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Nucleoside Analog

ASTX727 + Talazoparib for Breast Cancer

Phase 1

Waitlist Available

Led By Kathy Miller, MD

Research Sponsored by Kathy Miller

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients with triple negative breast cancer must have received at least one prior chemotherapy regimen for metastatic disease

Adequate organ function as indicated by: Total bilirubin </= ULN (upper limit of normal) (except in patients with documented Gilbert's disease, who must have a total bilirubin </= 3.0 mg/dL), Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) </= 3.0 x ULN (</= 1.5-3.0 x baseline if baseline is abnormal), Calculated creatinine clearance of >/= 60 mL/min using the Cockcroft-Gault formula, Absolute neutrophil count (ANC) >/= 1.5 K/mm3, Platelets >/= 100 K/mm3, Hemoglobin (Hgb) >/= 9.0 g/dL

Must not have

Chemotherapy within 3 weeks of registration

Hormone therapy within 2 weeks of registration

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion i.e up to 1 year

Awards & highlights

Summary

This trial is testing a new cancer treatment to see if it is safe for patients with triple negative breast cancer or hormone resistant/HER2-negative metastatic breast cancer.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

While specific side effects aren't listed here, common ones from similar treatments include nausea, fatigue, blood cell count changes, potential allergic reactions, and organ-specific issues like liver function alterations.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My liver and kidney functions are normal, and my blood counts are within healthy ranges.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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My cancer is hormone-positive, HER2-negative, and has worsened despite treatment with an endocrine therapy and a CDK4/6 inhibitor.

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My breast cancer has returned or spread and cannot be cured with surgery or radiation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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My cancer is HER2 positive.

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I have been treated with specific DNA-targeting drugs before.

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I have active or symptomatic brain or spinal cord problems.

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I have not had radiation therapy in the last 2 weeks.

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I need continuous treatment with strong P-gp inhibitors.

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I have previously been treated with a PARP inhibitor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion i.e up to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion i.e up to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion i.e up to 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Rate of dose limiting toxicity

Safety of ASTX727 plus talazoparib using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v 5.0

Secondary outcome measures

Clinical benefit response for hormone receptor positive/ HER2 negative subjects

Clinical benefit response for triple negative disease subjects

Overall response rate

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: ASTX727 + TalazoparibExperimental Treatment2 Interventions

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Talazoparib

FDA approved

ASTX727

2018

Completed Phase 3

~240

0 / 14Eligibility criteria met

Find a Location

Who is running the clinical trial?

PfizerIndustry Sponsor

4,595 Previous Clinical Trials

12,868,736 Total Patients Enrolled

114 Trials studying Breast Cancer

36,195 Patients Enrolled for Breast Cancer

Astex Pharmaceuticals, Inc.Industry Sponsor

95 Previous Clinical Trials

7,927 Total Patients Enrolled

1 Trials studying Breast Cancer

Van Andel Institute Stand Up to Cancer TeamUNKNOWN

Media Library

ASTX727 (Nucleoside Analog) Clinical Trial Eligibility Overview. Trial Name: NCT04134884 — Phase 1

Breast Cancer Research Study Groups: ASTX727 + Talazoparib

Breast Cancer Clinical Trial 2023: ASTX727 Highlights & Side Effects. Trial Name: NCT04134884 — Phase 1

ASTX727 (Nucleoside Analog) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04134884 — Phase 1

~6 spots leftby Jul 2025

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