Targeted Therapy for Triple Negative Breast Cancer

(PERSEVERE Trial)

Recruiting at 13 trial locations

Overseen by Bryan P Schneider, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Bryan Schneider, MD

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This is a 3-arm study stratified by plasma ctDNA. Patients with residual TNBC disease after pre-operative therapy will be assigned to 1 of 3 Arms based on plasma ctDNA positivity and genomic marker(s).

Research Team

Bryan P Schneider, MD

Principal Investigator

Indiana University

Eligibility Criteria

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.

Inclusion Criteria

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 am 18 years old or older.

Exclusion Criteria

You have had strong allergic reactions to the study medications before.

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.

Treatment Details

Interventions

• Atezolizumab (PD-L1 Inhibitor)
• Capecitabine (Antimetabolite)
• Inavolisib (PI3K Inhibitor)
• Talazoparib (PARP Inhibitor)

Trial Overview 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.

Participant Groups

Group I: Arm 1 Experimental Treatment 4 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 2 Active Control 2 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 3 Active Control 2 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.

Who Is Running the Clinical Trial?

Bryan Schneider, MD

Lead Sponsor

Trials

2

Recruited

390+

Vera Bradley Foundation for Breast Cancer

Collaborator

Trials

2

Recruited

390+

Genentech, Inc.

Industry Sponsor

Trials

1,578

Recruited

569,000+

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Pfizer

Industry Sponsor

Trials

4,712

Recruited

50,980,000+

Known For

Vaccine Innovations

Top Products

Viagra, Zoloft, Lipitor, Prevnar 13

Albert Bourla

Pfizer

Chief Executive Officer since 2019

PhD in Biotechnology of Reproduction, Aristotle University of Thessaloniki

Patrizia Cavazzoni

Pfizer

Chief Medical Officer

MD from McGill University

Foundation Medicine

Industry Sponsor

Trials

37

Recruited

17,600+

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Alan Palkowitz

Indiana University

Chief Executive Officer since 2020

PhD in Chemistry from Indiana University

David Ingram

Indiana University

Chief Medical Officer since 2020

MD from Indiana University School of Medicine

Epic Sciences

Industry Sponsor

Trials

7

Recruited

6,600+

Vera Bradley Foundation for Breast Cancer Research

Collaborator

Trials

1

Recruited

200+