ASTX727 + Talazoparib for Breast Cancer

Recruiting at1 trial location

Overseen by Kathy Miller, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Kathy Miller

No Placebo Group

Trial Summary

What is the purpose of this trial?

This is a Phase I study to test the safety of a combination of ASTX727 with talazoparib in patients with triple negative breast cancer or hormone resistant/HER2-negative metastatic breast cancer

Research Team

Kathy Miller, MD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for adults with triple negative or hormone resistant/HER2-negative metastatic breast cancer. Participants must have had prior chemotherapy, be in good physical condition, and women of childbearing age must test negative for pregnancy and agree to use contraception. People with active brain metastases or those treated with certain drugs are excluded.

Inclusion Criteria

I had brain treatment over 4 weeks ago, feel stable, and am on a steady or reducing steroid dose.

I have triple negative breast cancer and have had chemotherapy for it after it spread.

My cancer can be biopsied, but I understand it's optional for this trial.

Exclusion Criteria

I haven't had chemotherapy in the last 3 weeks.

I have not started hormone therapy in the last 2 weeks.

My cancer is HER2 positive.

Treatment Details

Interventions

• ASTX727 (Nucleoside Analog)
• Talazoparib (PARP Inhibitor)

Trial Overview The study is testing the safety of combining two drugs: ASTX727 and talazoparib. It's a Phase I trial focusing on patients who've previously undergone at least one chemotherapy regimen for metastatic disease or hormone therapy including a CDK4/6 inhibitor.

Participant Groups

Group I: ASTX727 + Talazoparib Experimental Treatment 2 Interventions

Who Is Running the Clinical Trial?

Kathy Miller

Lead Sponsor

Trials

8

Recruited

300+

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

Astex Pharmaceuticals, Inc.

Industry Sponsor

Trials

97

Recruited

7,400+

Dr. Harren Jhoti

Astex Pharmaceuticals, Inc.

Chief Executive Officer since 2007

PhD in Biochemistry from Birkbeck College, London

Dr. Harold N. Keer

Astex Pharmaceuticals, Inc.

Chief Medical Officer since 2020

MD

Van Andel Institute Stand Up to Cancer Team

Collaborator

Trials

1

Recruited

30+