enrolled
114 Trials studying Breast Cancer
41,212 Patients Enrolled for Breast Cancer

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