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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

51%

Fatigue

37%

Hypertension

25%

Nausea

23%

Weight loss

19%

Back pain

17%

Headache

17%

Mucositis

17%

Diarrhea

16%

Weight gain

15%

Vomiting

13%

Hypothermia

13%

Arthralgia

12%

Anorexia

12%

Alopecia

11%

Anemia

11%

Cough

11%

Upper respiratory infection

10%

Obesity

10%

Flu like symptoms

Pain in extremity

Constipation

Fever

Dizziness

Dyspepsia

Hot flashes

Bone pain

Pruritus

Pain

Dysgeusia

Abdominal pain

Respiratory infection

Nail disorder

Spinal cord compression

Heart failure

Pleural effusion

Ascites

Breast infection

Dyspnea

Gallbladder infection

Dislocation of hip

Renal failure

Bronchial infection

Urinary tract infection

Thromboembolic event

Palmar-plantar erythrodysesthesia syndrome

Osteonecrosis of jaw

Cholecystitis acute

Gastrointestinal infection

100%

80%

60%

40%

20%

Study treatment Arm

Cohort 2: Palbociclib Plus Fulvestrant

Cohort 1 and 2: Capecitabine

Cohort 1: Palbociclib Plus Exemestane

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~3150

Capecitabine

2013

Completed Phase 3

~4280